Medical Devices Regulations

37 If the terms and conditions of a medical device licence for an in vitro diagnostic device require that tests be performed to ensure that the device continues to meet the applicable requirements set out in sections 10 to 20, no person shall sell a device from a lot of the in vitro diagnostic device unless

• (a) the results and protocols of the tests performed on devices in the lot have been provided to the Minister; and

• (b) the Minister determines, on the basis of the results and protocols provided that the devices in the lot continue to meet the applicable requirements set out in sections 10 to 20.