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Harmonization Efforts in Asia-Pacific - DIA Global Forum
- https://globalforum.diaglobal.org/issue/april-2021/aligning-combination-products-regulations-in-asia-pacific-a-distant-dream/
- Harmonization Efforts in Asia-Pacific In Asia-Pacific, CP regulations are relatively recent, and specific regulations exist in certain markets only. In addition, across the region there …
ASEAN Medical Device Directive
- https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
- ASEAN Medical Device Directive
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 …
The ASEAN harmonization of technical …
- https://www.raps.org/news-and-articles/news-articles/2021/6/journey-of-the-asean-harmonization-of-technical-st
- The health supplements industry and ASEAN member state regulators should continue the culture of public-private partnership in fostering the success of the …
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: …
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 …
HARMONIZATION OF STANDARDS IN ASEAN
- https://asean.org/harmonization-of-standards-in-asean/
- Basic Principles of Harmonisation. During this harmonisation exercise, the national standards bodies in ASEAN or similar bodies would need to adopt the …
ASEAN Harmonisation of Traditional Medicines and …
- https://www.hsa.gov.sg/international-collaboration/international-collaboration-complementary-health-products/asean
- ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines and Health Supplements ASEAN Guiding …
MEDICAL DEVICES PRODUCT STANDARDS …
- https://www.asean.org/wp-content/uploads/images/archive/SnC/medical_devices_standards_for_harmonisation_ao%2017%20june%202013.pdf
- MEDICAL DEVICES PRODUCT STANDARDS (HARMONISATION STATUS) MEDICAL DEVICES LEGEND MEDICAL DEVICES FIRST PRIORITY 10 Packaging for terminally …
Medical Device Harmonization in Southeast …
- https://www.pacificbridgemedical.com/publication/medical-device-harmonization-in-southeast-asia/
- The MDPWG’s most recent draft regulations — the ASEAN Medical Device Directive (AMDD) — came out in 2012, and implementation is expected by December …
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