Last Updated on September 28, 2021 by The Health Master
Download DCGI’s guidelines on registration of Medical Devices: The national drug regulator has assured the medical devices industry that the registration of medical devices will be beneficial for the industry itself and will help the regulator to pull out details of products if there are complaints registered by the users or hospitals.
The transition of the medical devices regulation, from classification of the devices to licensing, would be smooth and the regulator will hand hold the industry in the initial stages.
The Drug Controller General of India (DCGI), Dr V G Somani, spoke to the industry members in a recent interaction with the medical devices industry organised by the Association of Indian Medical Device Industry (AiMeD) and supported by Consultants Consortium of Chennai and IIT Kanpur, at a time when the voluntary registration for Class A & B medical devices comes to an end by September 30, 2021.
According to sources, the regulator during the meeting assured the industry that the government is committed to see that supply chain and business continuity is not disturbed and access to medical products will remain priority.
The procedure for the compulsory registration will be the same as it was in the voluntary registration, 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.
If there is a complaint from the users or hospitals on the device, the regulator will identify the products, have the details to start an audit or investigation into such products, for the safety of the public and patients.
The action will be based on complaints and initially there will not be compulsory inspection or verification, said the official, according to those who participated in the meeting.
The DCGI has recently published a guideline to help the industry with the registration of medical devices.
It said that the 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 of Class A and B 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 of Class C and D 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.
During the licensing regime, the class A & B will be regulated by the State Licensing Authority and the notified bodies, while C&D will be regulated by the CDSCO, for which there would be compulsory inspection.