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an underta
2023-06-06T10:59:41
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an undertaking from the manufacturer stating that the proposed device is a Class A non-sterile and non-measuri

an undertaking from the manufacturer stating that the proposed device is a Class A non-sterile and non-measuring medical device, as per the First Schedule; (iv) the manufacturer shall self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices; (v) the manufacturer shall self-certify to comply with the standards specified in these rules; and (vi) an undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic. 19I. Registration number.― The registration number for a Class A nonsterile and non-measuring medical device shall be generated after furnishing of the information in accordance with rule 19H on the Online System for Medical Devices established for this purpose. 19J. Import of Class A non-sterile and non-measuring medical device.― (1) Any person who intends to import any Class A non-sterile and non-measuring medical device shall upload the information in subrule (2) relating to that medical device for registration on the Online System for Medical Devices. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 22 of 248 (2) The importer shall upload the following in the Online System for Medical Devices, namely:― (i) name and address of importer and the name and address of the manufacturing site; (ii) details of Class A non-sterile and non-measuring medical devices to be provided:Generic name Brand Name (if registered under the Trade Marks Act, 1999) Model No (if any) Intended use Material of construction Dimension (if applicable) Shelf life (if applicable) (1) (2) (3) (4) (5) (6) (7) (iii) an undertaking from the importer stating that the proposed device is Class A non-sterile and non-measuring medical device, as per the First Schedule; (iv) the importer shall self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices; (v) the importer shall self-certify to comply with the standards specified in these rules; (vi) self-attested copy of the overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority; and (vii) an undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic. 19K. Registration number for import.― The registration number for import of a class A non-sterile and non-measuring medical device shall be generated after furnishing of the information in accordance with rule Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 23 of 248 19J on the Online System for Medical Devices established for this purpose.

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