Global Regulatory Update

Asia: IMDRF, HK, Malaysia, Korea ME: Saudi Arabia America’s: accepting audit reports EU: legislative update ISO 13485:2014, EN ISO 13485:2012

Hong Kong Round table debate – March 2012

P

D C

A

AHWP – organisation refreshment • Association of Authorities legalised: AHWP ALS • New leadership

Chair: Kingdom of Saudi Arabia Co-chair: Chinese Taipei (REG) & Lindsay Tao (IND)

Technical Cie: Singapore, Saudi & Ming Tanakasemsub (IND) • WG1 pre-market / CSDT - Singapore & Singapore • WG2 PMS / Vigilance - Hong Kong & Hong Kong • WG3 QMS - Saudi & India • WG4 QMS auditing - Saudi & South Korea • WG5 Clinical - Singapore & India • WG6 Training - Singapore & Hong Kong • Nomenclature - China & China

• New member: Kuwait

2

AHWP and GHTF / IMDRF

• AHWP Workgroups are endorsing and improving GHTF guidance – step by step

• GHTF last chair is Japan • GHTF last conference Nov 2012, host: AHWP • IMDRF (GHTF5 + Brazil + WHO) (& perhaps

China) considers liaising with AHWP • AHWP members considering options

• AHWP much more drive to build on GHTF model • IMDRF coming back to stakeholder involvement

IMDRF – starting projects

• NCAR system/PMS report improvement EU – Isabelle Demade

• Roadmap for implementation of the UDI EU – Laurent Selles

• Simple audit program – MD accreditation system USA – Kim Trautman

• Harmonized standards EU – Matthias Neumann

• Regulated product submission Canada – Mike Ward

ASEAN – following EU

• 601 M inhabitants • ASEAN Economic Community in 2020 • ASEAN Free Trade Association in 2015 • First integration 11 fields =>healthcare • Medical device legislation harmonised in 2014

• In place: CSDT, ISO 13485, ASEAN PMS, ASEAN alert • Target: ASEAN joint alert system in 2012 • Target: ASEAN MDD = AMDD:2014

Growing involvement WHO

• WHO member of IMDRF • WHO partner of AHWP • WHO issued report series ‘priority medical devices’ • WHO organised debate on cross-learning pharma

and devices

• Main driver: emerging economies depend heavily on import and should strive to reach high standards

MDACS HKCAB current issues 2012

Hong Kong

8 Pre-requisites of listing

• Approval will only be granted after the existing regulation is being complied

• CAB is recommended to have general understanding to the related HK ordinance Radiation Ordinance (Cap. 303) Pharmacy and Poisons Ordinance (Cap. 138) Antibiotics Ordinance (Cap. 137) Dangerous Drugs Ordinance (Cap. 134)

9 Timeline and potential change

• MDACS still voluntary at the moment Target to Formal Legislation: Mid-Late 2013

• LRP require to adopt QMS ISO 9001, ISO 13485 or GDP

• Frequency and Methodology of Conformity

Assessment MDCO suggesting CAB should not be an one-off

assessment Suggestion: One Surveillance per 2 years

Malaysia

Malaysia

• Legislative Bill in place • Implementing legislation being written • Third party audit and dossier reviews • Sign off local, work done by global resources • Time for CAB application ≈ Q2 2012

• Part of ASEAN, so 2014 might see AMDD

• Paul S. and Gert involved

Korea

ROC - Taiwan

Outline of Regulation

• Technical Cooperation Programme with Taiwan’s Department of Health Designated Auditing Organisations (DAO’s)

• QMS audit report recognition instead of MRA • Replaces the requirement to submit QMS

documentation for product registration in Taiwan • Issue letter from BSI + qualified auditor to cover

details on devices marketed in Taiwan • Additional product file to DOH

14

Scope of TCP

• All medical devices from EU manufacturers (AIMDD, MDD, IVDD), except animal tissue and combination products

• Based on ISO 13485 from NoBo • No time restraints • Alternatively, on top of design dossier submission,

Market Authorisation Holder may select off-site review of its QMS by Taiwanese officials

15

Chinese Taipei

• Exchange of letter US EU Swiss Liechtenstein • Future: PMS, STED, new ISO 13485 • TCP end June 2012 • To be replaced by TCP II • Most BSI concerns addressed • Recognising Taiwan audit report as NB ISO 13485

certificate • John, Vicky, Robin, Chris W. and Gert involved

The Kingdom of Saudi Arabia - KSA

Kingdom of Saudi Arabia

• The Country Climate, Culture Estimated population 27M, anticipated 30M by 2016

• 21M – Nationals, 6M ex-pats The SFDA are based in Riyadh Capital city is Riyadh, approx 3000 miles from London Country covers est. 800,000 square miles Currently 350 Hospitals/Healthcare Institutions, beds up to 70K

from 51K with the plan to build another 130 Hospitals/Healthcare Institutions

Medical Device market un-regulated Government Allocated 64,712.5M US$ up 82% for healthcare

infrastructure (episcom feb 2011)

Saudi FDA- Objectives

• The Medical Devices Sector is working toward becoming the leading regulatory authority in GCC (Gulf Cooperation Council) through achieving short and long term objectives. Among which are:

• Setting up Medical Devices & IVD Regulatory Law • Implementing Rules & Standards (SASO) • Implementing Regulatory System • Surveillance & Monitoring of the Market • Licensing procedures for MD manufacturers & suppliers • Cooperation with other Regulatory Agencies

SASO – Saudi Arabia Standards Organisation.

SFDA

• Move to a Regulated market Significant move to enforce from an unregulated market Improve patient safety Adverse events, currently little/no data available

• Patient death, serious injury, post market etc Restricted number of importation locations

• 9 to cover land, sea and air • Advance shipment notification

Cheap imports, local manufacturers Poor quality imports from other parts of the world “me to copies” of legitimate products/counterfeits Growth in population, slowly ageing society

Medical Devices Interim Regulations

• Structured around 11 - Chapters comprising 45 Articles, 8 - Implementing Rules (IR’s) 5 - Guidance Documents Additional information contained in “Periodic

Announcements”, eg 12/10/AN 001 to 006 incl dated 29th December.

The CAB’s provide the “Business/Technical Competence” to the SFDA, however all communication with the Companies is direct with the SFDA, CAB’s are very much backroom.

Basis for Market Authorisation

• Product has been placed on the market in any one of the 5 founding GHTF member jurisdictions Australia – Therapeutic Goods Regulations Canada – Health Canada EU – MDD’s Japan - JPAL US – FDA

• Additional requirements as specified in the MDIR Power supply Home use, Arabic language Storage, transportation,

Key Dates From 1st September 2010, 14th February 2011 medical devices having obtained an SFDA marketing authorisation may be placed on the Saudi market. Medical devices which are presently allowed on the KSA market may continue to be placed on the market, however, after 28th February 2011, now 14th August 2011 only medical devices that having obtained an SFDA marketing authorization may be placed on the market. After 30th June 2011, now 31st December 2011 only SFDA authorised medical devices may be put into service within the KSA, while devices in use at that date may continue to be utilised. Although the dates have passed, the SFDA has indicated that if Companies are engaged in the MDMA process some tolerance will be exhibited, and devices will not be impounded or scrapped at import.

Note: extract from SFDA Explanatory Memorandum – B The Interim Regulatory Scheme.

Current situation – Mar 2012

• Authorised Representatives – approx 150 -200 • Total number of applications to SFDA – in excess of 1200 • Total number of applications passed to CAB’s, difficult to

get an accurate figure, BSI have received approx 125, other CAB’s significantly less.

• By the end of Feb all five CAB’s will have staff on site: SGS, COSMOS, BSI, TUV SUD & Rheinland

• Quality of Applications, very mixed, with 1st time passes , others more than once, issues include not answering the question, providing the wrong information etc

• Volume is beginning to increase

USA

ISO 13485 Voluntary Audit Report Submission Pilot Program Guidance

• Manufacturers, in good compliance with QMS / QSR requirements

• Voluntarily submission ISO 13485 reports and certifications to FDA

• FDA to remove the manufacturer from the FDA Inspection schedule for 12 months

• ISO 13485 audit reports in the GD211 format specified by FDA

• BSI reports recognised by FDA

European Union

EU Regulatory changes - timelines

• Regulatory changes Review Directives - finalise draft in next months, then

approval and debates till 2013, applicable 2014-2016 E-labeling - applicable Q1 2013 IVD – vCJD - applicable mid 2012 – extension to scope Animal tissue - revised to include AIMD Eudamed - slow progress

• Code of Conduct Implementation review in Notified Bodies ongoing Next step is to propose supervisory structure: BSI and TUV Sud

EU regulatory update / 7+2 docs 1. MEDDEV Vigilance system (2.12-1 rev.7 ) Manufacturers Incident Report Form FSCA Manufacturers Trend reporting form Manufacturers Periodic Summary Reporting form

2. MEDDEV PMCF (2.12-2 rev.2) Aligned to GHTF guidance ISO 14155:2011 as basis for clinical studies details on the evaluation of PMCF

3. MEDDEV Authorised Representatives (2.5/10)

EU regulatory update / 7+2 docs 4. MEDDEV IVF ART (2.2/4) media, substances or mixture of substances used

during IVF and ART procedures basis for hazard and risk assessment toxic and carcinogenic additives, drug and human

derivatives added, clinical studies, Notified Body essentials, sterilisation and the appropriate use of clean rooms during production. Other sections detail classifications, traceability and vigilance reporting challenges.

5. MEDDEV IVD Borderline (2.14/1 rev.2)

EU regulatory update / 7+2 docs 6. MEDDEV stand-alone software (tbc) classification of software as therapeutic medical device software for diagnosis or therapy software in conjunction with IVDS

7. Meddev IVD-vCJD (tbc) I. Commission Directive 2011/100/EU of 22 December 2011

amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices

II. Commission Decision 2011/869 of 22 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices.

Both changes become effective on July 1 2012.

EU lecture at AHWP

• EU policy lines 2020 forward looking: Innovation drives public health Competitiveness crucial for sustainability Looking for solutions MD/drug 70+ Notified Bodies are too much; designation to core

competence Increased market surveillance, transparency etc. UDI preferred GS1 model, coexistence with HBIC NB role changing from compliance conformance and CE to

include monitoring throughout lifecycle, involvement in PMS

What will be in the MD and IVD Regulations? 34

Key Elements to the Framework

• Market Surveillance • Vigilance

• Notified Bodies • Clinical Evaluation • Transparency

=> All need improvement based on over a decade of experience

Member States

Notified Bodies

Industry

Before we forget, the current framework ....

• provided high degree of patient protection • is used as reference point in GHTF and in

developing legislation • is cost efficient and time effective • is externally reviewed as being equally safe as e.g.

US system, yet more innovation friendly • can be improved from within on certain points

36

What the PIP…….

• PIP is a case of well designed FRAUD • Public image of sector is challenged • European Parliament critical questions • Commission Dali held speech and wrote to MoHs Short term changes demanded Report to Parliament before summer break

• Legislative changes delayed with months or more • Reflections on system, not on product type

EU: current issues – TEAM-NB view

• Oversight: pool of auditors at EU level • Improvements from PIP-case Safety officer / qualified person Access to PMS data fro NBs Clarify TechFile content in Regulations Audit instructions on sampling design & manufacturing Hotline (whistle blowing) Unannounced visits

• Review high risk devices –prevent delays

ISO 13485 – 3rd edition

40 ISO 13485 3rd Revision Status

• ISOTC 210 – WG1 & GHTF SG3, met twice in 2011 April 2011, Justification Study & New Work Item Proposal

(NWIP) Oct 2011, review results of NWIP, areas for consideration

include: • Publication of 2007/47/EC

Clinical Data Post Market Surveillance Software as a Medical Device, including requirements

for validation • Swedish Competent Authority formal objection to ISO 13485

ISP 13485 contd.

• Areas for consideration contd. • EU Commission objections to several EN Standards

and harmonisation status etc including content and format of Annex Z’s

• Potential impact of any revision to ISO 9001, and the effect of the High Level Management System Standards proposal by ISO TMB

• Scope revision, reinforce focus on QMS not product, product life cycle, organisation to include manufacturer, re-processor, distributor etc

• Expand Risk Management requirements and provide greater clarity

41

ISO 13485 contd

• Areas for consideration contd • Emerging markets • Other regulatory regimes, geographic areas requirements • Management responsibility, personnel competence etc • In all 24 different topics/subject areas have been highlighted

• Next steps • WG1 & SG3 meet at Chiswick, 27th – 29th March 2012 • Review the work assignments given to the Task Groups in

October • Target Date of publication for 3rd Edition is 2014

42

Meanwhile: EN ISO 13485:2012

• To overcome formal objection Sweden • Adding details to Annex ZA, ZB, ZC • Focus on presumption of conformity from MDD,

IVD and AIMD • Normative text not changed • EN ISO 13485:2012 will be the harmonized version • ISO 13485 covers circa 50% of QMS requirements

EU legislation

The END ….

Future of BSI - Healthcare in Asia

Watch this space …….

Any further questions: Name: Gert Bos

Title: Head of Regulatory and Clinical Affairs

Address: BSI Kitemark Court, Davy Avenue Milton Keynes, UK

Mobile: +44 (0)7785 744960

Email: Gert.Bos@bsigroup.com Links: www.bsigroup.com/healthcare

www.linkedin.com/in/gertbos @bsihc @gertwbos

46

Or contact: - Dmitri Nikolaev - Ibim Tariah - Paul Sim - Tony Yip

47