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(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinic...

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Obtaining a regulatory license often involves an application process, fees, background che...

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Condition of permission to import or manufacture medical device which does not have its pr...

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

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Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the in...

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

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Examined periodically, at least once a year. Records shall be maintained thereof. 6.2.2 Co...

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(ii) the applicant shall provide adequate space having regard to the nature and number of ...

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(ii) the applicant shall provide adequate space having regard to the nature and number of ...

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