Draft Guidance

1. Guidance Document on Common Submission Format for Import Licence in Form 10 of Medical Devices in India

2. Guidance Document on Common Submission Format for Registration of Medical Devices in India

 3. Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme  

4, Requirements for Conducting Clinical Trial(s) of Medical Devices in India

5.  DRAFT CHECK LIST OF DOCUMENTS TO BE SUBMITTED FOR THE GRANT OF         FORM-10  LICENSES FOR  THE IMPORT OF NON –CRITICAL DIAGNOSTIC KITS/REAGENTS

6. Draft Schedule M IV  

7. Import Licence of  Non-Notified diagnostic  kits in India

8. Import Licence of Notified diagnostics kits

9. Registration of Notified Diagnostics Kits