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- An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases May 30, 2023
- Vietnam Diagnostic Imaging Center Hosts AI Software Conference May 11, 2023
- India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline April 18, 2023
- China CMDE Supplementary Documents Submission Deadline Extended April 11, 2023
- UDI Labelling Mandatory for Certain Taiwan Medical Devices April 6, 2023
- Philippines FDA Extends CMDN Deadline to 2024 March 31, 2023
- India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses March 20, 2023
- 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
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Indonesia e-Catalogue Implementation Review, December 2022/in Indonesia, Latest Updates/by Ilham Hidayattulah
On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
The Vietnamese MOH Issues Draft Decree to Address Delays/in Latest Updates, Vietnam/by David Vo
On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.
Thailand FDA Publishes Guidance for Software as Medical Device/in Latest Updates, Thailand/by Noi Suwannabot
On 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 Gilburg
On 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 Gilburg
On 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 Verma
On 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 Gilburg
On 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 Suwannabot
The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.