Presentation: ISO 13485 Certification
Judy Findlay, M.A.Sc., P.Eng.
Director, Health Technology Research Group
Medical Devices for the U. S.
Presentation: Medical Devices for the U. S.
Carl Youngmann, PhD
Regulatory Affairs Certified
Medical Devices for the EU
Presentation: Medical Devices for the EU
Carl Youngmann, PhD
Regulatory Affairs Certified
Pacific Bridge Medical
Article: Medical Device Reimbursement in Japan
January 2007
Canadian Health Products and Food Branch (HPFB) and Australian Therapeutic Goods Administration (TGA) sign Memorandum of Understanding on Medical Devices
Officials of the governments of Australia and Canada have signed a Memorandum of Understanding (MoU) on the reciprocal recognition of quality management system (QMS) certificates for medical device manufacturers.
The signing of this MoU will enable Health Canada to recognize the QMS certifications issued by the TGA to Australian and New Zealand manufacturers exporting to Canada, and for TGA to recognize the QMS certifications issued by Health Canada recognized Registrars to Canadian medical device manufacturers exporting to Australia and New Zealand.
Health Canada Medical Devices Special Access Programme
The Special Access Program (SAP) allows doctors to gain access to medical devices that have not yet been approved for sale in Canada. Special Access is requested in emergency use cases or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.
All medical devices that have not been approved for use in Canada, in addition to certain custom-made devices, require special access authorization prior to being imported and/or sold in Canada.
Health Canada Cost Recovery Framework-Consultation
For more than fifty years, Health Canada has evaluated and monitored the safety, quality and efficacy of health products and food available to Canadians.
The world has changed rapidly over that period, with challenges posed by a range of social, economic, scientific and technological developments. In response, the Health Products and Food Branch (HPFB) recently launched a thorough review of its activities: the Blueprint for Renewal, which aims to modernize the Canadian regulatory system and strengthen its position as an internationally recognized regulatory leader. One of its key components is a revised Cost Recovery Framework.
Fees in the present Cost Recovery Framework have not changed since they were established in 1995. Meanwhile the complexity and volume of regulatory work has increased substantially, contributing to rising costs. The Health Products and Food Branch's budget is derived from appropriations as well as cost recovery revenues. HPFB has the authority to collect up to $41.2M through cost-recovery, although its actual revenues have averaged about $38M per year in the past several years. The cost recovery revenue level represents about 15% of HPFB's overall budget and approximately 25% of the budget of those program areas receiving cost recovery revenues. However, Canada recovers a much lower percentage of its costs from fees than do health regulators in comparable countries such as the United States, the U.K. and Australia.
The Auditor General of Canada (AG) in both 2004 and 2006, raised concerns about the ability of Health Canada to continue to fulfill regulatory requirements with the resource levels in place at the time, and recommended that Health Canada consider cost recovery as a mechanism to address this situation.
To maintain performance gains, address evolving scientific and technological realities and modernize the review process requires an infusion of resources. The proposed Cost Recovery Framework will, along with a review of the branch's core funding, serve to ensure stable funding for the regulatory process and contribute to our ultimate priority - the health and safety of Canadians.