APPLICATION FOR PERMISSION (1) An application in Form MD-22 shall be made to the Central Licensing Authority along with following data in accordance with tables, namely:— (i) Design analysis data as per Table 1. (ii) Bio-compatibility and Animal Performance Study as per Table 2. (iii) Information specified in Table 3 shall be submitted along with Investigator's Brochure as prescribed in Table 4, Clinical Investigational Plan as prescribed in Table 5, Case Report Form as prescribed in Table 6, Serious adverse event reported, if any, as prescribed in Table 7, Informed Consent Form as prescribed in Table 8, investigator's undertaking as prescribed in Table 9, of this Schedule and Ethics Committee approval, if available, as prescribed in Appendix VIII of Schedule Y of the Drugs and Cosmetics Rules, 1945. (iv) Regulatory status in other countries, including information in respect of restrictions imposed, if any, on use of investigational medical device in other countries, prescription based device, exclusion of certain age groups, warning about adverse device effect. Likewise, if the investigational medical device has been withdrawn in any country by the manufacturer or by regulatory authority, such information shall also be furnished along with reasons and its relevance, if any. This information must continue to be submitted by the sponsor to the Central Licensing Authority during the entire duration of marketing of the said medical device in the country; (v) Proposed 51[instructions for use or electronic instructions for use] or direction for use and labels shall be submitted as part of the application. The drafts of label shall comply with provisions of labeling rules specified in Medical Devices Rules, 2017: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 163 of 248 PROVIDED that after submission and approval by the Central Licensing Authority, no change in the 52[instructions for use or electronic instructions for use] shall be effected without such changes having been approved by the Central Licensing Authority; (vi) Report of clinical investigation should be in consonance with the format as prescribed in Table 10, such reports shall be certified by Principal Investigator. (2) For investigational medical device developed in India, clinical investigation is required to be carried out in India right from Pilot clinical investigation or first in human study and data generated should be submitted. (3) For investigational medical devices developed and studied in country other than India, Pilot Clinical Investigation or relevant clinical study data should be submitted along with the application. After submission of such data generated outside India to the Central Licensing Authority, permission may be granted to repeat pilot study or to conduct Pivotal Clinical Investigation. Pivotal Clinical Investigation is required to be conducted in India before permission to market the medical device in India except investigational medical device classified under class A, in exceptional cases, the Central Licensing Authority, may, for reasons to be recorded in writing, if consider it necessary, mandate conduct of clinical investigation, depending on the nature of the medical device. (4) The number of study subjects and sites to be involved in the conduct of clinical investigation shall depend on the nature and objective of the clinical investigation.