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.