India: Additional steps for registration of Innovative Medical Devices

ARQon
Sep 30, 2022
2 min read

Updated: Jan 5, 2023

GOVERNMENT AUTHORITY (CDSCO)

The Central Drugs Standard Control Organization (CDSCO), a division of the Directorate General of Health Services of the Ministry of Health & Family Welfare, is in charge of managing medical device registration in India. The National Regulatory Authority (NRA) of India is the CDSCO.

MEDICAL DEVICE STATUS

Since April 1, 2020, all medical devices must be registered under the 1940 Drugs and Cosmetics Act in order to maintain their status as one of the 23 previously notified medical devices. All Class A and B medical devices must have import licenses before being imported as of October 1, 2022. By October 1, 2023, all Class C and D gadgets that haven't already been notified must obtain import licenses. Even though import licenses are not currently necessary for medical equipment, owners must nonetheless register their product(s) through an ePortal within a few days.

PRODUCT CLASSIFICATION

Depending on the level of risk, medical devices are divided into 4 categories: A, B, C, and D. The device classification determines the CDSCO fees for application processing. No matter how the gadget is classified, the application procedure takes 6 to 9 months. Applications for goods that are unable to recognize a predicate device will be deemed "Innovative" and probably take more time.

Once accepted, each manufacturing site receives an Import License (also known as an MD Form 15), which includes a list of the products permitted.

MEDICAL DEVICE REGULATORY PATHWAYS

All medical devices must be registered or have an import license. A complete list of product types that require an import license can be found at the bottom of this page. These "notified" device categories must obtain an import license by submitting a Device Master File (DMF) for each product and a Plant Master File (PMF) for each manufacturing site. Once approved, the medical device will be registered under the import license associated with the primary manufacturing site.

All Class A and Class B medical devices must obtain an import license by October 1, 2022 to maintain market access. The remaining unreported Class C and D devices must obtain an import license by October 1, 2023, and must be registered as non-regulated products in the meantime

Source:

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidance-document-for-Registration-of-Non-Notified-Medical-Devices..pdf