PROVIDED ALSO that, the results of clinical investigation may not be required ta be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device, and, — (a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behaviour and performance in Indicin population; (b) the applicant has given an undertaking in writing to conduct post marketing clinical investigation with the objective of safety and performance of such investigational medical device as per protocol approved by the Central Licensing Authority.