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(iv) the m
2023-07-18T10:31:19
Accredited Consultants Pvt Ltd
(iv) the manufacturer shall self-certify that the product is conforming to the essential principles checklist

(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. (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;

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