The Central Drugs Standard Control Organisation on 21st September 2021 has notifed the steps to be followed by the manufacturers/importers for registration of non-notified medical devices.
As per the Medical Device Rules, 2020, there shall be a voluntary registration of all non-Notified medical devices over an 18-month period with the Central Drugs Standard Control Organization. After the voluntary period (i.e., from October 1, 2021) all class A and B devices would have another 12 months to be registered (i.e., by October 1, 2022) in the CDSCO’s on-line portal. Class C and D devices would have another 24 months to meet the same requirement (i.e., by October 1, 2023).
The Manufacture, while registrating the medical device shall state the medical device Generic Name, model number, intended use, class of medical device, brand name etc and the Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device shall be submitted along with an undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
The importers shall mention the Specification and standards of the medical devices and the Free sale certificate from country of origin and an undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.