Slide 1

Unique Device Identification The Australian Experience

June 25, 2015

Kirk Kikirekov, Managing Director - hTrak

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Australian Healthcare • Public and Private Mix • Medicare – Universal healthcare system, partially funded by a 2% “Medicare Levy” on taxpayers • Tax incentives to take out private insurance for those people earning more than $90,000 (families

$180,000) through a surcharge levy if you don’t take out insurance. • 70% of Hospitals are Public • Most of the big teaching hospitals are public hospitals • There are some large private hospital groups in Australia, such as Ramsay Health Care and

Healthscope • Patients can elect to be treated as private patients in public hospitals • Funding of public hospitals is primarily the responsibility of the states. However, some federal funding

is also provided, depending the on the politics of the day!

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Medical Devices in Australia • Regulated by the Therepeutic Goods of Australia (TGA). • All medical devices listed on the TGA are required to be listed with a GMDN • Very small manufacturing base. Most product is imported from USA, Europe or Asia • Pricing of Implantable products is subject to a schedule within the Private Health

Insurance Act. It is regulated by a “Prostheses List”. • Each implant on this list is coded with a “Prosthesis Billing Code”. There are two prices

on the list – a Minimum Price and a Maximum Price. The minimum price is what the Health Insurers are obliged to pay. The co-payment is the difference between the Max and Min.

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Practical Issues • Manufacturers’ of orthopaedic implants (particularly trauma) struggle with understanding what is the

UDI? If an implant (screws/plates) are in a package where qty > 1, what is the base UDI?

• Many orthopaedic products are supplied “non-sterile” to hospitals. Products are sterilized by CSD departments, and put loosely into trays. However, it is still important that these type of items have a unique “DI” (if not full UDI). It is appropriate that a “virtual DI” is assigned to such items. The FDA GUDID database needs to be more flexible around these requirements

• Many manufacturers of implants are compliant with the outer packaging UDI’s, but not inner. Also patient stickers are often not compliant – this is very frustrating!

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Unique Device Identification A Global View

June 25, 2015

Jackie Rae Elkin, Medtronic

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International Medical Device Regulators Forum (IMDRF) UDI Work Group

IMDRF Guidance UDI for Medical Devices Final Version, December 9, 2013

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Country Timeline Standard Label Requirements Data Reporting

Japan 1999 GS1 & HIBCC Device Identifier, Production Identifiers to Unit of Use Level MEDIS: Reimbursement Ministry of Health, Labor and Welfare

Spain 2006 GS1 Device Identifier, Production Identifiers to Unit of Use Level Reimbursement SAS - Department of Health Andaluz

Turkey 2009 GS1 & HIBCC Device Identifier, Production Identifiers to Unit of Use Level TITUBB: Reimbursement SGK – Social Security Institute

India 2012 GS1 Device Identifier, Production Identifiers to Unit of Use Level Procurement Ministry of Health & Family Welfare

IMDRF Release 2013 GS1 & HIBCC Device Identifier, Production Identifiers to Unit of Use Level UDI - International Medical Device Regulators Forum (IMDRF)

USA Class III: 2014 Implants, LS/ LS: 2015 Class II: 2016 Class I: 2018 (DM + 2 years)

GS1 & HIBCC ISBT

Device Identifier, Production Identifiers UDI Database: Regulatory US Food and Drug Administration

Argentina 2014 - 2015 GS1

Device Identifier, Production Identifiers and Global Location Numbers (GLN). Track and Trace Implementation.

Database – Traceability ANMAT

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Argentina Traceability Project ANMAT Regulation on Traceability requires tracking and reporting from manufacture through the supply chain, into the hospital and to the patient. GS1 Global Location Number (GLN) is used for tracking movement locations. The Track and Trace implementation requires Serialization of all products listed in the implementation. Current Deadlines

February 2015 defibrillators/cardioverters, electric stimulators for cochlear hearing, intraocular lenses, cardiac pacemaker, breast internal prosthesis;

August 2015 vascular coronary endoprosthesis (stent), hip prosthesis, and column prosthesis.

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Country Timeline Standard Label Requirements Data Reporting

EU Delayed. 2015/2016 GS1 & HIBCC Device Identifier, Production Identifier to Unit of Use Level Eudamed Database: EC Regulatory

Canada 2016 GS1 & HIBCC To Follow IMDRF UDI

Turkey 2017 GS1 & HIBCC Device Identifier, Production Identifier to Unit of Use Track and Trace Implementation – Serialization?

UTS: Track all processes of import products from Customs to end customer

Japan TBD GS1 & HIBCC Device Identifier, Production Identifier MEDIS

China 2015 / 2016 ? International & National Device Identifier, Production Identifier to Unit of Use Level CFDA Database

Brazil TBD TBD To Follow IMDRF UDI

S. Korea TBD TBD TBD UDI

Singapore TBD TBD TBD UDI

Saudi Arabia TBD GS1 Track and Trace Implementation – Serialization? UDI

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EU Medical Devices & IVD Regulations Status: EC Proposal MD Regulation – Q3 2012 EC UDI Recommendation – April 2013 EC proposed regulation MD / IVDs - European Parliament & Council review Anticipate regulations to be adopted in 2015 Anticipate European Commission to release the Delegated Acts on UDI end of

2015 / beginning 2016 Ongoing Developments: Eucomed Task Force on the EU UDI Database (Eudamed) TTIP Negotiations - FDA shares GUDID technical documentation with EC

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CFDA UDI Rule Status: CFDA UDI Draft Rule in review. Will have a comment period after public release of the Draft Rule.

Continuing Discussion: Acceptance of global UDI standards and National Code CFDA to be issuing agency for National Code UDI database approach in China similar to that of US FDA. Use of GMDN and/or a National Nomenclature

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Turkey UDI Program TITUBB All reimbursable medical devices must be identified and marked. Approximately 2.5 million approved medical devices in the Turkish database. Development: MoH is working on a new project called UTS (product tracking system)

which will replace current system TITUBB. Main aim is to track products from manufacturing facility to end customer. Since September 2014, workshops with the industry to collect and give

feedback to build the new system. New system is planned for June 2017 go-live.

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Canada Status:

In the preliminary stages of considering how a UDI system may be implemented in Canada and will be developing a guidance document for industry over the next year or two. Implementation of any UDI-specific requirements would only be considered after stakeholders have had an opportunity to comment on the draft guidance document.

Expect alignment on IMDRF UDI framework. Health Canada is

very supportive of the use of global standards.

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Benefits of UDI Global Alignment Provides for more efficiency, accuracy and automation of capturing product

information in the global supply chain Provides better visibility of device supply and movement through the

healthcare supply chain to the patient Provides better global visibility to device adverse events and recalled devices Provides a betters means to perform postmarket surveillance globally Enables healthcare providers to auto-capture device information consistently

and accurately in electronic healthcare records Enables capture of accurate and consistent device information in device

registries globally

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Jackie Rae Elkin Global Process Owner - Standard Product Identification | Medtronic, Inc. Global Regulatory Affairs 710 Medtronic Parkway, LS 330 | Minneapolis, MN 55432 USA Office: 1-763-505-2575 Mobile: 1-612-801-6615 jackie.elkin@medtronic.com