TECHNICAL FILE  MAY INCLUDE THE FOLLOWING DOCUMENTS (AS APPROPRIATE)

1. Product description

2. Product classification

3. Life time of the product (shelf life if applicable)

4. Product specification / reference standard (refer note – 1)

5. Material specification

6. Product component and assembly drawings

7. Instruction of use / Label.

8. Process flow chart (brief description of manufacturing process)

9. Inspection procedure & sample test report.

10. Sterilization process validation (where appropriate)

11. EPSP Checklist

12. Undertaking to achieve ISO 13485 / IS 15579 Compliance within 12 months.

13. Copy of repeat orders from Indian Institutions/Overseas clients to demonstrate product acceptance ( waiver in case of new facility may be considered).

14. Layout of Plant

15. Environmental Controls (if applicable)