DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICE ...

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

INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data inclu ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

DOCUMENTS TO BE FURNISHED ALONG WITH APPLICATION IN FORM MD-1 FOR GRANT OF CERTIFICA ...

THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FO ...

National Accreditation Body (1) The Central Government may, , by notification, design ...

The designated National Accreditation Body referred to in sub-rule (1) shall be resp ...