An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do no ...

Note: 1. All reports submitted as a part of the dossier should be signed and dated b ...

DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An ...

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

(b) If the device contains any of the followings, then descriptive information on th ...

Implantable medical devices and surgically invasive medical devices for long term use ...

This amendment is an important milestone as until now, only colistin was prohibited i ...

PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or ...