India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries

Notification GSR 147(E) Updates Rule 36 of the Medical Device Regulations

On March 4, 2022, the CDSCO released Gazette Notification 147(E), adding the United Kingdom as the sixth reference country in the Indian Medical Device Rules, 2017. This comes on the heels of the United Kingdom leaving the European Union and formalizes the continuance of the CDSCO’s acceptance of products approved in the UK. The CDSCO relies on reference country approvals as a mark of assurance of the device’s safety, quality, and performance and provides faster approvals for devices from, or approved by, a reference country. Products with Reference Country approval will still need to apply for an Import License but will be reviewed quicker and won’t require clinical trials.

Changes to the Current Reference Country Rule

This change is made in Rule 36 of the Medical Device (2nd Amendment) Rules, 2022. Rule 36 addresses the requirements for granting Import License via Form MD-15 by the Central Licensing Authority (CLA). According to the current rule, clinical investigations don’t need to be carried out as part of the MD-15 approval process for medical devices with a free sale certificate issued by the national regulatory authority or other competent authority of Australia, Canada, Japan, European Union Countries, or the United States of America.

With the new amendment the United Kingdom has been added to the above-mentioned names for the purpose of relaxation of Import requirements.

Medical devices without reference country approval, especially for Class C and D licenses are possible but will only be granted after its safety and effectiveness has been established through a local clinical investigation in India, as specified under provision of Chapter VII of the regulations, Medical Devices Rules, 2017.

Products Requiring Registration in India

Currently only 38 types of medical devices (click here for the current requirements) are required to obtain an Import License (Form MD-15) from India’s Central Drugs Standard Control Organization (CDSCO) prior to being placed on the market. Prerequisites for India medical device licensing include:

1. reference country approval, and
2. ISO 13458 certification of the manufacturing facility.

Given the reference country requirements, the registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review.