17 th asean consultative committee on standards & quality - medical device product working group...

17th ASEAN Consultative Committee on Standards & Quality- Medical Device Product Working Group (ACCSQ-MDPWG)

UPDATES from MLIG-SMFMay Ng

Organised by: Supported by:

Awareness Seminar for Medical Device III (15 May 2013)

Copyright 2013, by May Ng

CONTENT

Background of ASEAN & ACCSQ-MDPWG

17th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF)- Medical Device Industry seminar (Malaysia)- Country updates in Public-Private Forum- 10th ACCSQ-MDPWG Technical Committee Meeting Report- 17th ACCSQ-MDPWG Meeting Report


10 countries

(Singapore, Malaysia,

Thailand, Brunei, Indonesia,

Philippines,

Cambodia, Laos, Myanmar,

Vietnam)

ASEAN Land Area: 4,464,322

sq km

ASEAN Population:

564,986,000

ASSOCIATION OF SOUTHEAST ASIAN NATIONS


5

ASEAN Economic Ministers Meeting (AEM)

ASEAN Senior Economic Officials Meeting (SEOM)

ASEAN Consultative Committee on Standards and Quality (ACCSQ) since 1992

ASEAN Summit Dec 97 ASEAN Vision 2020Oct 03 AEC 2020Jan 07 AEC 2015

(a) Single Market & Production Base eg Free flow(b) Competitive Economic Region eg IP (c) Equitable Economic Development eg IAI(d) Integration into the Global Economy eg IBP

Healthcare & e-ASEAN sectors Wood-based product & Automotives Rubber-based products & Textiles &

apparels Agro-based products & Fisheries Electronics Air Travel & Tourism Logistics

ASEAN Economic Community (AEC) & ACCSQ-MDPWG

ASEAN Economic Community (AEC) & ACCSQ-MDPWG

• Medical Device Product Working Group (MDPWG) since 3 - 4 Aug 2004

• Pharmaceutical Product Working Group (PPWG)

• Traditional Medicines and Health Supplements Product Working Group (PPWG)

• ASEAN Cosmetics Committee (ACC) Copyright 2013, by May Ng

6

ASEAN Medical Device DirectiveASEAN Medical Device Directive

ACCSQ-MDPWG Aim:

• To standardize the regulatory framework for regulating medical device among member states, with a set of principles in the AMDD.

• AMDD will help improve patient safety standards across the region and ensuring citizens of each of the ASEAN Member States have timely access to safe and effective medical devices, as well as providing a more straightforward path to market in the region for manufacturers of medical devices.

• AMDD targeted for implementation by Dec 2014.

Philosophies tools from the Global Harmonization Task Force


7

ASEAN Medical Device DirectiveASEAN Medical Device Directive

Article 1 General provisionsArticle 2 Definition and scope of medical deviceArticle 3 Essential principles of safety and performance of medical deviceArticle 4 Classification of medical devicesArticle 5 Conformity assessmentArticle 6 Registration and placement on the marketArticle 7 Registration of persons responsible for placing medical devices on the markets of member states Article 8 Technical documents for medical devicesArticle 9 Reference to standards and relevant documentsArticle 10 LabellingArticle 11 Product claimsArticle 12 Post-marketing alert systemArticle 13 Clinical investigationArticle 14 Institutional arrangementsArticle 15 Safe guard clausesArticle 16 ConfidentialityArticle 17 Special casesArticle 18 ImplementationArticle 19 Dispute SettlementArticle 20 Final provisions

Annex 1 Essential Principles of Safety and Performance of Medical DevicesAnnex 2 Risk Classification Rules for Medical Devices other than in-vitro diagnostic productsAnnex 3 Risk Classification Rules for In-Vitro Diagnostic ProductsAnnex 4 ASEAN Common Submission Dossier Template (CSDT)Annex 5 Post Marketing Alerts System (PMAS) Requirements Annex 6 Harmonized set of elements for a Product Owner’s or Physical Manufacturer’s Declaration of Conformity (DoC)Annex 7 Component Elements of a “Dear Healthcare Professional” Letter Annex 8 Sample Template of Letter of Authorisation Annex 9 Labelling RequirementsAnnex 10 Clinical Investigation – Pre-market Clinical Investigation to Support Marketing Authorisation Application

AMDD Version 11, Draft for National consultation, 8 May 12.


8

CONTENT


17th ACCSQ-MDPWG Meeting

- Pre-meeting training (for regulators by US-TATF)

- Medical Device Industry seminar (Malaysia)

- Country updates in Public-Private Forum

- 10th ACCSQ-MDPWG Technical Committee Meeting Report

- 17th ACCSQ-MDPWG Meeting Report


S/N AGENDA ITEMS DISCUSSED ITEMS1 ADOPTION OF AGENDA • Annex 1 List of delegates

• Annex 2 Provisional annotated agenda

2 BUSINESS ARRANGEMENT ~3 UPDATES ON THE RECENT

DEVELOPMENTS IN ASEAN ECONOMIC INTEGRATION INITIATIVES

• ASEAN harmonization is on technical requirements in ASEAN countries. It is not a single approval for ASEAN market.

• SEOM, AEC Deliverables for 2015 (ie 2013)• AEM, AMDD 2015 implementation roadmap• AEM, Non-Tariff measures in ASEAN Trade in Goods Agmt (ATIGA), AMS feedback if impacted AMDD. • Annex 3 AEC deliverables for 2015• Annex 4 AEC deliverables for 2013

4 MATTERS ARISING FROM THE 16th MDPWG MEETING

• Annex 5 MDPWG 16th Meeting on follow-up actions taken


S/N AGENDA ITEMS DISCUSSED ITEMS

5 DEVELOPMENT OF THE ASEAN MEDICAL DEVICE DIRECTIVE

5.1 AMDD Finalization

AMDD legal scrub by AMS 31 May 13AMDD legal scrub by Alegal 1 Jun 13AMDD endorse by ACCSQ 4-5 Jul 13AMDD endorse by SEOM 16 Sep 13AMDD endorse in ASEAN Summit 24th

•AMDD legal scrubbing & endorsement (see table)• AMDD public consultation - categorised as recommendations (excl. LOA, Dear HCP letter) clarifications, general or personal and typos. • IMDRF changes will be revised to AMDD if impacted patient safety • Annex 6 AMDD• Annex 7 AMDD public consultation presentation• Annex 8 Country updates to AMDD and timeline• Annex 9 AMDD roadmap's priority activities • CLMV under Initiative for ASEAN Integration (IAI) • AFMDI, entity associated with ASEAN ie ID, MY, PH, SG, TH & soon VN

5.2 Risk Classification of MD Guidelines • Annex 10 Risk classification, feedback by 30 Jun 13

5.3 Agreement on a Framework for Disseminating and Sharing of Information Relating to Adverse Events Associated with Medical Devices among ASEAN Member States

• Annex 11 Agreement, AMS to comment after AMDD legal scrubbed.


S/N AGENDA ITEMS DISCUSSED ITEMS6 8th MEDICAL DEVICE

TECHNICAL COMMITTEE REPORT

• ACSDT implementation in AMS (see table)• Standards, final feedback from TH & VN by 3 May 2013• Post market activitiesAnnex 12 AE formAnnex 13 FSCA formAnnex 14 8th MD Technical Committee reportACSDTSingapore Since 2010 Indonesia Since 2010 (partial English & local language)Thailand Since 2012 (partial English & local language)Cambodia Targeted 2013Malaysia Targeted Jul 2013Philippines Targeted end 2013Brunei Not yetLaos Not yet

7 NEW AREAS7.1 Refurbished Medical Devices • Malaysia's GRPMD based on COCIR, JIRA and MITA sharing

• PH guide in progress SG allowed and ID not regulated.

7.2 In-vitro Diagnostic Medical Devices (IVDs)

• ACSDT IVD differ from MD on the pre-clinical testing, feedback by 30 June 2013

8 NOMENCLATURE OF MEDICAL DEVICES

• Annex 17 Nomenclatures by MIMOS. Noted GMDN, UMDNS, SNOMED, ICD-10, LOINC correlated. Continue to shareeg ID using HS code in INSW, TH not yet


S/N AGENDA ITEMS DISCUSSED ITEMS9 COOPERATION WITH INTERNATIONAL AND REGIONAL ORGANISATIONS 9.1 Cooperation with the IMDRF • Annex 18 IMDRF 3rd meeting (5 GHTF, Brazil, Canada, AHWP

affiliated organization, Russia and Mexico observer) - NCAR, UDI, SAP, Std, Pdt Submission. IMDRF 12-14 Nov 13 Brussels.

9.2 Cooperation with WHO • Continue follow-up regional office of WHO SEARO-WPR, WHO-US

10 Technical assistance and cooperation with dialogue partners

• Annex 19 Concept note on US-funded training prioritized based on AMDD roadmap

- Indonesia (26-27 Aug regulators & 28-29 Industry)- Thailand (21-23 Aug regulators & industry, ie CLM)-Vietnam (late Jul regulators & industry)

11 OTHER MATTERS • MDPWG Trust Fund closure, after funded Myanmar delegates to 16th meeting.

12 WORK PROGRAMME Annex 20 MDPWG Work programme

13 NEXT MEETING Annex 21 MDPWG List of Meetings

14 ADOPTION OF REPORT Adopted for next meeting in October, Brunei.


CONTENT


17th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF)- Medical Device Industry seminar (Malaysia)- Country updates in Public-Private Forum- 10th ACCSQ-MDPWG Technical Committee Meeting Report- 17th ACCSQ-MDPWG Meeting Report Excl.


Regulatory Authority

Center for Device Regulation, Radiation Health, and Research (CDRRHR) Food and Drug Administration, Department of Health

MD regulation

• Republik Act 3720 in June 1963, 'Food, Drug and Cosmetic Act' - regulated manufacture and distribution of food, drugs and cosmetics

• Executive Order No. 175 amended RA3720, add regulation of MD to BFAD• Executive Order No. 102, created BHDT but not enacted to regulated MD• Republic Act No. 9711 in Aug 2009 created FDA, DOH strengthen

regulatory in food, drug, cosmetics, MD and other health devices (BFAD & BHDT in FDA)

Philippines


Regulatory control

1) Establishment License• Manufacturer, Distributor/importer, Distributor/wholesaler, Retailer• Leadtime : 90 days ie inspection

2) Product registration• Class 1, 2, 3,4; per product/brand/model excl. size and shape• Leadtime: 180 days • e-copy dossier and hardcopy returning for co. record since 2011

3) AE & Recall reporting

4) PMS

Philippines


Class 1 Class 2 Class 3 Class 4Legal requirements• Application form, notarized• Medical device establishment license issued by the CDRRHR• Agreement with licensed local manufacturer and distributor, notarized• Registration of product issued by the health authority from the country of origin and foreign agency agreement, both notarized and duly authenticated by the Philippine Consulate (for imported product)

Technical Requirements, based on the ACSDT•Device description•Description of the sterilization method and the packaging used, the sterility level and the validation of the sterilization process (if applicable)•Certificate of Conformity to the aspect of manufacture relating to metrology for devices with measuring functions•Declaration of Conformity with product standards (if applicable)•Sample of labels on the device and its packaging and other labeling materials to be used for the device that includes user’s or instruction manuals•Government certificate attesting to the status of the Manufacturer ‘s competency and reliability of the personnel and facilities or QS Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485. (for imported product, Certificate to be duly authenticated by the territorial Philippine Consulate)•Stability studies (if applicable)•Picture of the product and representative sample or commercial presentation of the product (when needed)

•Executive Summary•Relevant essential principles and method/s used to demonstrate conformity (if applicable•Device description*•Design Verification and Validation Documents*•Risk assessment consisting of risk analysis, evaluation and reduction measures, (if applicable)*•Manufacturer information including the process, quality assurance*•Clinical evidence (if applicable)*

•Software validation studies (if applicable)•Biological evaluation (if applicable)*

•List of countries where the device has been sold

Philippines

* varies depend on device class Copyright 2013, by May Ng


Medical Devices Control Division, Food and Drug Administration

MD regulation

• Drug Act, bfr 1988• Medical Device Act 1988 & MDCD, FDA since June 1990• Ministerial Notification: Requiements on recording & reporting of

manufacturing/importing/selling of MD, 7 June 2011• Ministerial Regulations & FDA notifications: Application & Issuing of

Manufacturing/Importing MD Licenses & Notifications (CSDT), 28 May 2012

Thailand


Regulatory control

1) Establishment License• Manufacturing, Importing• Leadtime : 90 days ie inspection

2) Selling Licence (some device)• Licensed (condoms, surgical gloves, HIV IVD, contact lens ie cosmetic use, blood

bag ie with anti-coagulant); Notified (physical therapy, alcohol detector, breast implants, breast enhancer external use, etc); General

• Class 1, 2, 3,4Leadtime: 180 days, per product/brand/model excl. size and shape

3) Post-Marketing - check premises, sampling, vigilance, AE, One Stop Service Center – Pre-market, pre-advertisement, cert issuance; One Stop Complaint Center – Post- market, post-advertisement, enforcementNetwork of control - provincial, port, police, lab/standard, healthcare professional/expertise

Thailand


Regulatory control - updates

• MD definition ie animal use, IVD, software, accessories, components or parts, any announced by minister

• MD reclassification

•National single window/licence per invoice (targeted Sep/Dec 2013)

•Database: Importer Co. Reg. No. ID code, Product License/Notification/Import permit letter No., HS code, Product code, City & Country of Origin

• Outsource program

• AMDD & AEC 2015

Thailand



Medical Device Production and Distribution Service, Pharmaceutical & Medical Device Service, MOH

MD regulation and policy

• Act on health• Gov regulation• Production, Distribution, registration of medical devices & household• National Medical Device Policy• Product under regulation - Premarket control & Postmarket control• Use under Health Technology Management - Assessment, Procurement,

User, Maintenance • Risk based, ASEAN harmonization, International std, transparency &

excellent service reformation

Indonesia


Regulatory control

Pre-market control•CSDT, QMS ISO 13485 , National & International Std•Registration no., product name, product generic name, type/size (all accessories in attached licence), Manufacturer name & Address, Distributor name & address, HS code, release date, expired date, country of origin, •Validity 5 years

Post-market control •Sampling, monitoring production and distribution facilities to QS standard, vigilance eg AE report, PMS (MOH with civil police investigator working with healthcare facilities, police, customs, health province officer

Indonesia


Indonesia National Single Window(http://eservice.insw.go.id)National system that integrates all entities which related to customs clearance to accelerate the process of import-export services and traffic.- National Trade Repository- Single sign on

e-Registration (http://regalkes.depkes.go.id)- Registration no.- Production License- Distributor License (GDP)

e-Catalogue(http://inaproc.lkpp.go.id/v3/public/ekatalog/ekatalog.htm)- Government procurement for goods and

services, President decree No. 70/2012- transparent, accountable, effective, efficient,

decrease MD less 40%, decrease healthcare expenditure f0or Social Security program & MDGs

- Name, type, specification, price , service guaranteee-Planning

e-Monitoring

Indonesia


http://eservice.insw.go.id/



http://inaproc.lkpp.go.id/v3/public/ekatalog/ekatalog.htm

http://inaproc.lkpp.go.id/v3/public/ekatalog/ekatalog.htm


Drug Control Division, Food and Drug Department, MOH


• The National Drug Policy was endorsed in 1993, and revised in 2003• Drug and Medical Product Law enacted since April 2000, 2nd and ie risk

class A,B,C,D, endorsed by National Assembly last year (2012)• Regulation regarding drug and medical product company• establishment No. 1442 dated 13 August 2003 (Importer or• Distributor authorization)• Supervision and monitoring tools based on the Good Wholesaling Practice

(GWP)

Regulatory control

• MD control committee, AMDD, guideline in progress, MD list and it use in health care facility has been established by Medical Product Supply Centre with FDD; Medical equipments in central and provincial hospitals in ID system

Lao PDR



Medical Device Section, Registration Bureau, Department of Drugs, Food, Cosmetics and Medical Devices, MOH


• Constitution of the Kingdom of Cambodia• Reach Kret No ns/rkt 0908/1055 dated 25 September 2008 establishing the Royal

Government of Cambodia.• Reach Kram No ns/rkm/ 0196/06 dated 24 January 1996 establishing the MOH• Reach Kram No Cs/rkm/ 0696/02 approval of the Drug law dated 17 June 1996• Sub Decree No 67 GnRk/kt dated 22 October 1997 empowering the Ministry of ‐

Health to undertake activities related to Health Service.• Sub Decree No 44 GnRk/kt dated 10 August 1994 Pharmaceutical Registration‐• Prakas No 145 Gbs dated 14 / 03 / 2001 consumable device registration• Prakas No Gbs dated 2000 reagent registration

Cambodia


Regulatory control

• Flow: Licensing of Manufacturer, importer; Product registration no.; Imported license of registered products

• Process: submit dossier, evaluation and computerised system, complete document, payment, passed committe meeting, licensing.

• new regulation Nov 2012: definition, 4 classes, CSDT (excl. Class A)

Class A ‐ Application form ‐ GMP or ISO Certificate (ISO 13485) ‐ FSC issued by Health Authority ‐ Letter of Authorization

Class B, C and D ‐ Application form ‐ GMP or ISO Certificate (ISO 13485) ‐ FSC issued by Health Authority ‐ Letter of Authorization

- Registration Certificates in other countries (if available) ‐ Testing Report ‐ Technical documents: CSDT (requirement increase with risk)

Leadtime: 90 days,Validity: 3 yearsrenewal 6mths bfr expired.

Cambodia



Healthcare Technology Department , MOH

MD regulation and legal framework

• Drafting MD regulations & policies• Voluntary implementation to be carry out• No mandatory control

Regulatory control – Premarket & Postmarket

Pre-market control• Business Establishment Licensing• Development of QMS certification procedures, specifications and guidance• Product registration• AMDD technical requirements, ACSDTPost-market control• MDPWG forms and develop procedures and forms, strengthen surveillance

Brunei

Medical device

Regulation

Legal Framewor

k

Pre-market control

Post-market control

Technical capacity Building



Medical Device Authority, MOH


• Medical device regulatory program proposal approval by Cabinet, 16 Feb 2005• Medical Devices Control Division established in Aug 2005, for MD bill and legislation,

program, registration & surveillance/vigilance system • MEDICAL DEVICE AUTHORITY ACT 2012 (ACT 738), Gazetted 9 Feb 2012 & Effective 15

Mar 2012• MEDICAL DEVICE ACT 2012 (ACT 737), Gazetted 9 Feb 2012 & Effective 30 Jun 2013• MEDICAL DEVICE REGULATIONS 2012, Gazetted Dec 2012 & Effective 1 Jul 2013• Orders, other legislative tool

- Permit for designated medical device- Others to be determined, post market requirements, advertising and usage (ie maintenance, installation, T&C and disposal)

• Guidance Documents, Standards

Device definition..i(b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a MEDICAL DEVICE by order published in the Gazette.

Malaysia


(ACT 737 - 6 Parts, 80 Sections)

Part I : Preliminary Part II: Registration of Medical Device and Conformity Assessment Body Chapter 1: Registration of medical device Chapter 2: Registration of conformity assessment body Part III: Licence and Permit Chapter 1: Establishment licence Chapter 2: Designated medical device permit Chapter 3: Duties and obligations of licensees or permit holders Chapter 4: General duty Chapter 5: Export permit Part IV: Appeal Part V: Enforcement

(MDR 2012 - 14 Parts, 61 Sections)

Part I : Preliminary Part II: Conformity Assessment Procedures Part III: Registration of Medical Device Part IV: Registration of Conformity Assessment Body Part V: Establishment Licence Part VI: Export Permit Part VII: Labelling Requirements Part VII: Duties and Obligation of Licensees Part IX: Exemption of any person or medical device from any provision of this Act Part X: Usage, Operation, Maintenance Part XI: Requirements for provision of auditing, consulting or Training related to medical device regulatory matters Part XII: Appeal Part XIII: Register Part XIV: Prescribed fees


Act & Regulations Malaysia


16 Feb05

09 Feb12

09 Feb12

15 Mar12

14 Jun12

31 Dec12

30 Jun13

01 Jul13

30 Jun14

30 Jun15

Act 737 Part VI: General, Section 80: Savings and transitional– 80(1): A person who has imported, exported or place in the market any medical device prior to appointed date of the Act shall apply for registration of medical device within 24 months from the appointed date– 80(2): A person who has imported, exported or place in the market any medical device and intend to continue shall apply for establishment licence within 12 months from the appointed date– 80(3): A person in 80(1) or 80(2) may continue to import, export or place in the market the medical device pending determination of application


MalaysiaAct & Regulations timeline

Cabinet approved proposal to develop MD regulatory system

Medical Device Control Division established

Act 737. Act 738 gazetted

Act 738 comes into operation

Medical Device Authority (MDA) established

Medical Device Regulations (MDR) 2012 gazetted

Act 737 comes into operation

Effective date of MDR 2012

Enforcement of establishment license

Enforcement of medical device registration

Medical Device Control Division (MDCD)

Medical Device Authority (MDA)

Transition – establishment license

Transition – MD registration

Appointment of members of the Authority

Cessation of MDCD

PRE-MARKET ASSESSMENTManufacturers of medical devices shall -• ensure their products conform to Essential Principles for Safety

& Performance (EPSP) of Medical Device• establish appropriate quality system for manufacturing • collect evidence of conformity

MDA issues licenses, registers medical devices and monitors compliance to requirements & takes appropriate actions in accordance with the law

MEDICAL DEVICE REGISTRATION• Manufacturer (or authorized

representative) apply to register medical devices & establishment license

ESTABLISHMENT LICENSING• Importers/distributors shall

ensure compliance to GDP & advertising requirements

• apply for establishment license to import/distribute medical devices

SURVEILLANCE & VIGILANCE• Establishments

shall monitor safety & performance of products

• carry out post-market obligations, eg complaint handling, FSCA, recall

USAGE & MAINTENANCE

• Users shall use, maintain & dispose off medical devices appropriately

• Users shall apply for permit to use/operate designated medical devices

CAB verifies evidence of conformity


THANK YOU

Acknowledgement to: BIOSENSORS INTERNATIONAL GROUP SINGAPORE HQ

• Health Products Act - www.agc.gov.sg

• Global Harmonization Task Force (GHTF) - www.ghtf.org

• Asian Harmonization Working Party (AHWP) - www.asiahwp.org

• ACCSQ Medical Device Product Working Group - www.accsq-mdpwg.org


17 th asean consultative committee on standards & quality - medical device product working group...

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