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India Grants Import License Grace Period for Class C/D Devices
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.
Indonesia to Require Post-Market In-Country Testing of Medical Devices
Indonesia’s Ministry of Health announced that as of September 2023 certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.
China’s NMPA Updates Medical Device Classification Catalogue
China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
Thai FDA Drafting New Guidance for SaMD and AI Device Registration
Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.
China NMPA Adds 47 Products to Clinical Trial Exemption List
China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.