Search Our News
Latest Headlines
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- 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
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
Thailand FDA Publishes Guidance for Software as Medical Device
/in Latest Updates, Thailand/by Noi SuwannabotOn December 12th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand.
China NMPA Updates Compulsory Standards for Medical Devices
/in China, Latest Updates/by Bryan GilburgOn November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.
China NMPA Updates Classification of Sodium Hyaluronate Products
/in China, Latest Updates/by Bryan GilburgOn November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
India Issues Final Notice Exempting Certain Class A Medical Devices
/in India, Latest Updates/by Gunjan VermaOn October 14, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.
China’s NMPA Publishes Classification Catalogue Adjustments for Comment
/in China, Latest Updates/by Bryan GilburgOn October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
Thai FDA Fast Track Route for COVID Related Products to Stop
/in Latest Updates, Thailand/by Noi SuwannabotThe TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.
China’s NMPA Begins Issuing Registration Certificates Electronically
/in China, Latest Updates/by Bryan GilburgOn October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
Good Distribution Practice Requirements in Indonesia
/in Indonesia, Latest Updates/by Ilham HidayattulahIn 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.