(1)Any institute, organization or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time.(2)The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority.(3)Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority.(4)Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience.(5)With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule.(6)The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2.(7)The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or canceled, provided the registration certificate holder deposits a registration retention fee as specified in the Second Schedule every five years from the date of its issue.(8)If the registration certificate holder fails to pay the required registration certificate retention fee on or before due date as referred to in sub-rule (7), the registration certificate holder shall, in addition to the retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within ninety days, and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been canceled.(9)The Notified Body shall perform the functions as specified in Part II of the Third Schedule.(10)The Central Licensing Authority, may, in cases where the requirement specified for registration of Notified Body have not been complied with, reject the application and shall inform the applicant of the reasons for such rejection.(11)An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an appeal within forty five days from the date of receipt of such rejection before the Central Government, which may after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days.
