(f) Undertaking signed stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule. (g) Documents as specified in the clause (b) of paragraph (i) of this Part. 43[(h) In case of in-vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant: PROVIDED that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority.]