ABSTRACT
The Medical Devices Regulations are administrated by theTherapeutic Products Programme (TPP), which recognizes and strongly endorses the importance of harmonization as a key factor of these Medical Devices Regulations. Harmonization of requirements to the greatest extent possible with the European Union and United States, would facilitate mutual recognition agreements (MRAs) with both these jurisdictions, which in turn would lead to elimination of duplication of third party audits and significant cost savings to industry and regulators. Canada has signed an MRA with the ED, and the Afedical Device Regulations are similar with the ED Medical Device Directive (MOD). The groundwork is also being laid to facilitate similar agreement with the FDA. In the broader international scheme Canada is participating in the Global Harmonization Task Force (GHTF).
