The Union health ministry has notified the Medical Devices Rules, 2017 which will come into force from January 1, 2018.

These rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).  

As per the newly notified rules, medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

As per the new rule, medical device manufacturers should follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the contemporary scientific and technological knowledge and development, provided that the guidelines to be so specified shall be in conformity with the provisions of the act and these rules.

The medical device should conform to the standards laid down by the Bureau of Indian Standards established under Section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.  Where no relevant standard of any medical device has been laid down under sub-rule (1), such device should conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards. In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device should conform to the validated manufacturer’s standards.