A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.
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.
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.
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.
Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.
UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
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.
The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).
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