SUMMARY REPORT OF THE 17 th ACCSQ MDPWG MEETING

Transcription

1 SUMMARY REPORT OF THE 17 th ACCSQ MDPWG MEETING INTRODUCTION 1) The 17 th Meeting of the Medical Device Product Working Group (MDPWG) was held on April 2013 in Petaling Jaya, Malaysia. The Meeting was preceded by the following meetings at the same venue: a) Working on Medical Device on April 2013; b) Medical Device Public Private Forum on 24 April 2013; c) 8 th Medical Device Technical committee (MDTC) on 24 April 2013; d) MDPWG Heads of Delegation (HoDs) Meeting on 24 April 2013; and e) 17 th MDPWG Meeting on April ) The Meeting was chaired by Mr. Zamane Abdul Rahman, Chief Executive Officer, Medical Device Authority, Ministry of Health, Malaysia and co-chaired by Mrs. Joanna Koh, Director Operations and Policy, Group Directors Office, Compliance Branch, VCE Division, Health Products Regulation Group, Health Sciences Authority, Singapore 3) The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Philippines, Singapore, Thailand, Vietnam and representatives from the ASEAN Secretariat. The representatives from ASEAN medical device industries were also in attendance as observers. AGENDA ITEM 1: ADOPTION OF AGENDA 4) The Meeting adopted the amended agenda. AGENDA ITEM 2: BUSINESS ARRANGEMENT 5) The meeting was held in plenary. AGENDA ITEM 3: UPDATES ON THE RECENT DEVELOPMENTS IN ASEAN ECONOMIC INTEGRATION INITIATIVES 6) The ASEAN Secretariat updated the Meeting on the outcome of the recent developments in the ASEAN economics integration efforts in particular the decisions made by the ASEAN Economic Ministers (AEM), Senior Economic Officials Meeting and the ASEAN consultative Committee for Standards and Quality. 7) The Meeting noted the dates of the AEM Meeting and SEOM as follows: a) AEM Meeting 10 th AEM Retreat March 2013 Vietnam 45 th AEM August 2013 Brunei Darussalam b) SEOM SEOM 1/ January 2013, Jerudong,Brunet Darussalam Prep-SEOM April 2013,Brunei Darussalam

2 SEOM 2/ May 2013,Brunei Darussalam SEOM 3/ July 2013 Brunei Darussalam Prep-SEOM August 2013,Brunei Darussalam 8) The meeting noted that the SEOM 1/44 endorsed the Report of the 39 th ACCSQ Meeting and the AEC Deliverables for The SEOM agreed to prioritize the SEOM list of deliverables by identifying one or two key deliverables for each sector that can be realistically achieved in 2013 and in this regard the SEOM requested the ASEAN Secretariat to follow-up with the Sectoral Bodies on the prioritization of deliverables under their purview. The AEC Deliverables for 2013 based on the work program of the WGsPWGs under the purview of ACCSQ. 9) The Meeting noted that the AEM noted the importance of rectify the current misperceptions in the business community that the AEC 2015 would function like the European Union Single Market. The AEM agreed to maintain consistency in the messages conveyed though national outreach programmes to clarity to the business community what constituted free flow of goods, services, investment, etc by In this regard, the AEM agreed that ASEAN should begin work on a post vision or work plan which will be presented to the ASEAN Leaders for the consideration and launching in The Meeting agreed to consider the possible development of a Roadmap for Implementation of the ASEAN Medical Device Directive (AMDD) 10) The Meeting also noted that the AEM has recognized the growing importance in addressing Non-Tariff Barriers as ASEAN works towards realizing achieving AEC by 2015 and urgent at ASEAN Member States to adhere to the obligations to notify all Non-Tariff Measures as mandated under Article 11 of the ASEAN Trade in Goods Agreement (ATIGA) in this regard. The Meeting noted that Member States may need to inform the MDPWG if there are any national regulations under consideration that may have an impact on the implementation of the AMDD AGENDA ITEM 4: MATTERS ARISING FROM THE 16 th MDPWG MEETING 11) The ASEAN Secretariat briefed the Meeting on the follow up actions taken on matters arising from the 16 th MDPWG Meeting which was held on October 2012 in Yogyakarta, Indonesia. 12) The Meeting noted the action taken on matters arising from the 16 th MDPWG Meeting and agreed to discuss the pending issues under the corresponding agenda of the meeting AGENDA ITEM 5 DEVELOPMENT OF THE ASEAN MEDICAL DEVICE DIRECTIVE 5.1 DISCUSSION ON THE FINALIZATION OF THE DRAFT ASEAN MEDICAL DEVICE DIRECTIVE (AMDD) 13) The Chair briefed the Meeting on the outcome of the Special MDPWG HoDs Meeting held on March 2013 in Singapore to finalize the AMDD for endorsement at the 17 th MDPWG Meeting. 14) Singapore briefed the Meeting on the revision of the draft AMDD based on the comments received from the stakeholder during the public consultation. 15) The Meeting noted that the comments received during the public consultation were categorized recommendations, clarifications, general or personal comments and typing errors. 16) The Meeting reviewed the proposed activities and timelines associated with the finalization and signing of the AMDD.

3 17) The Meeting was informed that the ACCSQ agreed to consider the endorsement of the final draft AMDD through e-communications in the event the final draft AMDD is not ready to be tabled at the ACCSQ leaders meeting which will be held on 4-5 July The Meeting also agreed that it may not be necessary to hold a MDPWG HoD Meeting if the comments received after the legal scrubbing is not technical or substantial in this regard. The Meeting agreed to organize a teleconference during the third week of June 2013 to discuss the outcome of the scrubbing Malaysia agreed to assist with organization of the teleconference. 18) The Meeting discussed the progress made by in the international Medical Device Regulators Forum (IMDRF) on the revisions to the classification of medical devices and other related changes. The Meeting agreed that the progress made in IMDRF with regards to regulatory requirements for medical devices will be regularly reviewed and changes to the AMDD will only be made of the revised regulatory requirements are a major change that will have an impact on patient safety. 19 The Meeting discussed the national efforts taken for the implementation of the AMDD and the associated timelines. The Meeting noted that the Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Philippines and Thailand presented the updates on the medical device regulatory requirements during the Medical Device Public- Private Forum which was held on 24 April 2013 in Petaling Jaya, Malaysia. 20) The Meeting discussed the Roadmap for implementation of the AMDD and agreed to identify the priority activities that need to be considered to support the smooth implementation of the AMDD. The identified priority activities for the Roadmap for the implementation of the AMDD appear as ANNEX 9. The Meeting requested the ASEAN Secretarial to assist with the development of the Roadmap for consideration by the Heads of Delegates. 21) The Meeting also noted the available support for CLMV under the Initiative for ASEAN Integration Work Plan 2 ( ) to narrow the development gap (NDG) in the standards and conformance area amongst others. In this regard, the Meeting agreed to consider support for the CLMV for the implementation of the AMDD through the IAI. 22) The Meeting also noted that the ASEAN Federation of the Medical Device Industry (AFMDI) has been established and its members comprise medical device industry associations from Indonesia, Malaysia, Philippines, Singapore and Thailand. The medical device industry association from Vietnam is expected to join the AFMDI. The AFMDI also informed the Meeting that efforts are being taken for the AFDMI to be an entity associated with ASEAN. 5.2 DISCUSSION ON THE GUIDELINES FOR CLASSIFICATION OF MEDICAL DEVICES 23) Singapore briefed the Meeting on the proposed Guidelines for Risk Classification of Medical Devices which was circulated to the Member States for comments at the 15tg MDPWG Meeting. 24) The Meeting noted that the guidelines aim to assist companies or persons who place medical devices on the markets of ASEAN Member States on the risk classification of general medical devices using the appropriate risk-based classification rules. The Meeting noted that the guidelines could be used to support the implementation of the AMDD On how to apply the risk classification of the medical devices. The meeting requested the Member States to review the proposed guidelines and provide their feedback to Singapore by 30 June DISCUSSION ON THE AGREEMENT ON FRAMEWORK FOR DISSEMINATING AND SHARING OF INFORMATION RELATING TO ADVERSE EVENTS ASSOCIATED WITH MEDICAL DEVICES AMONG ASEAN MEMBER STATES

4 25) The Meeting discussed the progress made with the finalization of the Agreement on a framework for Disseminating and Sharing of Information relating to Adverse is Associated with Medical Devices among ASEAN member States. 26) The Meeting recalled the decision made by the HoDs that the draft agreement be reviewed after the final draft AMDD has been legally scrubbed to ensure consistency. The Meeting noted that this agreement is aimed to provide the legal basis sharing confidentiality information in adverse event reporting. The Meeting requested the Member States to cut internal consultations on the protocol of each Member State. AGENDA ITEM 6: REPORT OF THE 8 th MEDICAL DEVICE TECHNICAL COMMITTEE 27) The Chair of the MDTC briefed the Meeting on the outcome of the 8 th MDTC Meeing held on 24April 2013 in Petaling Jaya, Malaysia. 28) The Meeting noted the following progress made a) Implementation of the ASEAN Common Submission Dossier Template Brunei Darussalam has not implement the ACSDT Cambodia has targeted for the implementation of the ACSDT in July 2013 Lao PDR has not implemented the ACSDT Indonesia has adopted and implemented the ACSDT since 2010 and it is required to submit the ACSDT partially in English and nation language Malaysia has adopted the ACSDT in the medical device regulation and the implementation of the ACSDT is targeted for July 2013 Philippines has targeted for the implementation of the ACSDT by end of 2013 Singapore has implemented the ACSDT since 2010 in the English language and Thailand has implement the ACSDT since 2012 partially in English and national language. Training are carried out for the industry Vietnam has implemented the ACSDT since 2011 b) Harmonization of standards Thailand and Vietnam have been requested to provide the feedback of status of adoption of the list of Standard identified or harmonization to the ASEAN Secretary by 3 May 2013 c) Post market activities The Medical Device Adverse Event Report Form and the Medical Device Field Safety Corrective Action Form has been recommended for adoption. 29) The Meeting requested the Member States to coordinate at the national level for the attendance of the industry observers at the MDTC meeting 30) The Meeting endorsed the Report of the 8 th MDTC Meeting held on 24 April 2013 in Petaling Jaya, Malaysia. AGENDA ITEM 7: NEW AREAS FOR DISCUSSION IN MEDICAL DEVICE SECTOR UNDER THE HARMONIZATION EFFORTS 7.1 REFURBISHED MEDICAL DEVICES

5 31) Malaysia presented the approaches for refurbished medical devices in Malaysia as stipulated in the Medical Device Act 2012 (Act 737). 32) The Meeting noted that the medical device reburbishment activities are not only done by original medical device manufacturer and may change the performance, safety, specification and /or medical device or system and may change its intended use. This may have consequence in public health and safety and hence needs to be regulated 33) The Meeting noted that Malaysia is developing the Guidelines for Good Refurbishment Practice for Medical Device (GRPMD) for original medical device manufacturer forrefurbishment of their medical devices. The guidelines are based on the Good refurbishment Practice for Medical Imaging Equipment of the European Coordination Committee of the Radio Electromedical and Healthcare IT Industry (COCIR), Japan Industries Association of Radiological Systems (JIRA) and Medical Imaging & Technology Alliance a Division of NEMA The National Electrical Manufacturer Association (MITA). 34) The Meeting also noted that Malaysia has established a committee to coordinate the organization of Seminar on Medical Device Refurbishment in Malaysia to create awareness on refurbished medical devices 35) The Meeting requested Malaysia to share the draft GRPMD and the documents from COCIR, JIRA and MITA with the Member States for information. 36) Indonesia informed the meeting that refurbished medical devices are not regulated under the Ministry of Health Decree. 37) Singapore informed the Meeting that refurbishment of medical devices is allowed based on the definition of refurbished medical devices. 38) Philippines informed the Meeting that guidelines for refurbishment medical devices are being developed and agreed to share the draft guidelines with the Member States. 39) The Meeting agreed to continue to share information on approaches in Member States for Refurbished Medical Device in future meeting. 7.2 IN-VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs) 40) Singapore briefed the Meeting on the preparation of product registration submission for in-vitro diagnostic medical device using the ACDST. 41) The Meeting noted that the ACDST for IVDs differ from the ACDST for medical devices in pre-clinical testing which covers a summary and overview of the IVD test kits, labeling requirements, risk analysis and manufacturing information. 42) The Meeting requested the Member States to review the ACSDT for IVDs and provide the comments to Singapore by 30 June AGENDA ITEM 8: NOMEDCLATURE OF MEDICAL DEVICES 43) Indonesia informed the Meeting that a specific nomenclature for medical devices has not been adopted at the national level. However, Indonesia has adopted the HS code for Medical Device, to support the implementation of the Indonesia National Single Window (NSW) which will be connected to ASEAN Single Window (ASW).

6 44) Thailand informed that Meeting that a specific nomenclature for medical devices has not been adopted at the national level. 45) The representative from MIMOS Malaysia made a presentation on the recent development in medical device nomenclature harmonization. 46) The Meeting noted that initiatives of the GMDN and UMDS in correlation of their nomenclature with other relevant nomenclature related to clinical terminology (SNOMED), international classification of diseases (ICD-10) and universal code system for identifying laboratory and clinical observations (LOINC). 47) The Meeting agreed to continue to share regular updates on initiatives medical devices nomenclature. AGENDA ITEM 9: COOPERATION WITH INTERNATIONAL AND REGIONAL 9.1 COOPERATION WITH INTERNATIONAL MEDICAL DEVICE REGULATORY 48) Singapore updated the Meeting on the progress made in the IMDRF on activities related to medical device regulations. 49) The Meeting noted the 3 rd IMDRF Meeting was held on March 2013 in Nice, France. The Meeting noted that the Management Committee of the IMDRF comprises regulators from Australia, Brazil, Canada, China, European Union, Japan and United States of America. The World Health Organization (WHO) is an official observer regulators from Russian Federation and Mexico are invited observers and the Asian Harmonization Working party (AHWP) is an Affiliate Organization. 50) The meeting noted the following work items under consideration by the IMDRF a) Review of the national Competent Authorities Report Exchange Program b) Roadmap for implementation of Unique Device Identification System c) Medical Device Single Audit Program d) List of Recognized Standards e) Regulated Product Submission f) New work items Medical Device Single Audit Program Assessment Program and Auditing Strategy of Medical Device recognized Auditing Oranization Assessor Competency and training requirement for Regulatory Authorities undertaking assessments of Auditing Organizations 51) The Meeting noted that the 4 th IMDRF Meeting will be held on November 2013 in Brussels, Belgium. 9.2 COOPERATION WITH WORLD HEALTH ORGANIZATION (WHO) 52) The Meeting recalled that during the 14 th MDPWG Meeting the representative from WHO proposed support for the ASEAN Member States to build capacity in the medical device regulations. The Meeting also noted that the WHO had indicated the possibility of bi-regional initiatives between South East Asia Regional Office (SEARO) and WPRO to ensure that all ASEAN Member States are covered in the proposed technical assistance program. 53) The Meeting also noted that the WHO agreed to coordinate with the US for the technical assistance for medical devices noting that the US is also providing technical support to the ASEAN Member States in this sector.

7 54) The Meeting agreed to follow-up with WHO for the technical assistance in the medical device sector noting that WHO also participates in the IMDRF. AGENDA ITEM 10: TECHNICAL ASSISTANCE AND COOPERATION WITH DIALOGUE PARTNERS 55) The ASEAN Secretariat briefed the meeting on the progress made with the technical assistance programme to support the implementation of the ASEAN Medical Device Directive under the ASEAN US Enhanced Partnership. 56) The Representative from the US Department of Commerce briefed the Meeting on the progress made with the ASEAN-US cooperation in the medical device sector. The Meeting noted that the US gad submitted the Concept Note on the Medical Devices Regulatory jarmonization Training Program in Support of ASEAN US Enhanced Partnership and ACCSQ and ASEAN-wide Training and Training in three ASEAN Member States funded by the USAID, US State Department and the industry. 57) The Meeting noted that the objective of the proposed training program outlined in this Concept Note is to assist ASEAN Member States to develop and implement the AMDD. The ASEAN wide training US Workshop on Medical Devices Regulatory Harmonization Training Program was held on April ) The Meeting was also informed that the national training will be held in 2013 as follows: a) Indonesia August for regulators and August for Industry b) Thailand August for regulators and 23 August for industry Cambodia, Lao PDR and Myanmar will also be invited c) Vietnam late July for regulators and industry 59) The US informed the Meeting that to assist with organization of trainings in 2014 the Member States could provide more information on the priorities for training. In this regard, the Meeting requested the US to align the trainings with the proposed Roadmap for the implementation of the AMDD. 60) The Meeting shared views on the selection of topics and trainers with the US for consideration when organizing future workshops. The Meeting suggested that the workshops should cover specific topics as apposed to a wide range of topics with more depth and with case studies. The Meeting also agreed to collate all the presentation materials and share them with the stakeholders. 61) The Meeting expressed appreciation to the US Department of Commerce for the cooperation and continued support in the medical device sector in ASEAN. AGENDA ITEM 11: OTHER MATTERS 11.1 MDPWG TRUST FUND 62) The ASEAN Secretariat informed the Meeting that the balance of the MDPWG Trust Fund amounting to US 1978 has been used to reimburse the flight and accommodation of the Myanmar delegate who attended the 16 th MDPWG Meeting.

8 63) The Meeting agreed to close the MDPWG Trust Fund. AGENDA ITEM 12: WORK PROGRAMME 64) The Meeting reviewed and revised the Work Programme of the MDPWG taking into consideration the progress made with the activities of the MDPWG. AGENDA ITEM 13: Date and Venue of the next meeting 65) The Meeting reviewed the List of MDPWG Meeting which appears as below: NO. MEETING NO. DATES VENUE 1 1 st MDPWG Meeting 3-4 March 2005 Kuala Lumpur, Malaysia 2 2 nd MDPWG Meeting July 2005 Jakarta, Indonesia 3 3 rd MDPWG Meeting February 2006 Chiang Mai, Thailand 4 4 th MDPWG Meeting July 2006 Bandar Seri Begawan, Brunei Darussalam 5 5 th MDPWG Meeting January 2007 Singapore 6 6 th MDPWG Meeting 30 July 2 August 2007 Hanoi, Viet Nam 7 7 th MDPWG Meeting January 2008 Manila, Philippines 8 8 th MDPWG Meeting July 2008 Bali, Indonesia 9 9 th MDPWG Meeting 30 March 3 April 2009 Penang, Malaysia th MDPWG Meeting October 2009 Vientiane, Lao PDR th MDPWG Meeting April 2010 ASEAN Secretariat th MDPWG Meeting October 2010 Manila, Philippines th MDPWG Meeting April 2011 Siem Reap, Cambodia th MDPWG Meeting October 2011 Hanoi, Viet Nam th MDPWG Meeting April 2012 Phuket, Thailand th MDPWG Meeting 8-12 October 2012 Yogyakarta, Indonesia th MDPWG Meeting April 2013 Petaling Jaya, Malaysia th MDPWG Meeting September 2013 Brunei Darussalam th MDPWG Meeting April 2014 Singapore

9 66) The Meeting agreed to request Brunei Darussalam to consider hosting the 18 th MDPWG Meeting in the end of October 2013 Brunei Darussalam agreed to consult the relevant authorities and confirm the date and exact venue of the 18 th MDPWG Meeting through the ASEAN Secretariat. 67) The Meeting also requested Singapore to consider hosting 19 th MDPWG Meeting during the first half of AGENDA ITEM 14: ADOPTION OF REPORT 68) The Meeting considered and adopted the Report of the 17 th Medical Device Product Working Group Meeting held on April 2013 in Petaling Jaya, Malaysia. Summarized by: Preecha Bhandtivej