(2)The application made under sub-rule (1) shall be accompanied with the following information, namely:-(i)constitution of the medical device testing laboratory;(ii)premises showing location and area of the different sections;(iii)qualification, experience of technical staff employed for testing and the person in-charge of testing;(iv)list of equipment; and(v)valid accreditation certificate issued by the National Accreditation Body for Testing and Calibration Laboratories or any other similar body as may be notified by the Central Government.
