2023-09-14T05:11:45
(B) Such summary information may include:
(i) declaration or certificate of conformity to a recognised standard and summary of the data if no acceptance criteria are specified in the standard;
(ii) declaration or certificate of conformity to a published standard that has not been recognised, supported by a rationale for its use, and summary of the data if no acceptance criteria is specified in the standard;
(iii) declaration or certificate of conformity to a professional guideline, industry method, or in-house test method, supported by a rationale for its use, a description of the method used, and summary of the data in sufficient detail
to allow assessment of its adequacy;
(iv) a review of published literature regarding the device or substantially similar devices.
(C) In addition, where applicable to the device, the dossier should contain detailed information on:
(a) bio-compatibility studies data as per prescribed standards;
(b) medicinal substances incorporated into the device, including compatibility of the device with the medicinal substance;
(c) biological safety of devices incorporating animal or human cells, tissues or their derivatives;
(d) sterilisation;
(e) software verification and validation;
Have a question? Ask here!
Required fields are marked *