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.