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Union of India - Section

Section 52 in The Medical Devices Rules, 2017

52. Permission to conduct clinical investigation.

- The Central Licensing Authority, after such further enquiry, if any, as considered necessary, may,-
(i)if satisfied, that the requirements of these rules have been complied with, grant permission to conduct clinical investigation for an investigational medical device in Form MD-23;
(ii)if not satisfied with the requirements as referred to in sub-clause (i), reject the application, for reasons to be recorded in writing, within a period of ninety days, from the date of application made under sub-rule (1) of rule 51.