Last Updated on October 10, 2024 by The Health Master
Guidelines for registration of Medical Devices
Download the guidance: Medical devices in the Class A and B will fall under the licensing regime in a year from now, on October 1, 2022, while the Class C and D will come under the regime a year after that, according to the Central Drugs Standard Control Organisation (CDSCO).
The document was issued by the Organisation to help the industry which has come out with several related queries, many of them basic FAQs, even as the mandatory registration for Class A and B are expected to start in a few days now.
In a guidance document issued for manufacturers and importers for voluntary and mandatory registration of medical devices, the Organisation said that the registration of Class A, B, C and D devices has been kept voluntary for a period of 18 months with effect from April 1, 2020, till September 30, 2021.
Voluntary registration: Class A and B Medical Devices
Voluntary registration of Class A and B medical devices shall be followed by mandatory registration for 12 months after the 18 months of Voluntary registration period is over, that is up to September 30, 2022.
“From October 1, 2022 Class A & B devices will fall under licensing regime,” said the guidance document.
Voluntary registration: Class C and D Medical Devices
Voluntary registration of Class C and D medical devices shall be followed by mandatory registration for 24 months after 18 months’ voluntary registration period is over that is October 1, 2021 to September 30, 2023. From October 1, 2023 Class C & D devices will fall under licensing regime.
Documents required by the manufactures
Documents required for registration of medical devices by the manufactures include the name and address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device; details of medical device; 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; and an undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
Documents required by the Importers
Documents required for registration of medical devices by the Importers include the name of the company or firm or any other entity importing the medical device; details of medical device; specification and standards of that medical device; 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; and free sale certificate from country of origin.
The guidance document also has detailed steps the manufacturers and importers can follow to register non-notified medical devices.
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