December 20, 2019

NITI Aayog proposes to bring all medical devices under single regulatory regime

[ by Kavita Krishnan ]


NITI Aayog has proposed to bring all medical devices under one regulatory regime in a phased manner and have a separate Medical Devices Administration (MDA) with four divisions.

The NITI Aayog is a policy think tank of the Government of India, established with the aim to achieve sustainable development goals with cooperative federalism by fostering the involvement of State Governments of India in the economic policy-making process using a bottom-up approach.

In a stakeholders’ meeting in New Delhi, the NITI Aayog discussed the key features of the draft Medical Devices Bill. The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licenses to register a medical device or get a certificate of compliance.

The government is proposing to have a National Register of Medical Devices. These devices are presently governed by the Drugs and Cosmetics Act, 1940. Experts expect the proposed bill to be notified within the next six months.

The Medical Devices Authority would be a parallel vertical to the Central Drugs Standard Control Organization (CDSCO) and would be under the Directorate General of Health Services (DGHS), as per the proposal of NITI Aayog.

In the draft Bill, the NITI Aayog has proposed to have four separate divisions under the new Medical Devices Administration — (a) health and safety division; (b) conformity assessment division; (c) enforcement division; (d) the laboratories and medical devices testing division.

The health and safety division would grant permission for clinical investigation on human subjects, specify and evaluate the clinical evidence, collect and analyze results of the post-market surveillance.

The draft Bill has also proposed several penalties in case of non-adherence to the new Act. Existing medical devices will have a window of 12-36 months (depending on the device class) from the date the new Act comes into force for registration.

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