INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFACTURE OF MEDICAL DEVICES WHICH DOES NOT HAVE PREDICATE DEVICE (a) Data to be submitted along with the application (for medical devices other than new in vitro diagnostic):— 1. Design Analysis data including, (whichever applicable)— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (a) design input and design output documents; (b) mechanical and electrical tests; (c) reliability tests; (d) validation of software relating to the function of the device; (e) any performance tests; (f) in vitro tests. 2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale for selecting these tests. Summary report of the bio-compatibility study including the conclusion of the study. 3. Risk Management data. 4. Animal Performance study data. 5. Pilot or Pivotal Clinical Investigation data, including that carried out in other countries if any. 6. In case, if waiver from clinical investigation is claimed in accordance with the provisions of Medical Device Rules, 2017, the information or supporting data shall be submitted. 7. Regulatory status and restriction on use in other countries (if any) where marketed or approved. 47[8. Proposed instructions for use or electronic instructions for use and labels.] (b) Data to be submitted along with the application (for new in vitro diagnostic medical devices):— 1. Device data including, (whichever applicable)— (i) design input, design output documents, stability data; (ii) device specification including specificity, sensitivity, reproducibility and reputability; (iii) product validation and software validation relating to the function of the device (if any); Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (iv) performance evaluation report from a laboratory designated under sub-rule (1) of rule 19.