Medical device regulation for manufacturers.
Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.
McAllister
P
P
Department of Mechanical Engineering, Queen's University, Kingston, Ontario, Canada. mcallist@me.queensu.ca
Jeswiet
J
J
D002170:Canada; D003132:Commerce / Q000331:legislation & jurisprudence* / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D008004:Licensure / Q000331:legislation & jurisprudence / Q000592:standards; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards; D012015:Reference Standards; D014481:United States