Certification bodies will be chosen by TPP and therefore only recognized bodies will likely be acceptable to satisfy the quality system requirement. The Regulations provide for the authorization to sell a non-licensed medical device at the request of a practising health care professional. An application for special access may be made by the health care professional to the TPP on condition that certain criteria are met. Generally, special access encompasses custom made devices or devices that may be required in an emergency or where conventional therapies have failed. The Regulations provide for a manufacturer to sell a non-licensed device for purposes of conducting investigational testing.
Authorization is contingent upon receiving institutional review board consent.
The Medical Devices Regulations came into effect July 1, 1998. All new Class II, III and IV devices that were not previously sold prior to that date and not duly notified with the Medical Devices Bureau may not be sold without a device license. All device licenses must be renewed by November 1, 1999. All establishment licenses must be renewed by January 1, 2000. The quality system requirement of the regulations comes into force July 1, 2001.