Policy Matter

Regulation of Medical Devices and Equipments

medical-devices

Only 14 categories of the medical devices notified under the Drugs and Cosmetics Act, 1940 and Rules made thereunder are regulated as drugs. The National Pharmaceutical Pricing Authority (NPPA) medical-devicesunder the Department of Pharmaceuticals regulates the pricing of medical devices. The Authority has informed that the pricing of two devices, namely, ‘condom’ and, ‘Intrauterine Device (IUD)’ containing copper is regulated under the provisions of the Drugs Price Control Order, 2013.

As per Notification GSR 690(E) dated 25.09.2015, the medical devices in India are required to conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards. If there are no Bureau of Indian Standards then these need to conform to the International Standards such as International Organization for Standardization, or other International Pharmacopeia Standards and such other standards as may be specified for this purpose. In case, national or international standards are not available, the devices need to conform to the manufacturer’s validated standards. There is, however, no legal requirement to get certification from United States Food and Drug Administration or any other regulator for medical devices/equipment. In order to ensure adherence to quality standards in some cases of procurement particularly of high end equipment, the technical specifications mention United States Food and Drug Administration approval/ certification. The details of all such tenders are not maintained centrally in the Department of Health and Family Welfare.

The current emphasis of the Department of Health and Family Welfare is on strengthening of the existing laboratories. Medical devices are currently tested in the following laboratories:

(i) National Institute of Biologicals, Noida – For testing diagnostic devices viz. HIV, HBsAg and HCV;

(ii) Central Drugs Testing Laboratories, Mumbai – For testing of Intra Uterine Devices viz Cu-T & Tubular Rings which are included in Schedule R to the Drugs and Cosmetics Rules,1945; and

(iii) Central Drugs Testing Laboratories, Chennai – For testing of Condoms.

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