All medical equipment notified as drugs

| | New Delhi
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All medical equipment notified as drugs

Sunday, 10 February 2019 | PNS | New Delhi

All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator have been notified as drugs with effect from April 1, 2020, as per a recent notification by the Union Health Ministry.  This aims to regulate medical and diagnostics devices in the country. 

Giving this information here,  officials said these eight medical equipments have been notified as ‘drugs’  under Section 3 of the Drugs and Cosmetics Act.  “In pursuant of sub-clause (IV) of clause (b) of section 3 of the Drugs and Cosmetics Act of 1940, the central government after consultation with the drugs technical advisory board hereby specifies the following devices intended for use in human beings as drugs with effect from the first day of April 2020 namely — all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, xray machine and bone marrow cell separator,” a notification issued on Friday by the Ministry said.

A majority of medical devices are unregulated in India. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework, said the official.

Meanwhile, it is learnt that the Central Drugs Standard Control Organization (CDSCO), the national medical device regulator, is also working to chart out a road map for regulating the sale and use of medical devices.

It recently held a meeting where, a consensus was reached to roll out medical devices regulations in a phased manner and constitution of medical devices - expert advisory group (MD-EAG) to aid Health Ministry in this regard.

These include separate and clear law for regulation of all medical devices in the country; separate medical devices authority (or revamping of CDSCO) in due course; no compromise on quality & safety of medical devices, implementation of defined transition time & competency building measures including infrastructure and training for regulators and industry.

The consensus was also built into registration of all manufacturers and importers of all non notified medical devices at earliest; devices’ labels to carry registration number and address to enable traceability.

Welcoming the move, Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) who was present at the meet hoped that it will create a new regulatory marketing approval system and the government can keep a tab on importers as well as manufacturers. Presently, there’s no data and facts available in this regard which effects the policies.

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