DCGI asks State FDAs to ensure uninterrupted supply of Medical Devices

Registration regime for the Class A & B medical devices in the country, which will be starting from October


Last Updated on October 2, 2021 by The Health Master

The Drugs Controller General (India) has asked the State drug controllers of State FDAs of India to ensure uninterrupted supply of medical devices even as it is considering the medical devices industry’s request regarding relaxation on the deadlines for the registration of the products with the authority.

The move comes closer to the initiation of compulsory registration regime for the Class A & B medical devices in the country, which will be starting from October.

The Central Drugs Standard Control Organisation (CDSCO) has also announced classification of 48 medical devices pertaining to Oncology, 153 devices related to gastroenterology, and another 110 related to neurological therapy.

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.

However, the ministry has received various representations from stakeholders recently informing that complete preparedness of industry in this regard remains to be achieved, in light of disruption due to C-19 pandemic situation.

“The representations are under consideration of the ministry of health and family welfare, Government of India. You are requested to take note of the same with a view to ensure uninterrupted supply of such medical devices and access to the patients till a decision is taken on the representations,” said a letter from Dr V G Somani, Drugs Controller General (India) to all drug controllers.

The industry has raised concerns on the regulation moving to a compulsory registration regime from October, this year, since there are companies yet to register their products. The CDSCO has also published the list of eight notified bodies registered with the Organisation under the Medical Devices Rule, 2017, to carry out audits of manufacturing sites under the provisions of the said rules.

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