Spicy Tidbits: Medical Devices Regulation Bill formulated

A draft Medical Devices Regulation Bill has been formulated for the classification of such medical devices which may not be covered by the Drugs and Cosmetics Act. The Bill provides for the creation of a Medical Device Regulatory Authority which has been empowered with extensive powers relating to fining and imprisoning defaulters.

With a diverse range and multitude of medical devices are in use, which aremanufactured using a wide variety of technologies with the result that forensuring the safety of the public in the use of medical devices, an entirely
different system and method of regulation from the current national andinternational practices that are being applied for the regulation of drugsand cosmetics is required,” it says on the need for such an act.

Besides looking to harmonise the standards in accordance with the globalnorms to push the export potentials, the bill also seeks to lay downconcrete norms on import of devices and their conformity with the Indianstandards.Standards notified by the Bureau of Indian Standards or other internationalstandards making bodies like International Organization for Standardization(ISO), the International Electrotechnical Commission (IEC), and the International Telecommunication Union (ITU), standards in the IndianPharmacopoeia and other international Pharmacopoeia monographs may beincorporated for harmonization.

The full text of the article can be found here.

One comment.

  1. AvatarLeo Sebastian

    Indian Medical device regulatory bill (IMDRA) draft is in news for quite sometime now. They had put the whole draft in DST site for feedback. SCT, Trivandrum prepared the draft and it is almost fully inspired/copied from USFDA. But the bill is yet to be tabled in the parliament.
    Just coz of lack of regulation of medical devices policy in India, the product we developed should go through clinical trials because DCGI classified it as a drug (though it is a class 1 med device in USFDA which doesnt need a clinical trial)..we wish this draft is implemented as early as possible, though i knw it is going to be just a wishful thinking.


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