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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

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DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the audit ...

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(ii) Directors, executives and personnel responsible for carrying out evaluation and verif...

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Performance evaluation report from a laboratory designated under subrule (1) of rule 19. ...

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(b) a pivotal clinical investigation on an investigational medical device shall be made on...

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All relevant clinical and non-clinical safety data will cover only the period of the repor...

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Post Marketing Surveillance: (i) Subsequent to approval of an Investigational medical devi...

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Responsibilities of Sponsor: (i) The sponsor is responsible for implementing and maintaini...

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Description and specification, including variants and accessories of the in vitro diagnost...

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