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- Vietnam Clearing Backlog of Medical Device Registration Applications September 16, 2024
- Vietnam Allows Amendments to Registration Applications Under Review September 16, 2024
- Vietnam MoH Audits License Holders for Compliance September 11, 2024
- Thailand Adds Qualified Personnel Requirements for Establishment Licensing August 23, 2024
- Philippines Incentivizes Local Medical Device Manufacturing August 22, 2024
- Hainan Island’s Special Access Program for Medical Devices August 2, 2024
- China Updates Medical Device Clinical Evaluation Pathway Guidance July 29, 2024
- China Releases New List of Standards for Medical Device Registration July 26, 2024
- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
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Vietnam Clearing Backlog of Medical Device Registration Applications
/in Latest Updates, Vietnam/by David VoSurvey of the Vietnam Ministry of Health (MoH) database on May 9, 2024, showed a significant rise in Class C/D medical device processing.
Vietnam Allows Amendments to Registration Applications Under Review
/in Latest Updates, Vietnam/by David VoOn August 16th, 2024, Vietnam MoH introduced new guidance allowing amendments to registration applications under review, enabling document updates during the process.
Vietnam MoH Audits License Holders for Compliance
/in Latest Updates, Vietnam/by David VoAsia Actual Vietnam completed an MoH audit, covering key compliance areas including licensing, documentation, and operational procedures.
Thailand Adds Qualified Personnel Requirements for Establishment Licensing
/in Latest Updates, Thailand/by Noi SuwannabotThailand’s Ministry of Public Health issued a new notification affecting medical device establishment licensing and controller qualifications
Philippines Incentivizes Local Medical Device Manufacturing
/in Latest Updates, Philippines/by Charmaine RosonJuly 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.
Hainan Island’s Special Access Program for Medical Devices
/in China, Latest Updates/by Bryan GilburgOn May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices.
China Updates Medical Device Clinical Evaluation Pathway Guidance
/in China, Latest Updates/by Bryan GilburgIn March of 2024, the CMDE added 25 devices to the “Guidelines for Deciding Whether to Conduct Clinical Trials on Medical Devices”.
China Releases New List of Standards for Medical Device Registration
/in China, Latest Updates/by Bryan GilburgThe NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.