Medical Devices and Regulations: Feedback from SAMED’s Meeting with Benguela EOH 27 February 2012

23 March 2011Madeleine PearceChair: SAMED Regulatory Committee

POSITION ON MEDICAL DEVICE REGULATION

SAMED strongly supports a legislative and regulatory framework to control the

manufacture, distribution and marketing of medical devices and in-vitro diagnostics (IVDs)

to ensure that South African patients have access to products that are safe, effective and

of good quality.

Previously…….

Act 72 of 2008

• Amended the Medicines and Related Substances Control Act 101 of 1965

• Introduced SAHPRA (the South African Health Products Regulatory Authority)

• Made provisions for the registration of medical devices and in-vitro diagnostics

…….. was never brought into law

Implementation of SAHPRA

• SAHPRA is not likely to be implemented in 2012• Cabinet decision Dec 2011:

– SAHPRA will be a Schedule 3A Public Entity– Medicines and Related Substances Amendment Act (Act

72 of 2008) will be returned to Parliament for an amendment to remove the definition of health product (“product”).

• Changing legislation takes time (>12 months)• With no enabling legislation, implementation of

SAHPRA cannot go ahead

Benguela Health

• Was brought in to handle the medicines backlog and design SAHPRA

• SAMED/SALDA worked on medical device regulations with BH in several workshops Jan-June 2011

• Project was put on hold – priorities such as NHI

Benguela EOH Project Team

• Benguela Health joined EOH• Continuation of work done with industry in 2011 and previous

years• Project secured renewed funding to complete SAHPRA project• In 2012, reports to Registrar of Medicines, Mandisa Hela, who

is in charge of delivering SAHPRA• Legislation update means that the Project Team will not

facilitate implementation of SAHPRA but will prepare everything needed to establish and run entity

• Target of end June 2012 to have all outstanding work completed and packaged for the Minister

Health Technology Department NDOH

• Sam Bakhane appointed as DDG• Terry Downes collating comments from

regulations pertaining to Act 101 published in July 2011

• Not likely to go any further• MAC _HT• Advisory Panel for regulation

Meeting Benguela/Industry 27 Feb 2012

PART A (All)• General feedback

– Act and amendments– Public Entity– Structure– Food– CAMS– New Project Team

• Medicines– EDMS– eCTD– Fees

• PART B (With core group of device industry players to pick up on the Act 72

device regulations)• Devices

– Regulations

Prepare all required to establish and run

SAHPRA

Deliverable:

new establishment must improve situation, must not be ambiguous, must not be subject to corruption -medicines, medical devices, diagnostics, food, complimentary medicine, cosmetics, African traditional medicines, disinfectantsCreate an Operating Manual for SAHPRA

A regulations document – general principles

• To support the coming amendment to the Act• Attempt to fix gaps in regulation before amended law

is enacted• Attempt to adapt medicines regulations and

guidelines for medical devices/IVDs• Cannot refer to international standards• Tighter regulation and in detail

– to prevent too many changes as DOH changes policy (politicians come and go)

• Offences and penalties are required

Discussion Points 27 Feb 2012

• SAHPRA Fees– no cross subsidisation from other regulated health

products categories– estimated 35 line items per product group for

registration/per fee payable

Discussion Points 27 Feb 2012

• Labelling– no special labelling for South Africa– international guidelines for device/IVD labelling– impact of supply if medicines labelling regime is

followed– medical device/IVD supply chain is different –to

whom are you directing labelling

Discussion Points 27 Feb 2012

• Authorised Representative– Manufacturer– Legal Manufacturer– Distributor– Agent

• Consider Medical Device supply chain• Multiple agents, retail

Discussion Points 27 Feb 2012

• Recalls• Field Safety Corrective Action• Considerations

– Role of the Regulator– Role of Applicant– Time frames

Discussion Points 27 Feb 2012

• Combination products guideline• Medicines Control Council approach vs

International approach

Discussion Points 27 Feb 2012

• User– Patient?– Health care practitioner?– Operator?

• Defined in the National Health Act– “user” means the person receiving treatment in a

health establishment, including receiving blood or blood products, or using a health service

Documents provided by SAMED

Guidelines on:• Establishment Licence• Product Registration• Medical Device Classification• Medical Device Labelling• Lodging a complaint for a Medical Device/IVD• Recalls and Adverse Events

Documents provided by SAMED

International references provided information on:

• Changes to Registration• Clinical Trials• Vigilance Reporting Requirements• Terminology differences for MDs (PIL, PI, IFU, User Manual)• Product evaluations• Differentiating handling of capital equipment vs other MDs• Implants• Custom made devices• Conformance Marking• Handling of Transition Period, Grandfathering• Quality Management Systems• Establishment vs device licence

Next Steps

• Meeting with core group 12 April• Regulations document review• Discussion on proposed fees vs service level

agreements vs capacity• Comments on GWP guideline due 30 March• Comments on amendment to Act 101 due 15

June 2012

Questions