ABSTRACT
No country regulates medical devices as consistently and thoroughly as the U.S. However, there is a trend toward regulation in other industrialized countries, especially in Europe. France requires registration and evaluation of medical devices for public hospitals. Germany passed a law in 1987 that requires the registration of all medical devices linked to approval by defined testing organizations. The U.K.’s Department of Health and Social Security is active in evaluating selected devices. And Italy also has a law, passed in 1986, that requires registration of all medical devices marketed in that country.
