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2004 March Report of the Auditor General of Canada
Exhibit 2.4—The Medical Devices Review Committee's report provided a vision for a comprehensive medical devices program
Key attributes
The Medical Devices Review Committee provided a vision for a comprehensive medical devices regulatory program with the following attributes:
- protects the patient and consumer,
- recognizes the responsibilities of industry, health care professionals and facilities, and the federal government,
- supports international regulatory co-operation,
- balances pre-market and post-market activities,
- is open, transparent, and cost effective, and
- incorporates the principles of risk and benefit management.
The Committee recommended that the program do the following:
Pre-market activities
- develop a requirement for a system to help ensure quality in the manufacturing of medical devices,
- develop a policy on managing the risks related to investigational testing,
- using a risk-based approach, evaluate a manufacturer's evidence of the safety and therapeutic effectiveness of a device before it is introduced on the market,
- issue a licence if the evaluation is favourable and renew the licence annually, and
- manage the evaluation process to prevent a backlog.
Post-market activities
- develop an active inspection program to help ensure industry is in compliance with the regulations and to publicly identify those that are not.
- develop a pro-active post-market surveillance system that provides sufficient adverse-events information to allow safety concerns to be identified. Suggestions include, but are not limited to, mandatory reporting of adverse events by manufacturers and health care professionals and ongoing surveillance processes, such as device registries.
- develop a communication plan and methods to disseminate information on health risks and benefits and safety concerns to health care professionals, and the public on a timely basis.
- amend the current legislation to provide additional enforcement options.
- promote education and training for health care professionals on devices.
Source: The Report of the Medical Devices Review Committee, 1992