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, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 18 of 248 (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 NonSterile 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.