Documents to be submitted with the application for grant of licence to manufacture or ...

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

CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succinct doc ...

(ii) Documents to be submitted with the application for grant of licence to manufactu ...

Identification: The manufacturer shall identify the product by suitable means throug ...

(v) "intended use" means the use for which the medical device is intended according t ...

10.0 Analytical sensitivity: This section should include information about the study ...

If the medical device is intended to treat serious or lifethreatening diseases, occu ...