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- 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
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
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Indonesia e-Catalogue Implementation Review, December 2022
/in Indonesia, Latest Updates/by Ilham HidayattulahOn 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 VoOn 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 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.