an undertaking from the manufacturer stating that the proposed device is a Class A no ...

FORM MD-1 [Refer sub-rule (5) of rule 13] APPLICATION FOR GRANT OF CERTIFICATE OF RE ...

(iii) an undertaking from the importer stating that the proposed device is Class A no ...

Central Drugs Standard Control Organisation-- Applicant Registration contact Accredi ...

Central Drugs Standard Control Organisation-- Applicant Registration contact Accredi ...

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

(vi) assess conformity to the product and process standards as per provisions of thes ...

1.2 Information regarding sterilization of the device (whether it is sterile or non-s ...