Union health ministry releases draft notification to notify all medical devices under D&C Act for effective regulation

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Union health ministry has released a draft notification to notify all medical devices under the Drugs and Cosmetics (D&C) Act, 1940 to effectively regulate them as per the provisions of the said Act and new Medical Devices (MD) Rules, 2017.

As of today, 37 medical device categories have been notified. Earlier, 26 medical devices were notified between 2005 and 2017 which has under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.

In a notification dated February 8 this year, the Union health ministry brought all implantables along with eight new medical equipment like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under the regulatory framework.

The draft notification stipultes to notify all the medical devices under sub-section (b) of section 3 of the D&C Act, 1940 to regulate them as per the provisions of the Act and MD Rules, 2017.

As per the Union health ministry notification, it has been decided to solicit suggestions/comments/objections from the public/stakeholders with regard to the draft notification before its  finalization. The suggestions/comments/objections may be forwarded within 30 days from the date of issue of this notice by email at drugsdiv-mohfw@gov.in or by post to the Union health ministry.

In pursuance of sub-clause (iv) of clause (b) of section 3 of the D&C Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB) has specified medical devices intended for use in human beings or animals as drugs with effect from December 1, 2019.

It has been stipulated that these devices include an instrument, apparatus, appliance, implant, material or other article whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder, diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process.

It also includes supporting or sustaining life, disinfection of medical devices and control of conception.

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