THE MEDICAL DEVICES RULES, 2017

(As amended vide GSR 777(E) dt. 14-10-2022(w.e.f. 14-10-2022) Whereas the draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government, after consultation with the Drugs Technical Advisory Board, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Gazette containing the said notification were made available to the public; And whereas, copies of the Gazette containing the said notification were made available to the public on the 17th October, 2016; And whereas, all objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules, namely: CHAPTER I PRELIMINARY 1. 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 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; (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; (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; (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 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; Explanation : For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro diagnostic medical device; (zc) "medical device grouping" means a set of devices having same or similar intended uses or commonality of technology allowing them to be classified in a group not reflecting specific characteristics; (zd) "Medical Device Officer" means an officer appointed or designated by the Central Government or the State Government, as the case may be, under sub-rule (2) of rule 18; (ze) "medical devices testing laboratory" means any institute, organisation registered under sub-rule (3) of rule 83 for carrying out testing or evaluation of any medical device on behalf of a licensee for manufacture for sale; (zf) "Medical Device Testing Officer" means an officer appointed or designated by the Central Government under sub-rule (1) of rule 18; (zg) "near-patient testing" means any investigation carried out in a clinical setting or at the patient's home for which the result is available without reference to a laboratory and rapidly enough to affect immediate patient management; (zh) "new in vitro diagnostic medical device" means any medical device as referred to in sub-clause (A) of clause (zb) used for in vitro diagnosis that has not been approved for manufacture for sale or for import by the Central Licensing Authority and is being tested to establish its performance for relevant analyte or other parameter related thereto including details of technology and procedure required; (zi) "notified" means notified in the Official Gazette by the Central Government, (zj) "Notified Body" means a body corporate or other legal entity, registered under rule 13 as a body competent to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards; (zk) "performance evaluation" in relation to in vitro diagnostic medical device means any systematic investigation by which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for its intended use; (zl) "Post Marketing Surveillance" means systematic process to collect and analyse information gained from medical device that have been placed in the market; (zm) "predicate device" means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India; (zn) "Quality Management System" means requirements for manufacturing of medical devices as specified in the Fifth Schedule; (zo) "reagent" means a chemical, biological or immunological component, solution or preparation intended by the manufacturer to be used as in vitro diagnostic medical device; (zp) "recall" means any action taken by its manufacturer or authorised agent or supplier to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied, because the medical device,— (a) is hazardous to health; or (b) fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or (c) does not meet the requirements of the Act and these rules; (zq) "serious adverse event" means an untoward medical occurrence that leads to,— (i) a death; or (ii) a serious deterioration in the health of the subject that either— (A) resulted in a life-threatening illness or injury; or (B) resulted in a permanent impairment of a body structure or a body function; or (C) required in-patient hospitalisation or prolongation of existing hospitalization; or (D) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function; or (iii) foetal distress, foetal death or a congenital abnormality or birth defect; (zr) "short term use" means intended continuous use of a medical device for not less than sixty minutes but not more than thirty days; (zs) "specimen receptacle" means a device, whether vacuum type or not, specifically intended by its manufacturer for the primary containment of specimens derived from human or animal body; (zt) "sponsor" includes a person, an investigator, a company or an institution or an organisation responsible for the initiation and management of a clinical investigation or clinical performance evaluation in India; (zu) "State Licensing Authority" means the authority designated by the State Government under sub-rule (2) of rule 8; (zv) "transient use" means a device intended for continuous use for less than sixty minutes; (zw) "transmissible agent", for the purpose of classification of in vitro diagnostic medical device, means an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease; (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them m the Act and the Drugs and Cosmetics Rules, 1945. CHAPTER II REGULATION OF MEDICAL DEVICE 4. Classification of medical devices (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:— (i) low risk - Class A; (ii) low moderate risk - Class B; (iii) moderate high risk - Class C; (iv) high risk - Class D. (2) In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:— (i) low risk - Class A; (ii) low moderate risk - Class B; (iii) moderate high risk - Class C; (iv) high risk - Class D. (3) The Central Licensing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule. (4) Based on the classification referred to in sub-rule (3), class-wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation: PROVIDED that the Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. 5. Medical device grouping Any person who intends to apply for grant of licence in respect of medical devices for,— (i) import; (ii) manufacture for sale or for distribution; and (iii) sale, stock, exhibit or offer for sale, may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices. 6. Essential principles for manufacturing medical devices Medical device manufacturer shall 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. 7. Product standards for medical device (1) The medical device shall 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. (2) Where no relevant standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards. (3) In case of the standards which have not been specified under sub- rule (1) and sub-rule (2), the device shall conform to the validated manufacturer's standards. CHAPTER III AUTHORITIES, OFFICERS AND BODIES 8. Licensing Authorities (1) The Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to,— (i) import of all Classes of medical devices; (ii) manufacture of Class C and Class D medical devices; (iii) clinical investigation and approval of investigational medical devices; (iv) clinical performance evaluation and approval of new in vitro diagnostic medical devices; and (v) co-ordination with the State Licensing Authorities. (2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to,— (i) manufacture for sale or distribution of Class A or Class B medical devices; (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes. 9. Delegation of powers of Licensing Authorities (1) The Central Licensing Authority, may with the prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other office:: of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller. (2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central Licensing Authority under its name and seal. (3) The State Licensing Authority, may, with the prior approval of the State Government, by an order in writing, delegate all or any of its powers to any officer under its control. (4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State Licensing Authority under its name and seal. 10. Controlling officer Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to exercise powers and functions under these rules for areas and purposes specified, by an order, of the Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned. 11. National Accreditation Body (1) The Central Government may,, by notification, designate such institute, firm or a Government aided or Government organisation, which fulfills the criteria specified from time to time by the Government, as the National Accreditation Body: PROVIDED that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect. (2) The National Accreditation Body shall have the required number of competent persons for proper performance of its functions. (3) The designated National Accreditation Body referred to in sub-rule (1) shall be responsible for carrying out the assessment of such entities who may apply for accreditation to become a Notified Body for the purpose of these rules. (4) The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the entity which applied for accreditation, issue a certificate to such entity in respect of specified categories of standards for which such entity has been assessed and found qualified: PROVIDED that where the entity has been found not possessing the requisite qualification and other requirements, the National Accreditation Body, shall reject the application. (5) The National Accreditation Body shall not act as a Notified Body. 12. Functions of National Accreditation Body The National Accreditation Body shall,— (a) lay down the conformity assessment activities for accreditation of Notified Bodies and lay down standards for such accreditation; (b) prepare norms and procedures for accreditation of Notified Body; (c) audit a Notified Body periodically for assessing conformance with these rules and the norms laid down by it. 13. Notified body (1) Any institute, organisation or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time. (2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A 2 [(other than non-sterile and non-measuring)] and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority. (3) Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A 3 [(other than non-sterile and non-measuring)] or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority. (4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience. (5) With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule. (6) The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2. (7) The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled, provided the registration certificate holder deposits a registration retention fee as specified in the Second Schedule every five years from the date of its issue. (8) If the registration certificate holder fails to pay the required registration certificate retention fee on or before due date as referred to in sub-rule (7), the registration certificate holder shall, in addition to the retention fee, be liable to pay a late fee calculated at the rate of two per cent, of the registration certificate retention fee for every month or part thereof within ninety days, and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled. (9) The Notified Body shall perform the functions as specified in Part II of the Third Schedule. (10) The Central Licensing Authority, may, in cases where the requirement specified for registration of Notified Body have not been complied with, reject the application and shall inform the applicant of the reasons for such rejection. (11) An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an appeal within forty- five days from the date of receipt of such rejection before the Central Government, which may after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days. 14. Duties of Notified Body A registered Notified Body, referred to in rule 13, shall carry out its duties and functions, in respect of Class A 4[ (other than non-sterile and non- measuring)] or Class B medical devices as specified in Part II of the Third Schedule. 15. Procedure to be adopted by Notified Body A registered Notified Body shall carry out its duties and functions either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of the Third Schedule. 16. Fees to be charged by Notified Body A registered Notified Body may charge fee from the applicant for the services rendered by it as may be determined by the Central Government. 17. Suspension and cancellation of registration certificate of Notified Body (1) The Central Licensing Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the Central Licensing Authority thinks fit, if in its opinion, the Notified Body has failed to comply with any provision of these rules. (2) A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may, within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm, reverse or modify such order. (3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been cancelled with effect from the expiry of the date of the validity of its accreditation by a National Accreditation Body. 18. Medical Device Testing Officer and Medical Device Officer (1) The Central Government may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing Officer. (2) The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer. (3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2) respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have been appointed as the Government Analyst and the Inspector, respectively. 19. Central medical device testing laboratory (1) The Central Government may, by notification, establish Central medical devices testing laboratory for the purpose of,— (a) testing and evaluation of medical devices; or (b) functioning as an appellate laboratory; or (c) to carry out any other function as may be specifically assigned to it. (2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as central medical devices testing laboratory for the purposes specified in sub-rule (1): PROVIDED that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories: 5 6[ CHAPTER IIIA REGISTRATION OF CERTAIN MEDICAL DEVICES 19A. (1) This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Annexure of Eighth Schedule of these rules. (2) The Medical devices referred in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose: PROVIDED that registration under this Chapter shall be on voluntary basis for a period of eighteen months from the commencement of this Chapter there after it shall be mandatory. 19B. (1) The manufacturer of a medical device shall upload the information specified in sub-rule (2) relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose. (2) The manufacturer shall upload,— (i) name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device, (ii) Details of medical device Generic Name Model No. Intended Use Class of Medical device Material of Constructi on Dimension (if any) Shelf Life Sterile or Non- Sterile Brand Name (if registered under the Trade Marks Act, 1999) (iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device: 7 [PROVIDED that in case the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes. Explanation : For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice.] (iv) undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic. 19C. After furnishing of the above information on the "Online System for Medical Devices" established by Central Drugs Standard Control Organisation for this purpose by the applicant's, registration number will be generated. Manufacturer 8[ may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders] on the label of the medical device. 19D. (1) Any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose. (2) The importer shall upload,— (i) name of the company or firm or any other entity importing the medical device and specification and standards of that medical device, (ii) Details of medical device Generic Name Model No. Intended Use Class of Medical device Material of Construction Dimension (if any) Shelf Life Sterile or Non- Sterile Brand Name (if registered under the Trade Marks Act, 1999) (iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device: 9 [PROVIDED that in case the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes. Explanation : For the remova

[GSR 78(E), dt. 31-1-2017, w.e.f. 1-1-2018] [PROVIDED FURTHER that the testing laboratories of State Governments and Central Government shall be exempted from the requirement of the accreditation by the National Accreditation Board for Texting and Calibration Laboratories for a period of two years from the date of coming into force of the Medical Devices (Fifth Amendment) Rules, 2019.] [(1A) Any person not holding licence under sub-rule (1) and intends to sell medical devices exclusively as referred to in clause (zb) of rule 3, shall obtain registration certificate as provided in these rules.] [Refer rule 4] [87A(3), 87C(1) and] 91] [Refer rules 13(5), 13(9), 14,15, 20(4), 20(6)] [Refer rules 20(2), 21(2), 34(2), 34(4), 63(1) and 64(1)] [8. Proposed instructions for use or electronic instructions for use and labels.] [5. Proposed instructions for use or electronic instructions for use and labels.] [Refer rules 20(3), 20(5), 20(8), 22(i)] [Refer sub-paragraph 6.4(b)] [Refer rules 26(iii), 26(iv), 38(v) and 38(vii)] [Refer rules 51(1), 51(2), 53(H), 53(v), 59(3)] [11. Proposed instructions for use or electronic instructions for use and label.] [Refer rule 90] [Refer sub-rule (5) of rule 13] [Refer sub-rule (6) of rule 13] [Refer sub-rule (2) of rule 20] [Refer sub-rule (2) of rule 20] [Refer sub-rule (4) of rule 20 and sub-rule (6) of rule 20] [Refer sub-rule (4) of rule 20 and sub-rule (6) of rule 20] [Refer sub-rule (1) of rule 21 and sub-rule (2) of rule 21] [Refer sub-rule (1) of rule 21 and sub-rule (2) of rule 21] [Refer sub-rule (1) of rule 25] [Refer sub-rule (1) of rule 25] [Refer clause (vii) of rule 26] [Refer sub-rule (1) of rule 31] [Refer sub-rule (3) of rule 31] [Refer sub-rule (1) of rule 34] [Refer sub-rule (1) of rule 36] [Refer sub-rule (2) of rule 40] [Refer sub-rule (1) of rule 41] [Refer sub-rule (1) of rule 42] [Refer sub-rule (2) of rule 42] [Refer sub-rule (2) of rule 43] [Refer sub-rule (3) of rule 43] [Refer sub-rule (1) of rule 51] [Refer clause (i) of rule 52] [Refer sub-rule (2) of rule 59] [Refer sub-rule (5) of rule 59] [Refer sub-rule (1) of rule 63] [Refer sub-rule (2) of rule 63] [Refer sub-rule (1) of rule 64] [Refer sub-rule (2) of rule 64] [Refer sub-rule (1) of rule 67] [Refer sub-rule (4) of rule 67] [Refer sub-rule (2) of rule 68] [Refer rule 69] [Refer rule 72] [Refer rule 74] [Refer rule 76] [Refer rule 77] [Refer sub-rule (1) of rule 78] [Refer sub-rule (1) of rule 81] [Refer sub-rule (3) of rule 83] [See sub-rule (2) of rule 87A] [See sub-rule (8) of rule 87B]