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17 th ASEAN Consultative Committee on Standards & Quality - Medical Device Product Working Group (ACCSQ-MDPWG) UPDATES from MLIG-SMF May Ng Organised by:

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Presentation on theme: "17 th ASEAN Consultative Committee on Standards & Quality - Medical Device Product Working Group (ACCSQ-MDPWG) UPDATES from MLIG-SMF May Ng Organised by:"— Presentation transcript:

1 17 th ASEAN Consultative Committee on Standards & Quality - Medical Device Product Working Group (ACCSQ-MDPWG) UPDATES from MLIG-SMF May Ng Organised by: Supported by: Awareness Seminar for Medical Device III (15 May 2013) Copyright 2013, by May Ng

2 CONTENT Background of ASEAN & ACCSQ-MDPWG 17 th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF) - Medical Device Industry seminar (Malaysia) - Country updates in Public-Private Forum - 10 th ACCSQ-MDPWG Technical Committee Meeting Report - 17 th ACCSQ-MDPWG Meeting Report Copyright 2013, by May Ng

3 CONTENT Background of ASEAN & ACCSQ-MDPWG 17 th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF) - Medical Device Industry seminar (Malaysia) - Country updates in Public-Private Forum - 10 th ACCSQ-MDPWG Technical Committee Meeting Report - 17 th ACCSQ-MDPWG Meeting Report Copyright 2013, by May Ng

4 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 Copyright 2013, by May Ng

5 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 2020 Oct 03 AEC 2020 Jan 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 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 6 ASEAN 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 Philosophies tools from the Global Harmonization Task Force Copyright 2013, by May Ng

7 7 ASEAN Medical Device Directive Article 1 General provisions Article 2 Definition and scope of medical device Article 3 Essential principles of safety and performance of medical device Article 4 Classification of medical devices Article 5 Conformity assessment Article 6 Registration and placement on the market Article 7 Registration of persons responsible for placing medical devices on the markets of member states Article 8 Technical documents for medical devices Article 9 Reference to standards and relevant documents Article 10 Labelling Article 11 Product claims Article 12 Post-marketing alert system Article 13 Clinical investigation Article 14 Institutional arrangements Article 15 Safe guard clauses Article 16 Confidentiality Article 17 Special cases Article 18 Implementation Article 19 Dispute Settlement Article 20 Final provisions Annex 1 Essential Principles of Safety and Performance of Medical Devices Annex 2 Risk Classification Rules for Medical Devices other than in-vitro diagnostic products Annex 3 Risk Classification Rules for In-Vitro Diagnostic Products Annex 4 ASEAN Common Submission Dossier Template (CSDT) Annex 5 Post Marketing Alerts System (PMAS) Requirements Annex 6 Harmonized set of elements for a Product Owners or Physical Manufacturers 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 Requirements Annex 10 Clinical Investigation – Pre-market Clinical Investigation to Support Marketing Authorisation Application AMDD Version 11, Draft for National consultation, 8 May 12. Copyright 2013, by May Ng

8 8 CONTENT Background of ASEAN & ACCSQ-MDPWG 17 th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF) - Medical Device Industry seminar (Malaysia) - Country updates in Public-Private Forum - 10 th ACCSQ-MDPWG Technical Committee Meeting Report - 17 th ACCSQ-MDPWG Meeting Report Copyright 2013, by May Ng

9 S/NAGENDA ITEMSDISCUSSED ITEMS 1ADOPTION OF AGENDA Annex 1 List of delegates Annex 2 Provisional annotated agenda 2BUSINESS ARRANGEMENT~ 3UPDATES 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 MATTERS ARISING FROM THE 16th MDPWG MEETING Annex 5 MDPWG 16th Meeting on follow-up actions taken Copyright 2013, by May Ng

10 S/NAGENDA ITEMSDISCUSSED ITEMS 5DEVELOPMENT OF THE ASEAN MEDICAL DEVICE DIRECTIVE 5.1AMDD Finalization AMDD legal scrub by AMS 31 May 13 AMDD legal scrub by Alegal 1 Jun 13 AMDD endorse by ACCSQ 4-5 Jul 13 AMDD endorse by SEOM 16 Sep 13 AMDD endorse in ASEAN Summit 24 th 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 5.2Risk Classification of MD Guidelines Annex 10 Risk classification, feedback by 30 Jun 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. Copyright 2013, by May Ng

11 S/NAGENDA ITEMSDISCUSSED ITEMS 68th MEDICAL DEVICE TECHNICAL COMMITTEE REPORT ACSDT implementation in AMS (see table) Standards, final feedback from TH & VN by 3 May 2013 Post market activities Annex 12 AE form Annex 13 FSCA form Annex 14 8th MD Technical Committee report ACSDT SingaporeSince 2010 IndonesiaSince 2010 (partial English & local language) ThailandSince 2012 (partial English & local language) CambodiaTargeted 2013 MalaysiaTargeted Jul 2013 PhilippinesTargeted end 2013 BruneiNot yet LaosNot yet 7NEW AREAS 7.1Refurbished Medical Devices Malaysia's GRPMD based on COCIR, JIRA and MITA sharing PH guide in progress SG allowed and ID not regulated. 7.2In-vitro Diagnostic Medical Devices (IVDs) ACSDT IVD differ from MD on the pre-clinical testing, feedback by 30 June NOMENCLATURE OF MEDICAL DEVICES Annex 17 Nomenclatures by MIMOS. Noted GMDN, UMDNS, SNOMED, ICD-10, LOINC correlated. Continue to share eg ID using HS code in INSW, TH not yet Copyright 2013, by May Ng

12 S/NAGENDA ITEMSDISCUSSED ITEMS 9COOPERATION WITH INTERNATIONAL AND REGIONAL ORGANISATIONS 9.1Cooperation 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 Nov 13 Brussels. 9.2Cooperation with WHO Continue follow-up regional office of WHO SEARO-WPR, WHO-US 10Technical assistance and cooperation with dialogue partners Annex 19 Concept note on US-funded training prioritized based on AMDD roadmap - Indonesia (26-27 Aug regulators & Industry) - Thailand (21-23 Aug regulators & industry, ie CLM) -Vietnam (late Jul regulators & industry) 11OTHER MATTERS MDPWG Trust Fund closure, after funded Myanmar delegates to 16th meeting. 12WORK PROGRAMMEAnnex 20 MDPWG Work programme 13NEXT MEETINGAnnex 21 MDPWG List of Meetings 14ADOPTION OF REPORTAdopted for next meeting in October, Brunei. Copyright 2013, by May Ng

13 CONTENT Background of ASEAN & ACCSQ-MDPWG 17 th ACCSQ-MDPWG Meeting - Pre-meeting training (for regulators by US-TATF) - Medical Device Industry seminar (Malaysia) - Country updates in Public-Private Forum - 10 th ACCSQ-MDPWG Technical Committee Meeting Report - 17 th ACCSQ-MDPWG Meeting Report Excl. Copyright 2013, by May Ng

14 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 in Aug 2009 created FDA, DOH strengthen regulatory in food, drug, cosmetics, MD and other health devices (BFAD & BHDT in FDA) Philippines Copyright 2013, by May Ng

15 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 ) AE & Recall reporting 4) PMS Philippines Copyright 2013, by May Ng

16 Class 1Class 2Class 3Class 4 Legal 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 users 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 (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

17 Regulatory Authority 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 Copyright 2013, by May Ng

18 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, 3,4 Leadtime: 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, enforcement Network of control - provincial, port, police, lab/standard, healthcare professional/expertise Thailand Copyright 2013, by May Ng

19 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 Copyright 2013, by May Ng

20 Regulatory Authority 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 Copyright 2013, by May Ng

21 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 Copyright 2013, by May Ng

22 Indonesia National Single Window (http://eservice.insw.go.id(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 ( -Registration no. -Production License -Distributor License (GDP) e-Catalogue (http://inaproc.lkpp.go.id/v3/public/ekatalog/ek atalog.htm(http://inaproc.lkpp.go.id/v3/public/ekatalog/ek atalog.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 guarantee e-Planning e-Monitoring Indonesia Copyright 2013, by May Ng

23 Regulatory Authority Drug Control Division, Food and Drug Department, MOH MD regulation and policy 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 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 Copyright 2013, by May Ng

24 Regulatory Authority Medical Device Section, Registration Bureau, Department of Drugs, Food, Cosmetics and Medical Devices, MOH MD regulation and policy 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 SubDecree No 67 GnRk/kt dated 22 October 1997 empowering the Ministry of Health to undertake activities related to Health Service. SubDecree 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 Copyright 2013, by May Ng

25 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 years renewal 6mths bfr expired. Cambodia Copyright 2013, by May Ng

26 Regulatory Authority 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, ACSDT Post-market control MDPWG forms and develop procedures and forms, strengthen surveillance Brunei Medical device Regulation Legal Framework Pre-market control Post-market control Technical capacity Building Copyright 2013, by May Ng

27 Regulatory Authority Medical Device Authority, MOH MD regulation and policy 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 Copyright 2013, by May Ng

28 (ACT 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 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 Copyright 2013, by May Ng Act & Regulations Malaysia

29 Copyright 2013, by May Ng 16 Feb0509 Feb12 15 Mar12 14 Jun1231 Dec1230 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 Copyright 2013, by May Ng Malaysia Act & Regulations timeline Cabinet approve d proposal to develop MD regulator y system Medical Device Control Division establishe d Act 737. Act 738 gazetted Act 738 comes into operation Medical Device Authority (MDA) establishe d Medical Device Regulations (MDR) 2012 gazetted Act 737 comes into operation Effective date of MDR 2012 Enforcem ent of establish ment license Enforce ment of medical device registrati on Medical Device Control Division (MDCD) Medical Device Authority (MDA) Transition – establishment license Transition – MD registration Appointment of members of the Authority Cessation of MDCD

30 PRE-MARKET ASSESSMENT Manufacturers 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 PRE-MARKET ASSESSMENT Manufacturers 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 MEDICAL DEVICE REGISTRATION Manufacturer (or authorized representative) apply to register medical devices & establishment license 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 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 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 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 Copyright 2013, by May Ng

31 THANK YOU Acknowledgement to: BIOSENSORS INTERNATIONAL GROUP SINGAPORE HQ Health Products Act - Global Harmonization Task Force (GHTF) - Asian Harmonization Working Party (AHWP) - ACCSQ Medical Device Product Working Group - Copyright 2013, by May Ng


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