Some of the Long-serving Contributors to SAMED.

1.

Celebrating 30 Years

Remarks by the Chairperson

SAMED - One voice for the

South African Medical Device Industry

SAMED Board of Directors

SAMED Financials

SAMED Committee Reports

SAMED Association Member News

Compliance and SAMED

SAMED's Offerings

SAMED Activities 2015/2016

SAMED Events 2015/ 2016

About the Medical Device Industry

Innovative Medical Devices brings

value to healthcare

SAMED New and Existing Members

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4.

6.

9.

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21.

24.

25.

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31.

33.

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38.

INDEX

2015 saw SAMED celebrate its 30th Anniversary. Three decades ago, the Association, (then known as the South African Medical Industries Manufacturers' Association) was formed in response to the DoH Medicines Control Council at that time under Johan Schlebusch to a call for the Registration of Medical Devices. All manufacturers were concerned about this

intent - and Dr Robert Bowling of J & J convened a meeting at Iso-Ster in Isando to discuss this issue. Andre du Plessis (then CEO of Iso Ster) was elected as the Association's first Chairman.

Celebrating 30 Years

Tanya VogtSAMED

Executive Officer

SAMED was Actively Engaged with the MCC on Device Regulation in 1985

The Association Membership was restricted to local manufacturers only for the initial 7 years of its existence, but was later opened up to include 'traders'. Many iterations of regulations occurred - including a full Working Group who developed a full blown regulatory pack which was presented to the then MoH Nkosozana Dlamini- Zuma.

They never saw the light of day because SAMDRA (SA Medical Devices Regulatory Act) came into being (for a short while) but this was later scrapped.

To date, SAMED actively promotes that devices are regulated under a separate authority which it is hoped will come into being under SAHPRA (SA Health Products Regulatory Authority).

Other key issues of the day were:

1. Registration of Medical Devices2. Re-use of Single Use Devices3. Ethical principles and practices

2.

The Re-Use of Single-Use Devices was a Hot Topic 28 Years Ago

Herewith a brief summary of SAMED's key activities over the last 30 years:

1985-2015 Countless submissions on Medical device and IVD regulations

1994 First SAMED Code of Marketing and Business Practice

1995 Open Association to incorporate importers

1999 Anesticum Pulseline Competition Commission Ruling

2003

2003

SAMED joined NAPPI Advisory Board

First SAMED Salary survey

2005 New Constitution adopted

2006 SAMED contributes to the Health Charter draft

2007

2007

2008

2008

2008

2009

Presented to Portfolio Committee ofHealth and succeeded in getting Act 101 as amended by Act 72 to read‘Medical Devices and IVD’s and not‘health products’

Pledge to stop rebates, SAMEDtransparent invoicing model includedin Code of Business Practice

2010

2011-2012

2011

SAMED became a Member of Marketing Code Authority (MCA)

2011 SAMED joined Industry Task Group (ITG)

2012 Company Representatives in theClinical Environment (CRICE) launched:6700 people trained to date

2013

2014

2014-2015

SAMED moved offices to Witkoppen

Submissions to Competition Commission’s Health Market Inquiry

SAMED appointed by National Department of Health as SA IndustryRepresentative Member of Asian Harmonisation Working Party (AHWP)

SAMED develops reimbursement \dossier template - Momentum Healthadopts it

SAMED rebranded, new logo:Advancing Innovation Responsibly

SAMED commissions a Deloitte survey into the structure and value of theIndustry

Media campaign and writing to Ministers of Health, dti and Treasury and significantly reduced outstanding payments for Members in Gauteng. Prompted Gauteng Health to review and implement payment processesespecially for consignment stock

SAMED became a Member of Global Medical Technology Alliance (GMTA)

Tanya Vogt appointed as Department of Science and Technology representative onStrategic Health Innovation Partnership (SHIP)

Apart from the above we have made submissions on:

HTA, B-BBEE, Procurement regulations, NHI, IP policy, HPCSA regulations, booklet 5 and doctor trading, Medical schemes regulations, Prescribed Minimum Benefits (PMB’s).

We also have a number of position papers on:

ReimbursementRegulationsRegistriesSingle Use Devices CongressesDraft position paper on procurement of medical devices

Today, SAMED's Membership has reached 123 Ordinary, 11 Associate and 3 Association Members and continues to grow. The Association employs 3 full time staff and has 12 committees with 141 volunteer Member company participants, whose expertise in regulatory, reimbursement, compliance and international medical technology issues is second to none.

From its humble beginnings, SAMED has played a vital role in the success and sustainability of the Medical Device industry in South Africa over the past 30 years. Our industry has a proud legacy of helping patients, providing much needed jobs and improving the efficiency and effectiveness of our nation's health care system.

Please join me in celebrating SAMED's 30 year anniversary and acknowledging the important role played by the numerous past and present contributors to SAMED.

Your Executive Officer, Tanya Vogt

3.

SAMED's Strategy

Key Highlights of SAMED Activities over the Past Year

SAMED's Board of Directors last year developed a four year strategic plan with key objectives. To this end SAMED is increasingly seen as the voice of the industry by many of our stakeholders.

As an industry Association we are highly knowledgeable about industry trends and developments, which we

utilize in our negotiations with key stakeholders.

SAMED meets on a regular basis with national and provincial government, regulatory bodies, doctor societies, the private hospital groups, procurement departments, other health product industry Associations, the Portfolio Committee of Health and others like the SABS, to pro-actively influence decisions that impact the Medical Device industry.

There is a perception out there that the SAMED Board is inundated by Multi-National Companies and follows their strategic objectives. This is far from the truth! The Board is made up of a multitude of key people elected by you, the Membership and when we meet, the SAMED Chairperson has always ensured that Board Members represent the industry as a whole and not their individual company concerns. There are a number of good governance checks and balances within the Board to guarantee that a personal agenda is not pushed through. I would like to assure all Members that Board discussions are quite robust when it comes to controversial issues.

We are aware of the difficult economic times currently facing our industry. We have tried within the best of our capability without contravening competition law, to provide information to our Members on a regular basis on possible solutions so that our Members can make informed decisions about their business.

This past year, saw Draft Medical Device and IVD Regulations become more eminent than ever before and SAMED has had extensive input into these drafts.

Remarks by the Chairperson We are constantly engaged with the MCC, trying to ensure that there are no surprises for our Members.

This past year also saw the Health Market Inquiry into the cost of private healthcare in South Africa. As an industry body we have made numerous submissions and presented to the panel to voice the industry's view point.

For the first time in SAMED's history, we hosted the Minister of Health at a breakfast briefing; we received phenomenal feedback from both our Members and the Minister's office who have indicated that they would like further engagement with us.

SAMED hosted two highly successful conferences in 2015, with positive feedback and we continue to strive for the same standard in our upcoming conference this year.

We continue to engage with all stakeholders on the issue of non-payment by government departments to our Members. While the situation is not 100%, it is definitely improving and it appears that SAMED's engagement with Gauteng Health is paying off. Our strategy going forward is to now engage with other provincial health departments to meet the same success.

We welcome 18 new Members this past year and would like to thank all current Members for their support.

SAMED is a financially responsible Association with good fiduciary practices and whilst we are an Association, we appreciate that we are dealing with Members' money. As such we are audited to ensure that there is transparency and clarity around the finances of the Association.

We have a number of Committees whose updates and successes are within this report. I would like to personally thank all Committee Chairpersons and their Committee Members for their contribution and tireless hard work.

As with any Association, SAMED hasmet with a number of challenges this year.

Financials

Committees

Challenges

Jeff HamptonSAMED

Chairperson

4.

In terms of Medical Device and IVD Regulations, we are still uncertain with regards to timeframes of implementation and licencing of our companies.

Another key challenge is that of Combination Medical Devices, two High Court rulings have determined that the Medicines Control Council does not have jurisdiction over the registration of Combination Medical Devices that are classified as Medical Devices ie where the primary mode of action resides with the device component. While we have met with some success with some of our stakeholders, we are still struggling to obtain a public announcement from the MCC on this issue.

SAMED and its board are constantly challenged to demonstrate value for its Members. We urge Members to get involved in the activities and the committees. So send through your employee nominees to participate on the various SAMED committees. I do believe that in comparison to other health product Associations, ours is one of the most effective.

We welcome Sada, our Project Officer and thank her, Tanya and Nicky for the unwavering work they do to ensure that the Association runs smoothly and effectively.

I would like to thank all the Board Members for their time and expertise, as well as the Committee Chairpersons for all their hard work.

Special thanks to Mike Howe-Ely for his years of service, for his wisdom and input into the Board in numerous roles including Chair of SAMED. I would also like to thank Judith Horne for her unbelievable insight in reimbursement and HTA and her service to the Board. Both Mike and Judith will be missed and their expertise will be hard to replace.

Finally, I would like to thank the Members for their contributions and their questions in order to keep us on the straight and narrow and ensure we are a more needs orientated Association.

A Word of Thanks

Retired Board Member, Mr Mike Howe-Ely and current Board Member Dr Terence Moodley enjoying a final 2015 Board meeting lunch

SAMED Chairperson, Mr Jeff Hampton toasting fellow Board Members at the final 2015 Board meeting lunch

Retired Board Member, Ms Judith Horne and current Board Member Ms Robyn Howes enjoying a final 2015 Board meeting lunch

5.

SAMED is The Voice of the Medical Device Industry in South Africa. Established in 1985, the Association has grown significantly in recent years and is now recognised as an important stakeholder in the South African healthcare industry. SAMED represents the interests of 160+ Medical Device, Medical Equipment and In Vitro Diagnostics Companies in South Africa.

“SAMED’s Vision is to develop asustainable Medical Device industry by responsibly improving patient access

to innovative health technology.”

African Medical Device Industry One voice for the South

SAMED is committed to safeguarding and promoting the interests of its Members, encouraging ethical principles and practices, promoting innovation and better patient outcomes and ensuring effective representation with all relevant authorities whether public or private.

SAMED has strived to continuously communicate the value that it adds to its Members and industry stakeholders. SAMED Members:

enjoy regular, industry-related information gathered from numerous sources, including government and private sector

have access to advice and support regarding the regulation of devices, both abroad and locally

have access to regular networking sessions, enabling Members to connect with other individuals and businesses and benefit from opportunities, while maintaining absolute adherence to all competition laws

have access to contacts across government healthcare departments, tender boards, private sector health care groups and health care professionals

benefit from incoming product and tender enquiries (local and overseas), information requests and trade delegation requests

SAMED has an Association with a number of other international agencies, including AHWP (The Asian Harmonisation Working Party), GMTA (Global Medical Technology Alliance), Advamed and Eucomed. SAMED understands the need to anticipate the changes in the South African healthcare industry over the short-to-medium term to continue adding value for its Members. The historical spending patterns in the industry are undergoing change and both the public and private sectors are affected by these trends. As such, last year the SAMED Board developed a four year strategic plan with the following key objectives:

Increase the awareness of all stakeholders as the authentic voice of the Medical Devices industry and actively promote ethical business and marketing practices.

1.

Continually demonstrate value to Members and communicate that added value. Although SAMED represents most of the industry, Membership should be seen as valuable to all firms in the industry.

2.

Proactively influence and drive for appropriate regulations by engaging with stakeholders and consumers of our products.

3.

SAMED should be a main participant in the setting of standards in the health industry in general and the Medical Devices industry in particular.

4.

Actively promote the transformation of our industry in particular, and health services in general.

5.

To support the effective implementation of the Strategy, the Board also felt it important that all SAMED activities are guided by the following key values:

Representivity of all our Members

Non-competitive initiatives and projects. SAMED encourages open, fair and ethical competition as we believe that this is in the best interests of the industry and society based on common ground

SAMED will speak with a unified voice and have a clear mandate when engaging with any stakeholders

SAMED

6.

Engaging proactively in a supportive relationship with government to influence policy affecting our Members

Respect of Members' intellectual property

Adherence with all competition laws at every gathering

SAMED's 2015/2016 activities and engagements have been guided by these objectives and values.

7.

Marlon BurgessChief Executive

Officer MDG Health

Solutions

Leanne Cook Sales & Marketing

DirectorJohnson & Johnson

Medical

William Hodson MISA

Representative

Jeffry Hampton SAMED

ChairpersonHead of New Business

Africa Baroque Medical

SAMED Executive Committee

SAMED Board of Directors

Marlon BurgessChief Executive

Officer MDG Health

Solutions

Leanne Cook Sales & Marketing

DirectorJohnson & Johnson

Medical

Rob Millar SAMED

Treasurer CEO

Condor Medical

Ruwalda ShaikhSAMED Vice-ChairCountry Director Boston Scientific

SA

Albert Denoon Chief Executive

Officer Baroque Medical

Malan de Villiers MDMSA

Representatvie

Reiner Gabler Chief Executive

Officer Gabler Medical

9.

Jeffrey Hampton SAMED

ChairpersonHead of New Business

AfricaBaroque Medical

William Hodson MISA

Representative

Robyn HowesSALDA

Representative

Anthony Lowther Country Manager

Stryker SA

Rob MillarSAMED

Treasurer CEO

Condor Medical

Dr Terence Moodley Business Director:Integrated Health

Solutions Medtronic (Pty) Ltd

Tanya Watson Reimbursement

Manager Medtronic

Madeleine Pearce Senior Quality &

Regulatory Systems Manager

Philips Healthcare

Mike Howe-Ely Regional Director

Medtronic(Retired)

Ruwaida Shaikh SAMED Vice-Chair Country Director Boston Scientific

SA

Vassie Ponsamy Managing DirectorSub Saharan Africa

Region Smith & Newphew

Judith Horne Regional Managing

Director Smith & Nephew

(Retired)

Resigned Board Members

Co-opted Board Member for 2016 / 2017

10.

Rob Millar SAMED

Treasurer

Financials SAMED

The Aud i t ed F i n anc i a l Statements for the year ended 31st December 2015 were approved by the SAMED Board on the 26th April 2016.

The Association performed well with an increase in overall income of 29% over the previous year. This was due in the main to our Conference income growing by almost R630,000. Such fees accrued f rom both our annua l

symposium and the regulatory conference held late in 2015.

The expenditure showed a 13% increase year on year, mostly attributable to the concomitant increase in symposia/conference costs (R500,000) and fully annualised employee costs (R319,000).

A 27% increase in Member meeting costs reflects an increase in service to the Membership over the year.

In general all other operating costs were well contained - allowing us to end the year with a surplus of R1,235,626 and the resultant retained income (equity) of R3,056,000.

SAMED's financial position remains robust with reserves in hand which will allow the Association to address most unforeseen challenges into the future.

Thank you to all of our Members for your continued support over the 30 years of the Associations existence.

11.

Avanthi Bester Africa Committee

Chairperson

Albert DenoonCongress Committee

Chairperson

Marlon BurgessGovernmentProcurement CommitteeChairperson

Government Procurement Committee

The SAMED Government Procurement Committee continued to make progress with the Gauteng Department of Health with respect to reducing the annual Debtors book for its Members. A recent survey showed that the Debtors book has reduced almost 50% in the last two years due to efficiencies as a

result of e-invoicing and the new Consignment Stock Process supported by SAMED. However, problems still exist with procurement and payment blockages at financial year end and SAMED will continue to work with the Gauteng Department of Health and all provincial HOD's to find solutions to this recurring problem.

The first set of National Tenders incorporating specifications of the Essential Equipment list were implemented by National Treasury in the last financial

SAMED is pleased that its recommendations were taken into consideration by National Treasury in rolling out this project. Thanks to all the companies that volunteered Committee Members to participate in this important project. SAMED has made considerable progress in this area to the point where it has become, what we consider to be a technical partner to National Treasury.

SAMED is partnering with the Gauteng Department of Health to support its inventory management process. SAMED supported the Western Cape Department of Health in a similar manner in 2012 with its Orthopaedic tender rollout. In this manner, SAMED is engaging in PPPs (Public Private Partnerships) and ensuring essential Healthcare services are delivered.

SAMED is pleased to announce that the dti, SABS, DoH, SANAS, forum has convened on two occasions and considerable progress has been made. The most significant being the drafting of a Service Level Agreement (SLA) between the National Department of Health and the SABS to ensure efficient rollout of tender specifications. SAMED will continue to play a key role in improving the formulation of tender specifications and advocating for efficient procurement processes in general.

In the next financial year the committee is looking to hold workshops with the provincial HOD's for Health as well as the CEO's of state hospitals in Gauteng. A key objective this year is to support and contribute to SAMED's annualconference where this year's conference will have one day solely dedicated to “Best Practice in Procurement of Medical Devices”.

The Congress Committee has continued in its efforts to interact with Associations and Societies to promote the objectives and processes set out in its Principle Document, with the focus on a Better Return on Investment for all Stakeholders. Although reactions and buy-in has been mixed, we have achieved moderate success with at least three of the major organisations.

The SAMED Congress Committee is satisfied with the progress made in 2015 and will continue in its endeavours during 2016.

SAMED Members engaging with the panel at the MedTech Workshop

SAMED south african medical device industry association

advancing innovation responsibly

14.

Judith HorneHealth Economics and

Reimbursement Committee

(Outgoing Chairperson)

This year saw three sub Working Groups established in support of SAMED's overall strategic objectives.

Firstly, the HTA and Health Economics Work Group, the Professional Societies' Alignment Work Group and the Council of Medical Scheme (CMS) Projects Work

Group. Ours is a busy and productive committee and on reflection, we achieved a great deal, in conjunction with the SAMED office team who provided great guidance, support of, and participation in, our initiatives.

Our HTA & Health Economics Work Group assisted in the development of the programme for Day One of the SAMED Annual Conference, built around the Life Cycle of Technology, how it is reviewed by multiple stakeholders and including perspectives on coding & tariff development, HTA models, and the outsourcing of service providers. Together with BrandTech, we ran three sold-out Reimbursement & HTA Workshops in July, September and November. These workshops provide valuable grounding in the discipline of HTA & HE and how to successfully integrate business, marketing & reimbursement strategies for Medical Devices. The workshops were 50% subsidised by SAMED, with support from Mark Brand and venue hosts, Johnson & Johnson, 3M and Medtronic. In 2016, we hope to continue with this successful programme and provide an HTA 102 Workshop to be held with Funders and private hospitals.

HTA Process Mapping in the Private Sector is underway, with meetings held with Mediclinic, Medscheme and Metropolitan. Further meetings are scheduled this year. Two meetings were held in the State Sector, with KZN DoH Supply Chain Management and with the NDoH Essential Medicines Department, in conjunction with the Government Procurement & Logistics Committee. Charlotte Maxeke Medical Research Cluster (CMeRC) has developed a Rapid HTA tool and we plan to work closely with Debjani Mueller, an HTA consultant for the University of Witwatersrand to educate SAMED Members on its use.

We held a general Membership workshop with the Discovery Health Surgical Risk Management and Clinical Policy Unit teams in early November and were very pleased that 103 SAMED Members attended and were able to interact with them on general issues and others important to their businesses, as well as to learn first-hand about Discovery Health initiatives underway. This engagement with Funders will continue throughout 2016.

Health Economics and Reimbursement Committee

SAMED Members engaging with Discovery on the company’s current health initiatives

Some of main activities of the year included:

Our Professional Societies' Alignment Work Group, worked closely with the SAOC on the development of a Guideline with protocols for Chemotherapy and Radiotherapy published in January 2015.

SAPPF presented to us concerning skills development, appropriate training and insurance of HCPs in the field of OBGYN. SAMED Member companies were requested to provide details of equipment and consumables, as well as training modules and CPD programmes in this field.

Our CMS Work Group held several meetings with the CMS Clinical and Accreditation Units to progress and finalise our Medical Device appropriate guidelines for Managed Care Organisations. This objective was not completed, as our focus had to shift to timely and effective commentary on the CMS' proposals regarding Low Cost Benefit Options and draft amendments to Regulations 5 and 8 of the Medical Schemes Act. In 2016, we will continueto meet with the CMS AccreditationUnits and further our work withregards to the finalisation to theMedical Device guidelines.

15.

My thanks to our committee Members who gave of their time and expertise to ensure we could hold a number of meetings and workshops during the year as well as devote time to commenting on key proposed regulations, all for the benefit of SAMED Members. As I retire, I welcome the new Chair Tanya Watson from Medtronic.

The Competition Commission's Health Market Inquiry is currently investigating the high cost of private healthcare in South Africa and has reason to believe that features of the sector prevent, distort or restrict competition. SAMED recognises that this Inquiry may have impeding implications to the Medical Device Industry. In response to this Inquiry and in line with our 4 year strategy, SAMED has put together a key committee dealing with all developments as well as oral presentations and submissions to Health Market Inquiry in response to allegations that Medical Devices are a cost driver in the high cost of private healthcare in the country. On the 24th of February 2016, the Committee presented an oral submission to the Health Market Inquiry Panel on the following key objectives:

Health Market Inquiry Committee

Medical Device contribution to SA cost of care-are Medical Devices really a cost driver?

Price Regulation will affect access to market and access of products for patients

The Medical Device Industry are price takers

Innovative medical technology reduces cost of care

Challenges faced by the Medical Device Industry

The committee is currently gearing up to present at the next set of hearings, which will keep in mind the need for industry to make a greater link between medical innovation, quality and long-term cost-effectiveness.

Marlon BurgessNHI

CommitteeChairperson

National Health InsuranceCommittee

SAMED recognises the impor-tance of the NHI in the near future to both our industry and the country. As such, SAMED established a committee dealing with all aspects of the recently released NHI white paper and is looking at other avenues within the National Health Insurance that we should engage in.

In early 2016, the committee hosted a very successful workshop with key experts including Dr Mark Blecher, Chief Director for Health and Social Development, National Treasury who briefed our audience on the NHI from National Treasury's perspective and the possible funding models.

SAMED is drafting a written submission commenting on the NHI white paper, focusing on the importance of innovative medical technologies, best practice procurement models for Medical Devices and the extensive human resource requirements needed to build a solid foundation for the system.

The Committee will be presenting its inputs at an NHI consultative forum with the NationalDepartment of Health in May 2016.

SAMED submitted extensive commentary to the draft amendments to Regulation 5 of the Medical Schemes Act and draft amendments to Regulation 8 of the Medical Schemes Act by mid-October 2015 and is awaiting developments here.

The Low Cost Benefit Option proposal, primarily Primary Care & Diagnostics in Design, was withdrawn in late 2015 as the benefit package was inconsistent with current clinical practice and national policies and SAMED commentary was instrumental ensuring that the views of the industry were heard.

Panel consisting of Mr Neil Kirby, Director, Werkmans Attorneys; Advocate Elsabe Klinck, Director, Elsabe Klinck Consulting; Dr. Rajesh Patel Head of Benefit and Risk, BHF and Dr. Chris Archer, CEO of SA Private PractitionersForum addressing questions from the audience at the NHI workshop.

16.

Tony Lowther OSIS Committee

Chairperson

OSIS is specifically involved in Elective Orthopaedics, Trauma and Spine, working closely with the South African Orthopaedic Association (SAOA). The Committee was revived by the request from the SAOA who asked for guidance on certain issues relating directly to their Association. The Committee

has subsequently engaged extensively with the Association around fair market value, venue vetting, and sponsorship to and for congresses as well as fellowships.

The Committee recently successfully presented on all these issues to the SAOA in April 2016. We are looking to further this engagement going forward.

Orthopaedic Special Interest Section (OSIS) Committee

Madeleine PearceRegulatory CommitteeChairperson

Regulatory Committee

The SAMED Regulatory Committee's diverse Mem-bership, from both Medical D e v i c e a n d I n - V i t r o Diagnostic companies, local manufacturers, represen-tatives of large multinational companies and smal ler businesses, distributors and consultants, requires that SAMED takes a balanced view i n d i s c u s s i o n s w i t h

stakeholders over matters impacting the Medical Device industry.

Strategic Focus

Our strategic focus for 2015 was to:

Pro-actively influence and drive for appropriate regulations by engaging with stakeholders

Provide SAMED Members/stakeholders with direct knowledge of industry and international trends and developments

Participate in the setting of standards in the health industry in general and the Medical Devices industry in particular, where required

2015 Highlights

2015 was a busy year for the SAMED Regulatory Committee, as a number of regulatory and related issues arose that will affect the Medical Device market in South Africa down the line. Notable among these are:

Finalisation of Bill 6 (legislation for regulation of Medical Devices) - now Act 14 of 2015, which has been published and signed and will come into effect when Act 72 is proclaimed. (Act 72 amended the Medicines and Related Substances Act 101 of 1965 to include a new Regulatory Authority (SAHPRA) which will include Medical Devices in its mandate)

1.

Publication of the second draft of Medical Device regulations for public comment

2.

Publication of a proposed draft guidance document for the reuse of single use devices by a SABS Technical Committee

3.

Another High Court judgement on the jurisdiction of the Medicines Control Council over Combination Medical Devices

4.

In principle, SAMED is in favour of regulation because it will hold suppliers and users of Medical Devices to the highest standards and safeguard the well-being of patients. Over-regulation or inappropriate regulations, on the other hand, may discourage supply of Medical Devices to the health system in South Africa, which could adversely affect patients' access to care.

5.

Education and Stakeholder Engagement

Throughout the year the Committee presented at various forums to SAMED Members and other organisations spreading our message of appropriate, harmonised and implementable regulation for the Medical Device industry and explaining the outcomes of the public comments on proposed draft regulations. The year ended with a two-day Regulatory Workshop convened by SAMED in consultation with the Medicines Control Council. This well-attended meeting provided a forum for regulators and industry representatives to discuss the latest approaches to Medical Device regulation. The roadmap to regulation in South Africa waspresented by the Registrar of Medicines. Invited guests and speakers included the regulators from Ghanaand Nigeria as well as international experts in our field.

18.

Combination Medical Devices

Standards for Medical Devices

Two High Court rulings have determined that the Medicines Control Council does not have jurisdiction over the registration of combination Medical Devices (that contain a substance which may be a medicine in some contexts), if the product meets the definition of a Medical Device. In the light of the court declarations, SAMED met with MediKredit to ensure that NAPPI codes would be issued to Combination Medical Devices and met with the hospital groups to discuss the impact of the court rulings. SAMED also sought clarification again from the Registrar of Medicines. The outcome of this meeting is still pending.

SAMED voted against a draft guideline proposed by a SABS Technical Committee that directs how Medical Devices intended for single use may be reused. SAMED opposes any guidance that advises deviations from instructions for use provided by manufacturer. This raises issues of liability and patient safety.

International Harmonisation

Each year, the SAMED Regulatory Committee Chair participates on behalf of South African industry at the Asian Harmonisation Working Party. In 2015 there were in-depth discussions on software as a Medical Device, the increasing oversight over notified bodies for CE marking of products and the One Audit Program, where regulators share inspection activities. Other African states are also joining this forum of industry experts and regulators which demonstrates our region's commitment to harmonised regulation.

SAMED, via our Executive Officer, Tanya Vogt, is on the Board of the Global Medical Technology Alliance (GMTA), a forum of international trade Associations, who also give input to the International Medical Device Regulators' Forum (IMDRF), where standards of practice for regulation are decided.

The SAMED Regulatory Committee remains focussed on preparing the industry for coming regulation. We gratefully acknowledge the assistance of the large pool of volunteers and experts that provide SAMED Members with the best information for their own strategic planning as suppliers of Medical Devices in South Africa.

Status of Regulation of Medical Devices in South Africa as at the end of 2015

Medical devices (with the exception of electro-medical or radiation-emitting devices) remain unregulated. However, experts close to the Regulator advise companies to educate themselves on the coming regulations and implement Quality Management Systems that can readily be certified to ISO standards in order to qualify for the requisite business licences in future. The Department of Health has not yet committed to timelines for implementation.

Act 14 of 2015 in its final form had some changes to legislation that were not part of the public consultation process. Of concern is the inclusion of Medical Devices under the sections related to the Pricing Committee, which previously pertained only to medicines.

The SAMED Regulatory Committee provided detailed comments to the second draft of general regulations for Medical Devices in August 2015. It was particularly encouraging to see that the Department of Health has accepted that product registrations in certain accepted regulatory authorities will be taken into account and the approach of inspection/certification by third party Conformity Assessment Bodies, as seen in internationally harmonised Medical Device regulatory frameworks, has been accepted.

SAMED Regulatory Conference

19.

The importance of stake-holder engagement and planning is often overlooked by Associations. Discussions with stakeholders tend to take a react ive rather than proactive line. While, in many ways SAMED is now seen by stakeholders as a partner in their processes, we acknow-ledge that we need to do more to build and develop further

relationships with government, hospital groups, regulators and other key stakeholders. SAMED, as any other Association, has recognised the need for a comprehensive stakeholder strategy.

This year, as the Stakeholder Engagement Committee, the main objective was to identify key stakeholders and strategies to engage with each key contact. We have identified key stakeholders such as Funders, hospital groups, national and local government personnel, MediKedit, regulators, doctor societies and parliamentary bodies. As such, we have engaged with various government departments including holding a fruitful discussion with the Chair of the Parliamentary Committee on Health, Ms Mary-Ann Lindelwa Dunjwa around key challenges our industry is currently facing. This meeting resulted in the agreement by both parties to hold quarterly meetings to discuss issues facing our industry and to clarify any questions the Portfolio Committee may have for us.

We also were successful in securing the Minister of Health, Dr Pakishe Aaron Motsoaledi for an interactive and engaging breakfast briefing with our Members on the issue of NHI.

This meeting is just the beginning of a host of engagements this Committee intends to implement. In this regard, we look forward to a productive and exciting 2016! I would like to thank the entire Committee for their tireless hard work this year.

Stakeholder EngagementCommittee

Jeffrey Hampton StakeholderCommittee

Chairpersonl

Our Executive Officer, Tanya Vogt and SAMED Board Member, Marlon Burgess with the Honourable Minister of Health, Dr Pakishe Aaron Motsoaledi

Fathima MasoomTransformation

CommitteeChairperson

Transformation Committee

In 2015 the key focus has been o n e d u c a t i n g S A M E D Members on various aspects regarding the new B-BBEE code. In particular, the sessions covered in the October 2015 trans format ion Member meeting were very informative and well received. 2015 also saw the commencement of the collaboration between CSIR and SAMED to make the

CRICE training available to nursing practitioners engaging in post-graduate diploma in Infection Control. This collaboration has been extended in 2016 and continues to add value to nursing practitioners.

A primary focus in 2016 is to assist SAMED Members to expand their vendor database to include B-BBEE level 1 to 3 vendors within their supply chain. Importantly, the goal is to align such expansion with another key SAMED mandate, which is to grow the infrastructure, resources and supply chain to support the growth of the device industry in South Africa.

To this effect the transformation committee has organized a B-BBEE Vendor Exhibition that took place on 21 April 2016. The event is being planned and executed in collaboration with Masoom Medical Sales Representative Learnership students and thus addresses elements of the B-BBEE Procurement Pillar as well as the Skills Development Pillar.

SAMED Transformation committee via the learnership students have sourced, vetted and briefed vendors in key areas of the supply chain. The event will be the first speed-networking event arranged by SAMED and is also the first Eco-Friendly organized event. Another focus, in light of recent tension around racial intolerance, is on Cultural Diversity. A keynote speaker addressed SAMED Members around matters of tolerance linking business viability and sustainability to such matters in 2016.

20.

Malan de Villiers MDMSA

Chairperson

Two MDMSA Management Committee members Mr Anton Coetzee and Ms Simone Rudolph, flying the MDMSA flag at Arab Health in Dubai

The dti has also begun to motivate to the National Department of Health to apply local preference in certain government tenders, which is seen as a huge win for our industry.

We are acutely aware of the fact that we need as many of the local manufacturers as possible to become Members so as to strengthen our standing when lobbying for a greater share of the devices business in South Africa. We have prepared a business plan, which forms the basis of our application for assistance from the dti. This will now be progressed with dti and we will hopefully qualify for funding and export exhibition support in 2017. Funding will also be used to increase our Membership.

The new South African device regulations will come into force shortly. MDMSA commented on the draft regulations. The final legislation will hopefully incorporate aspects of our submission. We have looked at ways in which we can bring down costs with respect to ISO13485 accreditation for our Members. A local auditing capability would go far in helping in this regard.

Our financial model presently is that Membership fees is aligned with that of SAMED and is managed by SAMED. The support from SAMED's administrative office has been outstanding.

It will be for the new management committee to decide whether this is still our preferred way forward.

We held our annual AGM in April 2016 and a new management committee has been elected. We congratulate the new committee on their election and hope that we can build fruitfully on the progress of the past year.

May the local industry grow from strength to strength!

Medical Imaging Systems Association (MISA)Report Back

As the MISA (MedicalImaging systems Association) our main objectives are to promote the interest of our imag ing Members . Our Members are pr imar i ly

involved in the Medical Diagnostic Imaging devices, which are regulated by the Radiation control board via the Hazardous substances act. Over the past year, MISA sponsored a number of Radiographers via their Association SORSA (Society of Radiographers of South Africa) to attend their congress which occurs in combination with the RSSA (Radiological Society of South Africa), via an indirect sponsorship method, whereby SORSA maintained the decision on which students received the sponsorship. This provided an immense opportunity for students to receive further training and experience on new technologies and innovations within our industry.

MISA also presented at the SAFHE/CEASA (South African Federation of Hospital engineers/Clinical Engineering society of South Africa), which provided a platform to highlight the Marketing Code and included a discussion on issues surrounding medical products in an unregulated vs regulated environment.

A strategic objective for MISA this year was engaging with stakeholders including regular interaction with our regulator and customers via RSSA on issues relatingto demonstration equipment licensingand regulatory updating of requirements.

William Hodson MISA

Representative

22.

The Department of Trade and Industry (dti) over the last year has recognised the importance of the local Medical Device manufacturing industry. The dti has engaged intensively with our Association to better understand the needs of our sector. As such, a major achievement this year saw the establishment of a dti led Forum consisting of dti, National Department of Health, SABS, SAMED and MDMSA. This Forum will continue to meet quarterly to iron out any challenges each stakeholder is facing, thus strengthening our partnerships.

MDMSA Members also took part in a very successful dti funded Arab Health Trade Mission, which assisted Members in exposing their products to the Arab Market.

I wish to thank Wayne Flowers from AEC-Amersham, who is retiring this year for his unyielding commitment to our Association as a Member and past Chairperson. We wish him well. As this is my last year as MISA Chairperson, I would like to thank my fellow MISA Members for their support over the last 4 years, without which none of our many achievements would be possible.

Robyn HowesSALDA

Representative

Southern African Laboratory Diagnostic Association (SALDA)

The Southern African Labora-tory Diagnostic Association is a body that represents laboratory medic ine in Southern Africa. It is a single voice around IVD's. It is a

collaboration of multinational and local companies which distribute In Vitro Diagnostic tests. We are constantly identifying the value of the IVD Industry to keep our market relevant and to promote cost savings through new and innovative technology.

This year saw many achievements for the Association, most importantly the increase in our stakeholder engagements with regulators, government departments, NHLS and SAMED. Our African relations grew through our partnerships with the African Society for Laboratory Medicines (ASLM) and Pan African Harmonisation Working Party (PAHWP). SALDA also aims to ensure all Members adhere to ethical marketing practices through our Association with the Marketing Code Authority.

In terms of the regulatory process, we had extensive input into Medical Device and IVD regulations and guidelines and were pleased to see the improvements in the NHLS HTA process.

SALDA also participated in a South African Market survey for IVDs which has global relevance through CIP and EDMA Membership, and this year we saw the survey grow in participants.

We still face challenges in terms of harmonized policies around Point of Care, maintaining momentum and impact beyond the marketplace, showing tangible value to the businesses of our Members and unifying our stakeholders within the

pillars of pathology. This year we are looking to address these challenges through the following activities and principles:

Planning of strategy sessions to identify SALDA's key focus relating to NHI, over the next 5 years

Revival of the "Market Value" portfolio, and identifying specific activities needed to achieve

Improving communication platforms to deliver information to the Members

Create awareness of the benefits of SAMED Membership through SAMED

Promoting SALDA as an outcomes driven Association that remains relevant in the market.

To encourage active participation in activities within the SALDA Membership through the influence of the "Market Value" portfolio

To uphold good governance within SALDA, Exco Members and meetings

We are looking forward to a successful year!

Compliance and SAMED

SAMED's Code of Business Practice Update

SAMED promotes and encourages among Members, ethical principles and practices, and to this end has published a Code of Business Practice. SAMED is also a signatory to the SA Code of Practice for Marketing of Health Products. These Codes are an essential guide and support for SAMED Members in their business interactions with their customers.

SAMED is constantly ensuring that the Code of Business Practice is evolving and changing to incorporate the changes within the industry and South Africa.

SAMED is currently developing a guideline for the utilization of nursing professionals by SAMED Member companies as independent contractors or as employees. On the 17th of March 2016, SAMED along with the expertise of Advocate Elsabe Klinck held an informative and interactive workshop with Members who contract with private nurses. This workshop included very clear guidelines that outlined thefollowing:

24.

The guidelines will be finalised this year.

The Marketing Code Authority (MCA) is a voluntary Association for the self-regulation of companies that market health products in South Africa. It is a condition of Membership that all ordinary SAMED Members, are also Members of the MCA and are bound by the Marketing Code for health products.

This year saw significant changes in the MCA code to align with changes in the international market as well the learnings in the South African health products' industry. SAMED has also taken an active role within the Marketing Code Authority (MCA), and has representation on both the MCA board of directors and on the Code Technical Advisory Committee (CTAC). We are currently looking at ways the MCA can continue to provide SAMED Members value, and how the MCA can improve its enforcement and sanctioning capabilities.

Marketing Code Authority Update

What is advisable for companies to include in their contract with private nurses

Informed consent between the nurses and their patients

Clarity on coding, coding authorities and reimbursement of services

SAMED Members discussing ethical practices when contracting with private nurses.

In total there have been 12 complaints

heard by the MCA since inception with one

pending in 2016

SAMED’s Offerings

Upon Membership, Medical Device companies automatically become part of a larger Association that has the expertise and commitment to advocate for and protect the rights of its Members.

Members have access to regular Member meetings and workshops on a range of industry issues enabling Members to connect with other individuals and businesses and benefit from opportunities.

SAMED engages with policymakers, regulators, politicians, doctor societies, Funders and international organisations to develop and propose patient-centered policies that enable people to live healthy and productive lives and provide solutions that significantly drive the productivity and efficiency of healthcare systems.

SAMED also subscribes to the government gazette and tender bulletin and the parliamentary monitoring group and collects and provides Members with privileged and reliable data on a wide variety of issues thereby enabling them to make informed business decisions.

Networking and workshops

Advocacy and Relationship with key stakeholders

Our Executive Officer, Tanya Vogt and Dr Mzukisi Grootboom, Chairperson of the Board of Directors, South Africa Medical Association

25.

Industry Related Information Updates

In the News - Members enjoy regular, industry-related information gathered from numerous sources, including government (PMG, legislation) and private sector.

News Roundup - The SAMED News Roundup supplies our Members with the latest local and international news on Medical Devices and Diagnostics and the healthcare environment in South Africa.

Members have access to advice and support regarding the regulation and reimbursement of devices, both abroad and locally.

Members have access to contacts across government healthcare departments, tender boards, private sector health care groups and health care professionals.

Members benefit from incoming distributor and tender enquiries (local and overseas), information requests and trade delegation requests.

International Linkages

Trade Delegations

SAMED keeps Members abreast of global best practices with their linkages to GMTA, AHWP, Eucomed and Advamed.

Hosting both incoming and outgoing trade delegations upon request.

Flagship Event: Annual Conference

We bring together stakeholders in order to discuss trends, issues and opportunities and each year SAMED organises an annual conference to discuss and engage with stakeholders on common topics of interest. This is SAMED's flagship event.

SAMED is supportive of harmonization of standards and regulatory requirements within the area of Medical Devices manufacture and supply; and to this end has an Association with other stakeholders and international agencies, including: CTAC (Code Technical Advisory Committee for the Marketing Code), ITG (Internal Task Group), SHIP (Strategic Health Innovation Partnership), Non-Communicable Disease (NCD) Alliance, PAHWP (The Pan-African Harmonisation Working Party), AHWP (The Asian Harmonisation Working Party), GMTA (Global Medical Technology Alliance), MedTech, WHO (World Health Organisation) and AdvaMed

Below are a few of our additional stakeholders:

26.

Company Representatives in the Clinical Environment (CRICE)

CRICE is a SAMED initiative that is the industry standard for professionals representing Medical Device companies in the clinical environment and is administered by Masoom Training Solutions.

The CRICE initiative is still going strong. SAMED and Netcare have collaborated to establish the CRICE course as a pre-requisite for entry for company representatives into Netcare facilities. The Netcare requirements have been incorporated into the CRICE programme. Upon successful completion of the course, company representatives are issued with a CRICE Access Card.

CRICE Statistics:

4 Sectors: Pharma, Device, IVD and Logistics

Almost 8000 CRICE AccessCards issued and counting

357 Companies enrolled

SAMED Activities 2015 / 20106

SAMED's Advocacy

SAMED actively sought Member's views and advocated on behalf of its Members on the following:

Commented on Regulation Gazette No. 10177: Skills Development Act (97/1998): "Proposal for the new National Skills Development Strategy (NSDS) and Sector Education and Training Authorities (SETA) landscape within the context of an integrated and differentiated post -school education and training system (NSLP -2015)”

Provided an extensive submission on General Regulations Relating to Medical Devices and in Vitro Diagnostic Medical Devices (IVDS) as Contained in Government Notice R665, Government Gazette #39048, Published on 31 July 2015

Wrote a submission with regards to the governance, administration, effectiveness and efficiency of the HPCSA

Commented on 8.01: General guidelines for Medical Devices and IVD's

Compiled a written submission on price increase methodology,(GG No 38988, 13 July 2015)

Provided comments on proposed OHSC Norms and Standards Regulations

Gave commentary on the CMS' proposals regarding Low Cost Benefit Options and draft amendments to Regulations 5 and 8 of the Medical Schemes Act

Made a number of submissions and presented an oral submission to the Health Market Inquiry Panel on the high cost of private healthcare in South Africa

Updated and submitted its position on Single Use Medical Devices to the SABS, NDoH and the

Engaging with Key Stakeholders

SAMED continuously engages with the Marketing Code Authority and is an active Member of the MCA Code Technical Advisory Committee, attending regular meetings throughout the year.

SAMED presented to and / or met with a number of doctor societies on key issues impacting our industry i.e. South African Heart Association (SAHA); South African Society of Anaesthesiologists (SASA), South African Society of Cardiovascular Intervention (SASCI), South African Orthopaedic Association (SAOA) and the Society of Neurosurgeons of South Africa (SNSA).

We represent Medical Device Companies in the Industry Task Group, which brings together Industry Associations and Medicines Control Council in a quarterly Forum.

SAMED participates in a dti led stakeholder Forum consisting of SABS, NDoH, the dti and Medical Devices Industry addressing concerns from both the Medical Devices Industry and the NDoH relating to issues experienced with the SABS services and other related sector issues.

SAMED is continuing its advocacy work through its strategic engagement with the Department of Science and Technology (DST). Our ExecutiveDirector, Ms Tanya Vogt was nominatedby the DST to represent them on

27.

Strategic Health Innovation Partnerships SHIP steering committee. SHIP recently reviewed and decided to continue supporting a ground-breaking study into finding a 'home grown' vaccine for HIV.

The National Treasury is currently embarking on a centralised procurement mechanism where they will procure all essential devices for government hospitals. For the first time in SAMED's history, we were approached by National Treasury in assisting them to draw up an essential equipment list for government hospitals.

SAMED has engaged with NDoH and National Treasury on an alleged blacklisted supplier obtaining a national tender. We are awaiting the outcome of their investigation.

SAMED sits on the NAPPI Advisory Board Working Group, which has numerous engagements with MediKedit with regards to the issuing of NAPPI Codes for Combination Medical Devices. SAMED has met with some success in this regard, with MediKredit agreeing to issue NAPPI codes on combination Medical Devices without MCC registration.

SAMED met with the Council of Medical Schemes on the need for a Centralised Health Technology Assessment Body.

SAMED attended a number of events held by key stakeholders including; the HASA conference, Annual DHL Life Science & Healthcare Conference and a seminar on "Managing Infection Control", Business Matching session with the Malaysian medical glove manufacturers and the 20th AHWP Annual Meeting in Bangkok amongst others.

SAMED met with Discovery to better understand their home care and distributor business and potential impact for Members. Discovery wants to ensure their patients get best care out of hospital so they have employed nurses, is a type of franchise system.

SAMED on behalf of MISA was invited to be part of the TUT Electrical Engineering Academic Advisory Committee with a view to bring positive change to students Medical Device companies employ as engineers.

SAMED has met with Dr Desmond Johns from the Institute of Regulatory Science with the hope to develop a future partnership with the Institute.

SAMED continues to engage with Gauteng Health on the issue of outstanding payments to our Member companies. After an extensive Member survey with regards to outstanding payments, SAMED has met with Dr T.E. Selebano (Head of Department for the Gauteng Department of Health) and Ms Babita Deokoran (Chief Finance Director for the Gauteng Department of Health) regarding this issue and is looking to extend this engagement all provincial departments of health.

SAMED is on the Board of the Global Medical Technology Alliance (GMTA), a forum of trade Associations, who also give input to the International Medical Device Regulators' Forum (IMDRF), where standards of practice for regulation are decided and regularly attends GMTA board meeting and general assemblies.

Knowledge Sharing with the Local and International Community Our Executive Officer, Tanya Vogt represented SAMED's views at the 2015 Global MedTech Compliance Conference (GMTCC) on a panel discussing "Direct and indirect sponsorship of HCPs to third-party organized conferences: Global trends and challenges" Direct sponsorship is not allowed in certain countries. In light of this fast-changing environment, the discussion examined the subject to try to identify the challenges ahead, when direct sponsorship may not be possible anymore. Tanya indicated that there is a long history of direct sponsorship in South Africa, many doctors expect it. SAMED anticipates that it would take some time to phase this out if agreed to do so, with much engagement required with our Members and the doctor societies.

Tanya Vogt, SAMED Executive Officer, presenting her views on the direct and indirect sponsorship of HCPs at the 2015 Global MedTech Compliance Conference

28.

SAMED participated on a panel at the MCA training seminar on the 28th of May.

On behalf of MISA, our Executive Officer Tanya Vogt, presented on the SAMED Code of Business Practice at the SORSA Annual Conference.

At the South African Federation of Hospital Engineering (SAFHE) and Clinical Engineering Association of South Africa (CEASA) in Association with SBS Conferences 11th Biennial Conference & Exhibition, SAMED was invited to present on our submission on the draft Medical Device Regulations and the SAMED Association.

Through the OSIS Committee, SAMED presented to SAOA on fair market value, venue vetting, and sponsorship to and for congresses as well as fellowships.

SAMED presented at the SALDA AGM this year with regards to the benefits of belonging to SAMED and our 2015 achievements.

SAMED was asked to write a number of articles for various publications, including Clinica on SAHTAS, HTA and regulatory matters in SA; an editorial for the HPCSA's newsletter on the danger of re-using single use devices and our Code of Business Practice with Healthcare Professionals as a way for them to avoid unethical practices; and Ms Tanya Vogt was interviewed late last year by Pharma Boardroom on the recent regulations surrounding the Medical Device industry in South Africa, why South Africa remains the hub and the major gateway to Africa for Medical Devices and In Vitro Diagnostics and talks about recent focus by government on supporting local manufacturing.

SAMED presented at the SAPRAA quarterly meeting on the Latest Gazetted Regulations/MCC guidelines: SAMED Concerns/comments.

The Annual SAMED salary survey is a major value add for SAMED Members. Subsidised significantly by SAMED, it assists Members in making key decisions around remuneration and employee benefits. This past year, 28 Members participated.

SAMED Salary Survey

Remuneration or Employee Benefit

Major Trends in the Industry

Actual SalaryIncreases Granted

SAMED Members and survey participants granted average basic salary increases at approximately 2.71% above the average inflation rate of 4.39 % for 2015. Salary increases in the industry sector typically ranged from 6% to 9%, with the weighted average being around 7.2% for the overall workforce. This aligns with current nat iona l t rends in sa l ar y m ove m e n t s . T h e g e n e r a l prediction is that increases for 2016 will be between 6% and 7%, still above inflation which is expected at 5.1%.

Average ProjectedIncreases

Standby Allowances

Emergency call-outAllowance

Premiums Paid to Attract Affirmative Action Employees

Working Hours

94 % of organisations intend awarding increases within defined ranges for the next period under review. The majority of SAMED survey participants will keep their projected salary increases for 2016 very stable and in line with the 2015 increases.

A significant number of or-ganisations have introduced policies permitting f lexible working hours (flexitime) and working from home.

36% of organisations pay an allowance to staff that are required to be on standby (i.e. available for call-out) during off-duty hours. Note that this allowance is separate from the amount paid (usually overtime pay) when a call-out is actually required.

8 % of participating organisations pay an emergency call-out allowance.

16% of organisations acknowledge having to pay premiums over p re sen t marke t r a t e s o f remuneration to attract suitably skilled staff to meet affirmative action targets.

Some key findings for 2015 include:

30.

SAMED hosted a number of key events, Member meetings and workshops throughout the year including:

Three sold-out Reimbursement & HTA Workshops in July, September and November. These workshops provided valuable grounding in the discipline of HTA & HE and as importantly, how to successfully integrate business, marketing & reimbursement strategies for Medical Devices.

A general Membership workshop with the Discovery Health Surgical Risk Management and Clinical Policy Unit teams in early November interacting with them on general issues and others important to their businesses, as well as to learn first-hand about Discovery Health initiatives underway.

A Special Member's Meeting to discuss the MedTech proposal to prohibit direct sponsorship of health care professionals to third party organised events.

Member Meeting on a General Update on Medical Device Regulations - Africa, South Africa and ISO 13485 with Jane Rogers (Strategic & Operational Business Consultant at Jane Rogers Strategic Healthcare Solutions) presenting on "Best practices for Medical Device Regulatory Oversight" amongst others.

Special Workshop on Single Exit Price Methodology and the Relationship between the pricing regulations and Medical Device regulations

The Transformation Committee hosted a General Member's meeting on the latest B-BBEE Codes. Buhle Moyo founder of People Developers Network Enterprises spoke to Members on how to monopolise on the Enterprise and Supplier development pillar. Ismail Laher from Norton Rose walked us though important changes in the code impact on a practical level and lastly Justice Malala gave us an insightful overview of the political landscape.

BSI (British Standards Institution) in conjunction with SAMED and MDMSA hosted a breakfast with keynote speaker, Mr Richard Tully, Technical Team Lead, ISO 13485 & Product Specialist - BSI.

With over a 150 delegates, SAMED hosted its most successful Annual Conference to date. Day 1 allowed delegates to discover how national government, Funders, professional Associations, private and public hospitals, coding specialists evaluate Medical Devices: "Medical Devices and Health Technology Assessment: Resolving the Puzzle."

The second day titled "Compliance and Ethics: Central to your business or on the periphery?" informed delegates on the views of key Opinion Leaders from national government, consultants, industry, doctor societies, HPCSA, international med tech Associations on the importance of ethics and compliance and emerging trends impacting the Medical Device industry in South Africa.

A successful Medical Device and IVD Regulatory Conference with over 200 delegates. This two day conference aimed to raise awareness and understanding of the Medical Device Regulatory Framework, to prepare companies, service providers and government for the implementation of the regulations, as well as to obtain input from all stakeholders on the practical implementation of both the regulations and guidelines.

Two successful Regulatory Workshops were held providing companies with practical guidance on how to prepare their organisation for regulations. The first workshop focused on key reference documents and understanding the law surrounding regulations. The second workshops focused on implementing a Quality Management System within your company.

A workshop for Members on NHI with a range of informative and insightful speakers including Dr Mark Blecher, Chief Director for Health and Social Development, National Treasury, Mr Neil Kirby, Director, Werkmans Attorneys; Advocate Elsabe Klink, Director, Elsabe Klinck Consulting; Dr Rajesh Patel, Head of Benefit and Risk, Board of Healthcare Funders; Dr Chris Archer, CEO, SA Private Practitioners Forum and Mr Marlon Burgess, CEO, MDG Solutions.

SAMED's 30 year celebration that kicked off with a trip down memory lane with previous long standing SAMED board Member Mike Howe-Ely.

SAMED Events 2015/2016

31.

At the request of our Members SAMED organised a General Members Meeting around how your company can survive during these tough economic times. These economic times are amplified by an ever changing currency, the refusal of medical schemes to allow companies to increase their prices and a changing health sector. SAMED secured three exceptional speakers including Advocate Elsabe Klink, Elsabe Klinck Consulting, Ms Mariné Erasmus, Head of the Health Economic Unit, Econex and Ms Lullu Krugel, Partner and Chief Economist, KPMG South Africa.

For the first time in SAMED's history along with 120 SAMED Members, SAMED hosted the Honourable Minister of Health Dr Pakishe Aaron Motsoaledi for a breakfast briefing to discuss the National Health Insurance and the future of healthcare reform in South Africa.

32.

About the Medical Device Industry

We are often as industry asked why Medical Devices are unique within the overall healthcare sector. Below is a short table explaining the differences between devices and pharmaceuticals.

South Africa's domestic Medical Device industry remains underdeveloped, with imports catering for 76% of the market by value. According to a report done by Epicom Business Intelligence, the South African Medical Device market was estimated at USD1.1bn in 2015 and ranks among the top 30 largest in the world. Wesgro estimated the market to grow by a CAGR of 7.7% between 2013 and 2018, driven mainly by the development and upgrade of hospitals through public-private partnerships. In the Council for Medical Schemes 2013/2014 port, wherein Medical Devices are stated to constitute only 7% of total hospital expenditure, reported under consumables and equipment.

This is a highly innovative industry, on average devices are superseded by new / improved devices within 18 - 24 months. This means that certain devices have a much shorter life cycle (2 - 4 years) than pharmaceuticals, within which the research and development costs involved have to be recouped. The short life cycle involved in the development / innovation of Medical Devices ("fast followers") is a further factor ensuring that barriers to entry in the Medical Device Industry are relatively low and stimulates competition.

Medical Device Industry is characterised by so-called "value adds" which are unique to the Industry, the cost of which are borne by the companies themselves and are often 'unacknowledged'. Medical Device companies often ensure training, retraining and skills development of Healthcare Professionals and other users of devices to ensure correct use of devices (at least R31.7m for 47

companies participating in a KPMG 2014 survey); as well as absorb the cost of delivery of products used in emergency cases e.g. trauma surgery due to accident; and the cost of keeping stock, cost of maintenance and support.

The Medical Device Industry is by and large unregulated, which poses a serious concern to patients, SAMED and its Members. This means that fair competition, specifically on price for quality products, is negatively affected, and leads to the use of substandard quality products (which are imported at a fraction of the cost of good quality products), thereby not only increasing costs in the long run owing to the use of less effective, substandard products but also potentially endangering patients' lives. The introduction of a regulatory regime ensuring that all Medical Devices and persons importing, manufacturing and selling such devices need be registered and/or licensed, will greatly aid competition in the Medical Device industry as device users will be able to accurately gauge the quality, safety and efficacy of a particular device particularly when comparing devices.

Devices

Effective by mechanical and/or electrical action

Outcomes often depend on surgical skill

Innovation cycle (2-4yrs)

Lower barriers for competitive product entry - "fast followers”

10,000s products

Proliferation of versions, features, accessory combinations

HTA for Medical Devices on recently started

Good quality scientific data often not available - regulatory environment

Increased variation in treatment pathways between countries

Comparatively low returns

Pharma

Effective when absorbed and metabolised by the body

Operator skills rarely relevant

Long product life cycles (10-20 yrs)

High barriers to entry and patent exclusivity

Few 100 products

Limited variation of dosage or form

HTA processes for drugs long-established

Good quality scientific data usually available due to different regulatory requirements

Compraratively higher returns

33.

Innovative Medical Devices brings Valueto Healthcare:

South Africa Institute for Advancing Sciences Facility Overview

SAMED Members Making a Difference

On November 12th 2015, Boston Scientific cut the ribbon to unveil its new Africa training facility. The 560 m² Johannesburg Institute for Advancing Science (IAS) represents Boston Scientific's commitment in Africa to improve patient outcomes. As life expectancy increases in the African subcontinent, an increasing number of patients with significant co-morbidities will require procedural interventions for an improved quality of life and/or therapeutic cure. The Johannesburg IAS has been designed to train health care professionals, to meet these growing needs by providing a safe training environment that optimizes their procedural skillsets and knowledge required to make appropriate clinical decisions in complex cases.

Through collaboration with African physicians, African medical societies, internationally renowned physicians, and international medical societies, the IAS will provide an unparalleled 21st century educational experience for all health care professionals.

The facility consists of (3) state-of-the-art training laboratories and (3) conference rooms to facilitate understanding across many systems of the human body including (but not limited to): cardiovascular (coronary, structural heart, electrophysiology), peripheral vascular, gastroin-testinal / hepatobiliary, urologic, gynecologic, pulmonary, and neurologic (neuromodulation). Live-streaming capabilities and global interconnectivity with our 6 sister IAS facilities will provide extraordinary access to world thought leaders and pioneers in medicine.

From left to right: Supratim Bose, EVP & President, AMEA: Dr Joe Phaahla, Deputy Minister of Health: Ruwaida Shaikh; BSC South Africa Country Director

Boston Scientific’s Training Room

34.

Redoing the Children's Ward at Dr. George Makhari Academic Hospital 17 December 2015

The new Children’s Ward

Five very enthusiastic people from Acelity got together to add brightness and cheerfulness to the Ortho Children's Ward at Dr. George Makhari Academic Hospital. The team was helped enormously in putting up the very difficult task of wallpaper and decorating the reading and play area. Acelity also donated gifts, educational toys and books.

Boston Scientific Working in Collaboration with Project HOPE

Boston Scientific is working in collaboration with Project HOPE, a global health education and humanitarian assistance organization, to assist with the screening of South Africans for diabetes and hypertension. Project HOPE is one of the largest non-governmental organizations providing screenings as part of the National Department of Health's goal of screening eight million South Africans for non-communicable diseases. The country is second only to Nigeria among African nations with the highest rates of adult diabetes1 and the world's highest rate of high blood pressure among people over 502.

From left to right: Project HOPE Global Director Dr Thomas Kenyon: Boston ScientificAMEA Region President Supratim Bose, Deputy Minister of Health: Dr Joe Phaahla.

36.

Ordinary Members:

SAMED New and Existing Members

3M South Africa (Pty) Ltd

Abbott Laboratories S.A. (Pty) LtdAdcock Ingram Critical CareAEC-Amersham (Pty) LtdAffordable Medical (Pty) LtdAgfa Healthcare South AfricaAHG Health Solutions (Pty) Ltd Akacia MedicalAmayeza AbantuAngio Quip Medical Supplies (Pty) LtdAriste Health (Pty) LtdArjo Huntleigh Africa (Pty) LtdAtomo Australia (Pty) LtdAuckland Orthopaedics (Pty) LtdAxim & Marcus Medical

Bausch & LombB Braun Medical (Pty) LtdBard MedicalBaroque Medical (PTY) LtdBeier Drawtex HealthcareBCC Pharmaceuticals Pty LtdBD (Pty) Ltd Bidvest Medical BiotechAfricaBiotronik SA (Pty) LtdBliss Medical (Pty) LtdBMK OrthopaedicsBSN MedicalBMG Orthopaedic Solutions (Pty) LtdBone SABoston Scientific (SA) (Pty) LtdBrittan HealthcareBrowning Surgical CC

CareFusion SA 319 (Pty) Ltd.CE MobilityCentre for Tissue EngineeringClinipro (Pty) LtdColoplast SA

Condor Medical Africa (Pty) LtdCossni Medical (Pty) LtdCovidien (Pty) Ltd C-Therm Africa (Pty) Ltd

A

B

C

Dräger Medical South Africa (Pty) Ltd

Edwards Life SciencesEQOS TechEndoAfrique (Pty) Ltd

FS & NCP Medical Agency CC

D

E

F

G E HealthcareGabler Medical (Pty) LtdGlaxoSmithKlineGlobus MedicalGrobir Medical Supplies

HemoCue SA (Pty) LtdHeraeus South Africa (Pty) LtdHartmann Vitamed Hutz MedicalHaylard Health

Imvula Healthcare Logistics

Jalo EnterpriseJohnson & Johnson Medical

Karl Storz Endoscopy (South Africa)(Pty) Ltd Kunene Health Care (Pty) Ltd

G

H

I

J

K

39.

Langamedics (Pty) LtdLifeAssay Diagnostics (Pty) LtdLitha MedicalLinette Bowen Agencies CC

M & L Medical Suppliers CC (Viva Line)Malachite Medical (Pty) LtdMaleho Medical SuppliersMacromed CCMaquet Southern AfricaMDG Health Solutions (Pty) LtdMedhold Medical (Pty) LtdMedical International OrthopaedicsMedtronic Africa (Pty) LtdMeril SA (Pty) LtdModiro Medical (Pty) Ltd

Neurophysics (Pty) LtdNuangle Medical (Pty) Ltd

Obsidian Health (Pty) LtdOmniMed (Pty) LtdOrthomedics PharmaceuticalsOrtho Sol DevelopmentOrtho-Xact (Pty) LtdOtto Bock South Africa

L

M

N

O

Paragmed (Pty) LtdPerryhill International (Pty) LtdPhilips South Africa Commercial (Pty) LtdPRISM Inter Africa ccProfessional OrthopaedicsPrometheus Medical Africa

Respitek (Pty) LtdRoche Products Pty Ltd - Diagnostics DivisionRollybrush SA (Pty) LtdRoth Medical (Pty) Ltd

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SA Biomedical (Pty) LtdSafmed (Pty) LtdSelective SurgicalSiemens Healthcare (Pty)LtdSleepNet BreatheNetSmith & Nephew (Pty) LtdSouthern Implants (Pty) LtdSouthern Medical (Pty) LtdSpecmed Medical Services Pty (Ltd)SteriTechStratmedStryker South Africa (Pty) LtdSurgical & Ophthalmic Supplies (Pty) LTDSupra Healthcare (Pty) LtdSurgitech (Pty) LtdSystagenix Wound Management SA (Pty) LtdSxS Surgical Solutions (Pty) Ltd

Teleflex Medical (Pty) LtdTorque Medical

Umsinsi Health Care

Vertec Scientific SA (PTY) LTDViking Medical & Surgical (Pty LtdVish Medical Supplies ccVitalAireVuwani Medical Solutions cc

Welch Allyn South Africa (Pty) LtdWerkomed (Pty) Ltd

ZimmerBiomet South Africa (Pty) Ltd

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SAMED

Associate Members:

CEASA NationalCSIR

DHL Supply Chain SA (Pty) LtdDI Medicine Regulatory Consultants cc

KD Consulting Pharmaceutical Solutions

Masoom Training SolutionsMC Pharma ConsultingMedical Project Dimensions (MPD)

Red Healthcare Learning

The Smart Group

Uti Pharma

The SAMED symbol was inspired by the country’s national flower, the King Protea - signifying growth, being proudly South African and the ability to thrive under adverse conditionsand a traditional African Gourd - representing nurture, sustenance and sharing forthe common good.

Executed in a contemporary style, we believe it communicates the elements oftogetherness, Ubuntu, networking, facilitating, mediating and caring, for which theassociation so proudly stands.

Association Members:

MISA (Medical Imaging Society of South Africa)SALDA (South African Laboratory and Diagnostics Association)

MDMSA (Medical Device Manufacturers Association of South Africa)

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