Conditions for permission After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely:— (i) clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee; (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinica ...

Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development. 6. Investigational medical device and methods 6.1 Investi ...

Design and development review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements— (a) to evaluate the ability of the results of design and development to meet requirements; and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with th ...