Asean Medical Device Working Group

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ASEAN Medical Device Committee (AMDC) - HSA

https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/amdc

The ASEAN Medical Device Committee (AMDC) was formed in 2014 to coordinate the implementation of the ASEAN Medical Device Directive (AMDD), an …

Standard and Conformance - ASEAN Main Portal

https://asean.org/our-communities/economic-community/standard-and-conformance/

1. ASEAN Agreement on Medical Device Directive (2014) Interpretative Notes for AMDD; Annex 1: Essential Principles of Safety and Performance of Medical Devices; Annex 2: …

ASEAN Consultative Committee for Standards

https://asean.org/wp-content/uploads/images/archive/SnC/ASEAN%20MDPWG%20CSDT_Final_21%20Oct%202010.pdf

ACCSQ MEDICAL DEVICE PRODUCT WORKING GROUP Page 5 of 12 conditions under which the device should not be used because the risk of use clearly outweighs any …

Home | GHWP

http://www.ahwp.info/

Work Group 3 (WG3) - Pre-market: Software as a Medical Device; Work Group 4 (WG4) - Post-Market; Work Group 5 (WG5) - Clinical Evidence for Performance …

MEDICAL DEVICE GUIDANCE - Home - ASEAN …

https://www.asean.org/wp-content/uploads/images/archive/SnC/Guidance%20to%20ASEAN%20CSDT_Final_21%20Oct%202010.pdf

The ASEAN CSDT document contains elements of the GHTF guidance document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential …

ASEAN Medical Device Directive

https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

ASEAN Medical Device Directive

Key Documents and Publications - ASEAN Main Portal

https://asean.org/our-communities/economic-community/standard-and-conformance/key-documents-publications/

2. Working Group 2 – Conformity Assessment. Guidelines for Implementation of Harmonised Accreditation in ASEAN; ASEAN Guidelines for Accreditation and Conformity …

ASEAN Countries Could Be the Next Emerging …

https://www.mddionline.com/business/asean-countries-could-be-next-emerging-medtech-markets

The classification system, based on Global Harmonization Task Force (GHTF) guidelines, consists of four medical device categories: Class A includes low-risk devices, such as tongue depressors. Class B …

Committees & Working Groups - AdvaMed

https://www.advamed.org/member-center/committees-working-groups/

The LatAm Regulatory Working Group advances AdvaMed’s LatAm regional regulatory work including a priority on the implementation of foundational good regulatory practices and medical device specific regulatory …

Key Industries for Investment in ASEAN - ASEAN …

https://www.aseanbriefing.com/news/key-industries-investment-asean/

As ASEAN’s de facto commercial center, its highly educated workforce, reliable business environment and transparent legal and tax regimes have ensured that Singapore remains a popular destination for …

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ASEAN Medical Device Committee (AMDC) - HSA

Standard and Conformance - ASEAN Main Portal

ASEAN Consultative Committee for Standards

Home | GHWP

MEDICAL DEVICE GUIDANCE - Home - ASEAN …

ASEAN Medical Device Directive

Key Documents and Publications - ASEAN Main Portal

ASEAN Countries Could Be the Next Emerging …

Committees & Working Groups - AdvaMed

Key Industries for Investment in ASEAN - ASEAN …

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