REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE FOR CONDUCTING CLINICAL INVESTIGATION 1. 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 Likewise, if the investigational medical device has been withdrawn in any country by the manufacturer or by regulatory authority, such information shall also be furnished along with reasons and its relevance, if any.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.