23. Inspection for grant of licence or loan licence for Class C or Class D medical device.
(1)Before grant of licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site shall be inspected within a period of sixty days from the date of application by a team comprising not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:Provided that no inspection of a medical device manufacturing site for grant of loan licence to manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to manufacture such medical device for sale or for distribution.(2)The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer and no inspection shall be carried out without prior approval of the controlling officer.
