Registering Medical Device in India
With medical development in India and more devices being manufactured in India, the Indian Government has bought a change in the law concerning medical devices. Through the Drugs and Cosmetics Act, 1940 (DCA) and Medical Devices Rules, 2017 (MDR), the Indian Government-regulated 37 categories of medical devices where the manufacture and importer of those medical devices requires a license for those devices. Meanwhile, the change bought by the government notes that from now the manufacturers and importers of all medical devices (other than 37 as well) will be required to have the license for the manufacture. The date for the same was October 1, 2021, and if the device is manufactured or licensed without registration after the said date, will be deemed to be illegal. This will violate DCA and MDR and the only option is to stop the manufacturing and wait till the registration is done.
Before getting further, it is important to understand the definition of Medical Device that has been mentioned under MDR-
All devices including an instrument, apparatus, appliance, implant, material, or another article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation, or assistance for, any injury or disability;
(iii) investigation, replacement or modification, or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception
Medical Device registration
Central Drug Standard Control Organization (CDSCO) is the principal institution that oversees medical device regulation. A part of the Ministry of Health and Family Welfare, this institute is responsible for the regulation of all medical device registration in India. The classification has been done in four categories under Class A, Class B, Class C, Class D. The Classes are categorized in terms of being risky where Class A being the lowest risk and Class D being the highest risk.
Appoint the agent who is authorized for working with CDSCO who must have a valid license under Forms 20B and 21B/21C. Obtaining the Power of Attorney is important as it helps the agent to work on behalf of the client. Some of the medical devices in India such as In-Vitro diagnostic devices requires performance test which is done by the National Institute of Biologicals. The process starts with the filing of Form MD-15 where the agent will include the device’s technical information manufacturing facility information (to register the facility/facilities being used to produce the device), ISO 13485 certificate, IFU, and any testing results and clinical data.
Also, in case, if the registration is already done in other different countries such as the United States, Australia, Canada, European Union, etc. then proof of approval can also be added. After getting the application done, the finalized application must be sent to CDSCO with the requisite application fees. In case, the application requires a review of the Subject Expert Committee, then it can be also be requested. And finally, after passing all the conditions, the registration certificate will be issued.
Also, the existence of ISO 13485 certificate by the certification body accredited with the National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) will be beneficial. Also, the accessories to the medical device will be subject to registration only when they qualify for being a medical device.