(1) The Central Government may, by notification, establish or designate Central medical devices testing centre or laboratory or any other centre for,-
(a) testing and evaluation of medical devices;
(b) functioning as an appellate centre or laboratory;
(c) carrying out any other function as may be specifically assigned.
(2) The State Government may, by notification, establish State medical devices testing centre or laboratory for test or evaluation of medical devices and carrying out any other function as may be specifically assigned.
(3) Medical Device Testing Centre involved for test or evaluation of medical devices other than in vitro diagnostic medical devices on behalf of the manufacturer shall be accredited by the National Accreditation Body designated under rule 10.
(4) Medical Device Testing Centre involved for test or evaluation, of in vitro diagnostic medical devices specified time to time by the Central Government, on behalf of the manufacturer shall be accredited by National Accreditation Board for Testing and Calibration Laboratories or any other similar body as may be notified by the Central Government for such accreditation.
Part IV Manufacture of Medical Devices for sale or for distribution Application for manufacture for sale and distribution of medical device.