India is one of the largest medical devices markets in the world. Since 2005, there are certain types and classes of medical devices registration procedures under the provisions of the Drugs and Cosmetics Rules.

Until January 2017, India’s Ministry of Health and Family Welfare released the Medical Device Rules, in order to develop medical device manufacturing by easing the industry from different sectors. The new rules will take effect on January 1, 2018.

It includes: Clinical trials will be subject to two-phase process instead of four. Physical damages due to trials are eligible for compensation. Moreover, medical device manufacturing will be reconstructed, by bringing industrial practices in line with international standards. Except for pushing drug regulations on the sector, the new rules are expected to foster a local medical device production industry.

The government categorized the outsourced auditing manufacturers as Class A and Class B. Notified bodies, which could be “any institutes, organizations or body corporations”, can audit the manufacturers to verify their conformance with the quality management system. The notified bodies should be accredited by the National Accreditation Body, which could itself be an outside firm or institute appointed by the government.

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