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MEDICAL DEVICE GUIDANCE - Home - ASEAN …
- https://www.asean.org/wp-content/uploads/images/archive/SnC/Guidance%20to%20ASEAN%20CSDT_Final_21%20Oct%202010.pdf
- Product registration applications for medical devices submitted to ASEAN Member States (AMS) must be prepared in the format set out in the CSDT document. This guidance …
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 …
FDA Circular No.2022-008 || Abridged Processing of …
- https://www.fda.gov.ph/fda-circular-no-2022-008-abridged-processing-of-application-for-registration-of-medical-devices-approved-by-the-national-regulatory-authority-of-any-asean-member-country/
- All applications for registration of medical devices approved by the NRA of any ASEAN member country under the AMDD-CSDT requirements shall have an abridged processing …
Asia Medical Device Registration - Pacific …
- https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/
- Asia Medical Device Registration Medical Device Registration in Asia Utilize our intimate industry knowledge and expertise to obtain registration approvals for your …
Thailand Medical Device - International Trade …
- https://www.trade.gov/market-intelligence/thailand-medical-device
- The process to register a medical device can take from 200 – 300 days to receive approval. U.S. companies’ partners, including their local importers and …
ASEAN Medical Device Directive
- https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
- ASEAN Medical Device Directive
Thailand Medical Device Registration and Approval
- https://asiaactual.com/thailand-3/medical-device-registration/
- Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA). The regulatory process is …
Guidelines published for transition in Philippines to ASEAN …
- https://www.emergobyul.com/news/guidelines-released-transition-philippines-asean-harmonized-requirements
- New circular establishes registration of previously exempt medical devices. This year, the FDA of the Philippines published Circular No. 2021-002, which provides …
ASEAN MEDICAL DEVICE DIRECTIVE - Asia Actual
- https://asiaactual.com/wp-content/uploads/2020/11/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
- HAVING regard to the objectives of harmonised medical device regulations, common technical documents and the progress made in implementation. …
ASEAN MEDICAL DEVICE DIRECTIVE
- https://www.access2hc.com/asean-medical-device-directive-where-is-it-now/
- In 2015, the ASEAN Medical Device Directive (AMDD) agreement was signed in by all the 10 ASEAN countries – Brunei, Cambodia, Indonesia, Laos, Malaysia, …
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