| Class IIb and Class III(Registration by the Medical Devices and Supplies Committee) Art. 3(b)(3): the Committee must decide within a period not exceeding 45 working days from the date the Directorate receives the application with its documents complete Where the device is on the list requiring laboratory testing, the same 45 working days run instead from the date the Directorate receives the analysis result from the Drug Control Laboratory, so testing time sits outside the clock Art. 5(ب) routes these two classes to the Committee on the Annex 6 conditions Art. 5(ح): a device that fails the laboratory test twice in a row is refused, and the applicant must start a fresh application |