Govt to regulate ultrasound machines and imaging equipment to address concerns of patient safety

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In order to regulate import, manufacturing, distribution and sale of medical devices, government is mulling to include organ preservative solution, ultrasound equipment and similar imaging equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act (D&C Act, 1940).

Inclusion of separate form for issuing test reports other than manufacturers like the procurement agencies among others and proposal to notify Kamarajar Port Ltd, Chennai, Tamil Nadu and Mundra Port, Kutch, Gujarat; for import and export of pharmaceuticals is also under consideration.

“We are pleased to note that the union health ministry is planning to regulate ultrasound machines and possibly other related imaging equipment under the new Medical Device Rules (MDR) 2017. This is a good move to address concerns of patient safety and calibration to assure quality of these medical equipment specifically because many preowned medical electronics equipment are entering the country via imports without any safeguards,” according to Rajiv Nath, Forum Coordinator, Association of Indian Manufacturers of Medical Devices (AiMeD).

He further adds, “Therefore these imports need to be restricted till we have robust regulations. We had given a list of 31 medical electronics equipment that need to be regulated in a phased manner with adequate transition period to permit preparedness for compliance by regulators, manufacturers and importers. The drugs act is not justified for such medical electronics and the union health ministry need to urgently table the draft bill for stake holders consultation and push for regulations.”

Medical Devices Rules 2017 were notified last year and is in effect since January 1, 2018. The training programme was initiated on the directions of Maharashtra FDA Minister Girish Bapat and Madan Yerawar, Minister of State for FDA in pursuance of the importance of the subject.

New Medical Devices Rules 2017 cover not only medical devices but also in vitro diagnostics. It also includes disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new standards for requirement for manufacture of medical devices. Depending on the risk involved, Central Licensing Authority has classified the Medical devices into four classes i.e Class A, Class B, Class C and Class D.

As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices. Manufacturers are required to apply through national portal of central licensing authority for licensing. For class A and class B medical devices licence will be issued by the state licensing authority and for Class C and Class D licences will be granted by the central licensing authority.

The Medical Device Rules, 2017 are set out to regulate all aspects and activities pertaining to medical devices, namely manufacture of medical devices for sale or distribution, import of medical devices, labelling of medical devices, conducting clinical investigation of medical devices, import/manufacture of medical devices which do not have a predicate device, registration of laboratories for carrying out test or evaluation of medical devices, sale of medical devices, recall of medical devices and export of medical devices.

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