Search Our News
Latest Headlines
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
Blogs by Country
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
Asia Headquarters
116 Changi Road, #04-05
Singapore 419718
+65 8800-3197
Philippines Incentivizing Local Medical Device Manufacturing
/in Latest Updates, Philippines/by Glend LlantadaOn March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.
China’s Third Batch of UDI Implementation Deadline in June
/in China, Latest Updates/by Bryan GilburgReminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
Thai FDA Reduces Application Review Time
/in Latest Updates, Thailand/by Noi SuwannabotOn February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.
Vietnam’s MoH Updates Class C and D Application Requirements
/in Latest Updates, Vietnam/by David VoPer Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.
India Changes Medical Device Application Processing System
/in India, Latest Updates/by Gunjan VermaOn January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
India’s Class C and D Import License Enforcement Deadline Fast-Approaching
/in India, Latest Updates/by Gunjan VermaOn April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close.
Thai FDA QMS Updates to Affect GDP, GMP, and GCP
/in Latest Updates, Thailand/by Noi SuwannabotLast month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.
Hong Kong MDD Adds China and Korea to List of Reference Countries
/in Hong Kong, Latest Updates/by Bryan GilburgStarting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.