22. Requirements for grant of manufacturing licence or loan licence.
- While making application for grant of licence or loan licence under rule 20 or rule 21, the applicant shall meet the following requirements, namely:-(i)the manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule;(ii)appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken and such staff shall possess the following educational qualification and experience,-(a)degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from a recognized University and shall have experience of not less than two years in manufacturing or testing of medical devices; or(b)diploma in engineering (in relevant branch) or in pharmacy from a recognized institute and shall have the experience of not less than four years in manufacturing or testing of medical devices;(iii)appoint competent technical staff with degree or diploma in engineering (in relevant branch) or in pharmacy or in science in relevant subject and having experience of not less than two years in testing of medical devices under whose direction and supervision, the testing activity of a medical device shall be undertaken.
