(1) Any accredited Notified Body shall be required to be registered with the Central Licensing Authority before carrying out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards and other requirements under these rules.
(2) An application for registration shall be made to the Central Licensing Authority in Form MD1 by the accredited Notified Body referred in sub-rule (1), accompanied with a fee specified in the Second Schedule along with the documents specified in Part I of the Third Schedule.
(3) The Central Licensing Authority, on being satisfied, shall register the entity as a Notified Body and issue a certificate in Form MD2 which shall be valid till it is suspended or cancelled or the Notified Body on its own decides not to work as a Notified Body and notifies the Central Licensing Authority of the decision.
(4) The Central Licensing Authority may, give a direction to the Notified Body to improve conditions in accordance with requirements of registration of the registration or suspend or cancel the registration of a Notified Body for reasons to be recorded in writing.
(5) The accredited Notified Body shall perform the functions as specified in Part II of the Third Schedule.
(6) The Central Licensing Authority may, in cases where the conditions for registration of Notified Body have not been complied with, reject the application and shall inform the applicant of the reasons for such rejection.
(7) An applicant who is aggrieved by the refusal of registration under sub-rule (5), may within thirty days from the date of receipt of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as considered necessary and after giving the said body an opportunity of being heard, pass such order in relation thereto as it thinks fit.
Medical Device Testing Officer or Medical Device