(2)The application made under sub-rule (1) shall also be accompanied with the following documents, namely:-(a)brief description of the medical device including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices;(b)list of equipment, instruments;(c)list of qualified personnel;(d)copy of manufacturing licence issued under these rules, if any;(e)approval letter authorizing to undertake research and development activities issued by any Government organization, if any.
