May 11, 2022

Helping to make getting your medical device or in vitro diagnostic (IVD) device testing done a little bit easier, the Drug Controller General of India (DCGI) has announced it has updated the list of medical device testing laboratories (MDTLs) to now include 21 MDTLs registered with the Central Drugs Standard Control Organization (CDSCO). Medical devices and IVDs are regulated by the DCGI within CDSCO, part of the Ministry of Health and Family Welfare.

Under the provisions of India’s Medical Devices Rules, 2017 (MDR 2017), the MDTLs are authorized to conduct medical device testing or evaluation on behalf of the manufacturer.

The addition of three new MDTLs to the list of available testing laboratories should come as welcome news to medical device and IVD device manufacturers doing business in India. Previously, in December 2021, the list included only 18 MDTLs.

Emerging medical device regulations in India

The medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion (USD) and is expected to reach $50 billion (USD) by 2025, according to a recent paper published online in Perspectives in clinical research.

No medical device regulations existed in India prior to 2005. However, today there are registration procedures for certain types of medical devices regulated under the Medical Device Rules. While the list of regulated products is specific, the CDSCO occasionally adds products to the list. Determining if your product is regulated by the CDSCO is the first step to market access in India.

India medical device registration requirements

Manufacturers interested in registering their medical devices in India must supply proof of approval in their home market. Providing further evidence of prior regulatory authorization in the US, Canada, Europe, Australia or Japan can ease some regulatory requirements.

Your technical documentation must be submitted for review by the CDSCO. In addition, you must register all of your device manufacturing facilities.

Learn more about medical device and IVD regulations in India:

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  • Kathryn Burke's picture
    Kathryn Burke

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