Medical Devices Will Now Need to Register Under One of Two Routes

On September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021. This Guidance provides manufacturers of non-notified medical devices with the registration requirements applicable until October 1, 2022 for Class A and B devices and October 1, 2023 for Class C and D.

Registration Requirements for Non-Notified Medical Devices

The new registration process for non-notified devices is the same process available under the previous voluntary registration process. The registration process is quick and only requires the manufacturer or their license holder to submit through an online portal which will provide a registration number upon completion. Once the registration number has been received, the manufacturer will need to update their labeling and adhere to post-market surveillance requirements.

Product information needed for the non-notified medical device registration:

• Name of the company or firm or any other entity importing the medical device
• Details of medical such as the generic name, intended use, classification, material, shelf life, etc.
• Specification and standards of that medical device, ISO 13485 certificate
• Free sale certificate from country of origin
• Declaration of Conformity

Notified vs. Non-Notified Medical Devices

India’s CDSCO has been transitioning from The Drugs and Cosmetics Act of 1940 which only required 23 product categories of medical devices obtain approval before marketing. These competent authority-specified products are often referred to as Notified medical devices in the region. Effective April 1, 2020, the CDSCO began expanding the list of Notified products with October 1, 2021 being the first day all medical devices will need to be registered before importation.

Notified devices required a Device Master File (DMF) for each product depending on the intended use, brand name and other factors that can affect Grouping eligibility. Manufacturers of Notified Devices will also need to submit a Plant Master File (PMF) for each manufacturing site. Each manufacturing site will be designated an Import License number with all products manufactured at the site listed under it. For example, new products manufactured at 2 sites will require 2 PMFs and 2 DMFs. As all products become Notified in the next 2 years, it will be important for manufacturers to submit their DMFs and PMFs before the implementation deadlines to ensure market access isn’t lost.

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