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REGULATORY GUIDANCE
FINAL GUIDANCE
Sr.No
Name
1
Guidance Document on Application for Grant of License in Form-28 for Manufacture of Medical Devices in India Under CLAA Scheme(01.01.2013)
2
Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Medical Devices in India (01.01.2013)
3
Guidance Document on Common Submission Format for Import License in Form-10 of Notified Medical Devices in India (01.01.2013)
4
Guidance Document on Common Submission Format for Import of Notified Diagnostic Kits in India (IVD's)
5
Guidance Document on Common Submission Format for Import of Non-Notified Diagnostic Kits in India (IVD's)
6
Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Diagnostic Kits in India (IVD's)
DRAFT GUIDANCE
REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS OF MEDICAL DEVICES IN INDIA
DRAFT SCHEDULE M IV (IVD's)