Summary

To compete successfully in the European Economic Community (EEC) and global markets, the U.S. medical device industry will have to adhere to international technical standards and the principles of total quality assurance. The current systems for premarketing regulation in the United States, Japan, and Canada are similar. All three countries are undergoing convergent changes to increase the safety and the effectiveness of devices, improve product quality and international competitiveness, and harmonize regulatory requirements. The main goals of the proposed EEC and U.S. regulatory systems, however, appear to be different. Whereas the proposed U.S. regulations stress device safety and effectiveness, the EEC regulatory system encourages the enhanced production and exchange of goods throughout the EEC. These differences could result in continued barriers to market access and failure to eliminate the current system of duplicate inspection and approvals for U.S. and foreign device manufacturers. Many U.S. device manufacturers are unaware of the nature, the scope, or the immediacy of the potential challenges to their industry from the global market or the EEC. Further, most U.S. device manufacturers are trying to improve product quality and boost their share of the domestic market rather than enhance their competitiveness in foreign markets.

GAO found that: (1) premarketing regulation and quality assurance for medical devices in the United States, Canada, and Japan vary somewhat, but function similarly; (2) the three countries are taking steps to improve medical devices and international competitiveness and harmonize their regulatory requirements; (3) the proposed EEC and U.S. regulatory systems have sufficient differences that could impede market access; (4) the EEC system does not approve new devices on the basis of compatibility with existing devices; (5) the EEC and U.S. systems differ on device classification; (6) the proposed EEC regulatory system emphasizes enhanced production and exchange of medical devices throughout EEC, whereas the proposed U.S. regulatory system emphasizes device safety and effectiveness; (7) 39 percent of U.S. medical device manufacturers are unaware of global market or EEC challenges to their industry; and (8) most U.S. manufacturers, except large and medium multinational manufacturers, are focusing on the domestic market, since they are not prepared to compete in the single market.