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ASEAN Medical Devices Regulation - infodent.com

Infodent International1/2012 60certificates & regulationsASEAN Medical Devices RegulationThe Association of Southeast Asian Nations ( ASEAN ) represents a group of 10 countries in Southeast Asia comprising Indonesia, Singapore, Malaysia, the Philippines, Thailand, Brunei, Cambodia, vietnam , Laos and Myanmar, with a combined population of about 600 million people and strong regional economic growth of average 7% annually. ASE-AN s goal is to unify the region into a single trading bloc through the creation of the ASEAN Economic Community by 2015. Up to now, ASEAN has completed of measures planned for Phase I (2008-09) and Phase II (2010-11) of the AEC Blueprint. The requi-red steps include eliminating trade and investment barriers and harmonizing industry regulations, and within this framework, he-althcare is one of the priority industries identi ed to drive regional integration. At present, Medical Devices regulations or general guidelines are in place in Singapore, Malaysia, Indonesia, Thailand, vietnam , the Philippines and Myanmar.

Infodent International 1/2012 62 certificates & regulations Malaysia, Singapore Thailand Philippines Indonesia Vietnam Cambodia Myanmar Lao PDR China Chinese Taipei

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Transcription of ASEAN Medical Devices Regulation - infodent.com

1 Infodent International1/2012 60certificates & regulationsASEAN Medical Devices RegulationThe Association of Southeast Asian Nations ( ASEAN ) represents a group of 10 countries in Southeast Asia comprising Indonesia, Singapore, Malaysia, the Philippines, Thailand, Brunei, Cambodia, vietnam , Laos and Myanmar, with a combined population of about 600 million people and strong regional economic growth of average 7% annually. ASE-AN s goal is to unify the region into a single trading bloc through the creation of the ASEAN Economic Community by 2015. Up to now, ASEAN has completed of measures planned for Phase I (2008-09) and Phase II (2010-11) of the AEC Blueprint. The requi-red steps include eliminating trade and investment barriers and harmonizing industry regulations, and within this framework, he-althcare is one of the priority industries identi ed to drive regional integration. At present, Medical Devices regulations or general guidelines are in place in Singapore, Malaysia, Indonesia, Thailand, vietnam , the Philippines and Myanmar.

2 In the remaining three countries, Brunei, Cambodia, and Laos, they are still under development. However, regulations currently in force do not necessarily imply the manda-tory registration of Medical Devices for sale, such as in the case of the ASEAN Roadmap for Healthcare Integration, Medical Devices regulations and standards across all member countries, as well as pre-market approval process and post-marketing surveil-lance system will be harmonized in a comprehensive this purpose, the Medical Device Product Working Group (MDPWG) was created in January 2005 as one of the 12 working groups of the ASEAN Consultative Committee for Standards and Quality (ACCSQ), to create a uni ed Medical device Regulation known as the ASEAN Medical Device Directive (AMDD), coordina-ting the e orts on technical harmonization with the Asian Harmo-nization Working Party and the Global Harmonization Task Force.

3 Currently, the second AMDD draft is being reviewed by regulators who also called for industry comments, and is expected to be na-lized by 2013. AMDD won t be a law in itself, but member countries will have to transpose it in the national legislation by requirements are basically the same as GHTF requirements as regards Medical device de nition, risk classi cation system (classes I-IV), and Essential Requirements of Safety and Performance (ERSP), while Clinical trial safety requirements are based on the Helsinki Declaration of 1964. In vitro diagnostics are also considered as me-dical International 1/2012certificates & regulationsAMDD provisions shall include:- A common submission dossier template (CSDT) for product approval (the counterpart of the GHTF s Summary Technical Documentation, plus some items added to device description) including samples of labelling, packaging ma-terials and full instructions;- Declaration of Conformity stating compliance with the ERSP and listing device name, appli-cable standards, location of test results, manu-facturer information and responsible person (local clinical trials should not be required for Class I and II Devices , but only for some Class III or IV Devices );- Conformity assessment review of quality management and post-market surveillance;- Post-marketing alert system for adverse events reports and identi cation of defective or unsafe Devices .

4 - Unsolved issues include language require-ments, whether English or local, and the use of third-party, independent bodies for confor-mity foreign company applying for Medical de-vice approval must have a local o ce or local agent in the ASEAN country of application, be it a branch o ce, subsidiary, or independent distributor, to act as the legal responsible for the device. Further to the implementation of the AMDD, some measures to facilitate over-seas applications are under discussion, such as the standardization of approval process and the mutual recognition of product appro-vals across ASEAN countries. These provisions would imply the use of the same dossier tem-plate and standards, thus sparing companies from submitting separate applications in each ASEAN country. However, this would not mean that the registered product has automatic appro-val in all ASEAN countries, as only those with more advanced regulatory systems would be granted this possibility.

5 Even now, that no such recognition system exists, companies that register their products in Singapore before applying in other countries are advantaged, as Singapore has one of the most developed regulatory systems in the AMDD is also going to target the storage and distribution cycle through a system of Good Distribution Practice for Medical Devices (GDPMDS), which is already in place in Singapore and partly in Indonesia. Infodent International 1/2012 62certificates & regulationsMalaysia, SingaporeThailandPhilippinesIndonesiaVie tnamCambodiaMyanmarLao PDRC hinaChinese TaipeiSouth KoreaHong KongMalaysia, SingaporeThailandPhilippinesdonesiaInfor mation required to demonstrate conformity to Essential Requirementsof Safety and Performance (ERSP) among Asian EconomiesSummary Technical Documentation (STED) (the amount of data depends on the complexity and risk class of the device)All technical documents relating to safety, product e cacy and quality Notarized declaration of conformity with international/national standard Information on QS, product standard and certi cate of analysis for nished product Risk assessment & clinical trials for certain Medical Devices GMP/ISO cert, company & master plan le, SOP, QMS documentation Characteristics of Medical device, information on quality, standard & analytical procedure,certi cate of analysis or certi cate of testing from the manufacturer No Medical device regulatory in place yetInformation/documentation from the manufacturer to demonstrate conformity, including the design document, testing report, clinical trial data, etc Technical documents including design, material, standards, test results, clinical reports, label, certi cate from foreign government, quality manual and procedures to demonstrate compliance with GMP.

6 License of the pharmaceutical manufacturer/distributor GMP conformity assessment application form; copy of license for manufacturing /importing; quality management documents (Quality manual, product master le, etc.)Is developing conformity assessment framework including requirements on information and documentationSource: Harmonization of Medical Devices Regulation in the ASEAN Region


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