(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.
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