India Telegraphs Enforcing Local BIS Standards for Medical Devices

Implementation Would Require Some Products Pass In Country Testing

On February 1, 2022, the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, Govt. of India released a list of Bureau of Indian Standards (BIS) standards applicable to 1,485 medical devices. While not formally enforced at this time, it is expected that the Ministry of Health and Family Welfare (MOHFW) will soon begin enforcing these local standards. Manufacturers should review the recently released standards and ensure their products meet these standards if they have plans for entering the Indian market. Otherwise, in country local testing may be required as part of the Import License application process which may significantly increase costs and time to market. Manufacturers of products that would potentially require in-country testing to BIS standards should consider seeking registration as soon as possible. Additionally, all Class A and B products are required to have an Import License by October 1, 2022.

For a complete list of BIS standards, please see the CDSCO’s Public Notice here.

Implementation Status of BIS Standards

Rule 7 of Medical Device Rules 2017 specifies the requirements for Product Standards for medical devices and that medical devices should conform to the standards laid down by Bureau of Indian Standards (BIS) or the standards notified by the Ministry of Health and Family Welfare (MOHFW) in the Central Government, from time to time. If there are no relevant Standard of any medical device that has been laid down by BIS or notified by MoHFW, device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopeial standards. And in case of the standards which have not been specified by any of the options given above, then the device shall conform to the validated manufacturer’s standards.

Rule 7. Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards. (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.

Rule 7 Enforcement Under Consideration

Even though Rule 7 has been a part of the Indian MDR 2017 from the initial implementation in January 2018, the CDSCO reviewers and signatories have never insisted on any demonstration of conformance to the Indian Standards. In recent months though, there has been on-going discussion from BIS, Department of Pharmaceuticals calling for strengthening of Indian standards. The CDSCO had also recently (Sep 2021) added a link to existing BIS standards on their website which shows that this may be indicative of their plan to implement Rule 7 and check for conformance to BIS Standards, if available.

Medical Device Registration Requirements in India

Currently only 38 types of medical devices 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.  On October 1, 2022 all risk Class A and B medical devices will require an Import License. The same requirement for all risk Class C and D medical devices comes into effect on October 1, 2022.  In the meantime, all non-Notified medical devices are required to be Registered.  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. For more information on the registration process in India, please click here.

Regulatory Alert:

All Class A and B Devices Require Import Licenses beginning October 1, 2022

All Class C and D beginning October 1, 2023

For the latest information on the regulatory process in India, please see our page on the topic here.

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Contact Asia Actual today with any questions on how these additional testing requirements may affect your market access to India.