(ii) Directors, executives and personnel responsible for carrying out evaluation and ...

Suspension and cancellation of registration certificate of Notified Body (1) The Cen ...

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the a ...

CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies th ...

(viii) when any major non-compliance is observed during audit by the notified body wh ...

PRELIMINARY 1. Short title and commencement (1) These rules may be called the Medical ...

Discussion and overall conclusions The conclusions may include the following points:— ...

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