Indian regulators add to list of notified devices, formulate QMS requirements for medical devices

By Stewart Eisenhart, Emergo Group

Advisors to the Indian government have proposed adding certain product types to the country’s list of notified devices, as well as implementing high-level quality management system requirements for medical devices manufactured and registered for sale in the country.

At an August 20 2015 meeting of the Drugs Technical Advisory Board (DTAB), an entity that provides advice to India’s government on issues related to pharmaceuticals and medical devices, DTAB board members agreed upon changes to the country’s Drugs and Cosmetic Rules of 1945 that would add more specific quality system requirements for domestic medical device manufacturers. The board also agreed to add endometrial ablation devices to India’s list of notified devices, which would subject these products toCDSCO regulation.

It should be emphasized that the issues discussed during the DTAB meeting must still go through additional steps before final regulations are set: the Ministry of Health and Family Welfare must weigh in on the DTAB recommendations, followed by the Indian Legal Department. Then industry feedback must be solicited prior to publication of any final regulations or clarification letters.

QMS proposals
According to Emergo consultants attending the meeting, Schedule M-III, as the DTAB calls the quality system proposal, would apply to manufacturers of medical devices as well as IVD reagents and kits. The schedule lists requirements covering the following areas:

Design and development	Labeling
Manufacturer	Testing
Packaging	Installation and servicing

Furthermore, the quality management requirements would apply to the following device types:

Finished medical devices	Surgical dressings
IVD products	Surgical staplers
Surgical bandages	Surgical sutures and ligatures
Mechanical contraceptives	Blood and blood component collection bags

Manufacturers that would have to comply with these rules would also be required to prepare and maintain both site master files and device master files.

Importantly, the quality management proposals would apply only to devices notified with the Indian Central Drugs Standard Control Organization (CDSCO).

New notified devices
DTAB members also agreed to add endometrial ablation devices to the list of notified devices subject to regulation by CDSCO. These products are currently imported into India without any registration or import licensing requirements.

DTAB members also indicated that heart lung packs, custom tubing and perfusion packs are categorized under “Disposable Perfusion Sets,” a notified group of devices also subject to CDSCO regulation.

However, the board members acknowledged that a clarification letter should be issued in order to confirm their status as notified products, and prevent hurdles during the importation process.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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