(1) An application for grant of loan licence to manufacture for sale or distribution of Class A medical device referred under sub-rule (4) of rule 5, or Class B medical devices, as the case may be, shall be made to the State Licensing Authority in Form MD5 accompanied with fee as specified in the Second Schedule along with documents as specified in clause (i) of Part II or clause (ii) of Part II of the Fourth Schedule, as the case may be.
(2) An application for grant of loan licence to manufacture for sale or for distribution of Class C or Class D medical devices, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along with documents as specified in clause (ii) of Part II of the Fourth Schedule including details of the constitution of the firm, manufacturing premises plan or layout, full particulars of competent and regular technical staff, artwork of product literature, package insert or instruction for use, proposed device labels, shall be made to the Central Licensing Authority in Form MD6.
(3) Where any manufacturer intends to manufacture Class C or Class D medical device along with Class A or Class B medical device, an application for grant of loan licence shall be made as per sub-rule (3) of rule 15 to the Central Licensing Authority in Form MD6.
(4) The Central Licensing Authority may, wherever required, in case of Class A, Class B, Class C or Class D medical device, use the services of external agencies or bodies for matters relating to inspection or review of documents.
Conditions to be complied before grant of manufacturing licence or loan licence.
17. Before grant of licence or loan licence, the following conditions shall be complied with by the applicant,-
(i) Manufacturing activity of medical device shall be undertaken only under the direction and supervision of competent technical staff and who has,- 14
(a) degree in engineering (in appropriate branch) or in pharmacy or in science in appropriate subject and shall have experience of not less than two years; or
(b) diploma in engineering (in appropriate branch) or in pharmacy and shall have the experience of not less than four years in manufacturing of medical devices.
(ii) The testing shall be conducted under the direction and supervision of the competent technical staff having degree or diploma in engineering in appropriate branch or in pharmacy or in science in appropriate subject and shall have the experience of not less than two years in testing of medical devices.
(iii) The manufacturing site shall comply with the requirements of the Fifth Schedule.
Audit or inspection before grant of licence for manufacture.
18. Before grant of licence under this part,-
(i) in respect of Class A medical device referred under sub-rule (4) of rule 5or Class B medical devices, the establishment where manufacture of such device is proposed to be undertaken shall be audited by the Notified Body;
(ii) in respect of Class C or Class D medical devices, the establishment in which the manufacture is or proposed to be undertaken shall be inspected by the Medical Device Officer with or without an expert in the concerned field for adequacy and suitability;
Report by Medical Device Officer or Notified Body.