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- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
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Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR/in Latest Updates, Philippines/by Charmaine Roson
Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.
Vietnam’s DMEC Provides Update on Issuance of C/D Licenses/in Latest Updates, Vietnam/by David Vo
On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
Philippines FDA Publishes Revised Draft of New IVD Regulations/in Latest Updates, Philippines/by Charmaine Roson
The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.
Taiwan’s New TCP III in Effect as of January 1, 2022/in Latest Updates, Taiwan/by Eric Leung
The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Hong Kong to Pilot Prioritizing Some Listed Medical Devices/in Commercial Services, Hong Kong, Latest Updates/by Eric Leung
Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
How New EU MDR Requirements Will Affect Registrations in Asia/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan Gilburg
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Thai FDA Implements Initial Screening Step to Submission Process/in Latest Updates, Thailand/by Bryan Gilburg
Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue/in Indonesia, Latest Updates/by Ilham Hidayattulah
On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,