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 licensed to manufacture such medical device for sale or for distribution. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 28 of 248 (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. 24. Inspection report After completion of inspection as referred to in rule 23, the inspection team shall forward a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central Licensing Authority, through online portal of the: Ministry of Health and Family Welfare in the Central Government and forward a copy of the same to the applicant.
Keywords
Subscribe for latest offers & updates
We hate spam too.