McAllister P, Jeswiet J
Department of Mechanical Engineering, Queen's University, Kingston, Ontario, Canada.
Proc Inst Mech Eng H. 2003;217(6):459-67. doi: 10.1243/09544110360729090.
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.
由于向市场推出劣质或不安全产品可能造成的严重后果，医疗设备制造商面临的标准高于许多其他产品的制造商。在加拿大，医疗设备行业由加拿大卫生部根据《食品药品法》的《医疗器械法规》进行监管。《医疗器械法规》规定了医疗器械设计、开发和制造的要求，以确保投放市场的产品安全有效。加拿大卫生部还要求医疗器械制造商保存分销记录，以确保在产品召回时能够追踪到产品来源并成功联系消费者。从加拿大出口的医疗器械必须符合进口国的法规。加拿大的《医疗器械法规》以欧盟的《医疗器械指令》为基础，从而便于加拿大的医疗器械在欧洲市场获得批准。美国食品药品监督管理局对医疗器械的安全性和质量有单独且不同的要求。尽管已努力促进加拿大医疗器械在美国和欧盟的批准与贸易，但从多个监管机构获得批准可能会导致器械开发时间延长和成本增加。全球协调工作组是一个由日本、澳大利亚、欧洲、加拿大和美国医疗器械监管机构的成员组成的组织。该组织成立的目的是协调医疗器械法规，以促进国际贸易并规范所有国家可得的医疗器械质量。本文讨论了制造商在设计和制造医疗器械时必须满足的要求。
