A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.

India Issues New Sales License Requirement for 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.

India Issues Final Notice Exempting Certain Class A 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.  

India Issues Draft Notification for Exempting Certain Class A Medical Devices

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.

Registering Innovative Medical Devices in India

Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.

India’s CDSCO Temporarily Delays Implementation of UDI Requirements

UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.

Medical Device Advertising Requirements in Asia

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.

How New EU MDR Requirements Will Affect Registrations in Asia

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.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

India Grants Import License Grace Period for Class A/B 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.

India Launches Scheme for Promotion of Medical Device Parks

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).