2. Applicability: The provisions of this Schedule shall be applicable to manufacturer ...

2. Applicability: The provisions of this Schedule shall be applicable to manufacturer ...

(g) "body orifice" means any natural opening in a human body including the external s ...

. The applicant shall provide and maintain suitable equipment having regard to the na ...

(i) for medical devices intended to emit ionizing radiation, information on radiation ...

(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of ...

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

This summary may include: (a) Where a recognized standard exists, a declaration/certi ...