Essential principles checklist: (i) The dossier should contain the following:— (a) th ...

5.0 Essential principles checklist: (i) The dossier should contain the following:— (a ...

The manufacturer shall ensure that non-conforming product is accepted by concession o ...

Medicinal substances: Where the medical device incorporates a medicinal substance, th ...

Particular requirement for active implantable medical devices and implantable medica ...

Customer complaint—Written, electronic or oral communication that alleges deficiencie ...

(b) the modification of a medical device and in vitro diagnostic medical devices; (c ...

(iv) ISO-10993, Biological Evaluation of Medical Devices, should be followed for cond ...