Some of the salient features of the Medical Devices Rules, 2017 (‘MD Rules’) notified by the Ministry of Health and Family Welfare (‘MHFW’) on January 31, 2017, which will come into force from January 1, 2018, are set out below:

i. Definition of Medical Device: The term ‘medical device’ has been defined to mean: “(a) 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) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (‘DCA’); (b) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii) of clause (b) of Section 3 of the DCA; and (c) devices notified from time to time by the Central Government under sub-clause (iv) of clause (b) of Section 3 of the DCA”;

ii. Classification of medical devices: The MD Rules provide for a risk based classification: (a) low risk as Class A; (b) low moderate risk as Class B; (c) moderate high risk as Class C; and (d) high risk as Class D;

iii. Conformance to the Bureau of Indian Standards or MHFW standards: Where no relevant standards have been laid down, such device should conform to the standards laid down by the International Organisation for Standardisation or the International Electro Technical Commission, or as per any other pharmacopoeial standards. In the absence of the above standards, the device should conform to the validated manufacturer’s standards;

iv. Licensing Mechanism: Licenses for manufacture for sale or for distribution of devices falling under Classes A and B will be granted by the State Licensing Authority, whereas, those falling under Classes C and D and import licenses all classes of medical devices will be granted by the Central Licensing Authority;

v. Term of Licenses: Any new licenses obtained under the MD Rules, whether for manufacture or import, will be valid in perpetuity, unless cancelled or surrendered and provided requisite license retention fees are paid; and

vi. Shelf Life: This will be determined keeping in view the technical parameters and will ordinarily not exceed 60 months from date of manufacture. The MD Rules also contain restrictions on the import of certain medical devices depending on their respective shelf life claim and the percentage of residual shelf-life as on the date of import.