Short title and commencement (1) These rules may be called the Medical Devices Rules, 2017. (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018. 2. Application These rules shall be applicable in respect of, — (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 2 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) 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). 3. Definitions In these rules, unless the context otherwise requires, — (a) "academic clinical study" means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population; (b) "Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940); (c) "active diagnostic medical device" means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity; (d) "active medical device" means a medical device, the operation of which depends on a source of electrical energy or any other source of energy other than the energy generated by human or animal body or gravity; (e) "active therapeutic medical device" means any active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury or handicap; (f) "authorised agent" means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 3 of 248 (g) "body orifice" means any natural opening in a human body including the external surface of any eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy; (h) "Central Licensing Authority" means the Drugs Controller General of India appointed by the Central Government; (i) "central medical devices testing laboratory" means a medical devices laboratory established or designated by the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established for the purpose of section 6 of the Act; (j) "change in the constitution of a licensee" in relation to, — (i) a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa; (ii) a company means— (A) its conversion from a private to a public company, or from a public to a private company; or (B) any change in the ownership of shares of more than fifty per cent, of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause; (k) "clinical evidence" means, in relation to, — (i) an in vitro diagnostic medical device, is all the information derived from specimen collected from human that supports the scientific validity and performance for its intended use; (ii) a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and performance for its intended use; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 4 of 248 (1) "clinical investigation" means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness; (m) "clinical investigation plan" means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation; (n) "clinical performance evaluation" means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance; (o) "clinical research organisation" means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation or clinical performance evaluation; (p) "conformity assessment" means the systematic examination of evidence generated and procedures undertaken, by the manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore conforms to the essential principles of safety and performance for medical devices; (q) "controlling officer" means the officer designated under rule 10; (r) "custom made medical device" means a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device; (s) "Ethics Committee" means the committee referred to in rule 50; (t) "Form" means Forms specified in Appendix to these rules; (u) "Good Clinical Practices Guidelines" means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 5 of 248 (v) "intended use" means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling or in the document containing instructions for use 1 [or electronic instructions for use] of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority; (w) "invasive device" means a device which, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body; (x) "investigational medical device" in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause (zb), — (i) which does not have its predicate device as defined in clause (zm); or (ii) which is licensed under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule 36 and claims for new intended use or new population or new material or major design change, and is being assessed for safety or performance or effectiveness in a clinical investigation; (y) "licence" means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19, as the case may be; (z) "loan licence" means a licence issued for manufacturing a medical device by the State Licensing Authority or the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other licensee for manufacturing the same medical device as manufactured by the licensee at that site; (za) "long term use" means intended continuous use of a medical device for more than thirty days; (zb) "medical device" means, — (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 6 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i); (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii); (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;