India Changes Medical Device Application Processing System
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
On May 16th, 2024 India’s CDSCO extended allowances for the importation of Class C and D Medical Devices currently under review.
On 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.
Last 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.
The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.
On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.
Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical 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.
The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.
Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.
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