. The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority. (5) The testing and evaluation of medical devices shall be under active direction of a person whose qualification and experience is considered adequate and who shall be held responsible for reports of test or evaluation issued. (6) The applicant shall provide standards recognised under the provisions of the Act and these rules and such standards of reference as may be required in connection with the testing or evaluation of the devices for the testing of which approval has been applied for.