New Delhi : The Drugs Controller General of India (DCGI) is in the process of enhancing capacity for testing medical devices in the country in tandem with its efforts to bring all the medical devices under the regulatory regime. This also comes in line with the demand of the medical devices industry to increase the testing laboratories so that the regulatory compliance will be hastened.
DCGI Dr V G Somani in a notice issued lately said that in order to enhance the testing capacity of medical devices in the country, identification, registration and empanelment of government and private testing laboratories for medical device testing is under consideration as per medical devices Rules, 2017.
The laboratories which have capacity for testing of medical devices and are NABL accredited and interested in the process area to intimate the same to the CDSCO in its email ID, along with details of categories of such medical devices and capacities and capabilities of testing to CDSCO for initiating further examination and communication, added the official.
According to the CDSCO, till August 27, there are 16 medical devices testing laboratories registered with the Organisation in accordance with the provisions of Medical Devices Rules, 2017, to carry out test or evaluation of a medical device on behalf of the manufacturer. The Medical Devices Rules, 2017, to regulate the manufacture, import, sale and distribution of the medical devices came into effect from January 1, 2018.
The industry has earlier sought provision of testing facilities in India to enable manufacturers to demonstrate compliance to regulations under Medical Devices Rules, 2017.
This work needs to be coordinated on a war footing by the ministry of health and family welfare, Department of Pharmaceuticals (DoP) and CDSCO if the deadlines set at August 2022 for Class A&B and August 2023 for Class C&D for initiation of licensing regime to be met, said Association of Indian Medical Device Industry (AiMeD).
“This has been missing so far. We are not even ready for the October 18th deadline for the eight categories,” said Rajiv Nath, forum coordinator, AiMeD.
According to the ministry of health and family welfare’s notification on February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till end of September, 2021. From October 1, 2021, Class A&B Medical Devices will be under compulsory registration scheme up to September, 2022 and Class C&D medical devices will be under compulsory registration scheme up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.
The Ministry, however, has relaxed certain requirements in compliance following the request from the industry. For instance, in a relief to the medical devices industry, especially the micro, small and medium scale (MSME) enterprises, the ministry of health and family welfare is planning to relax the norms related to registration of medical devices with the regulator by allowing more time to comply with the ISO 13485 certification, which a prerequisite to get the registration.
In a relief to the medical devices industry, especially the micro, small and medium scale enterprises, the ministry of health and family welfare is planning to relax the norms related to registration of medical devices with the regulator by allowing more time to comply with the ISO 13485 certification, which a prerequisite to get the registration. A similar relaxation was also announced for medical devices that are imported, through the same amendment.
