The Standards Office at the U.S. Commercial Service office to the European Union can provide guidance in obtaining regulatory approval for your product in the European Union.

U.S. Department of Commerce Medical Equipment Division provides U.S. companies in the sector with in-depth analysis on the industry, assists in export efforts, organizes high-profile trade missions, and gathers targeted sales leads. The division also tracks foreign regulatory policies, and assists with trade agreement negotiations.

U.S. companies can visit the U.S. Commercial Service Health Care team's e-Market Express to request the latest market research reports for the Health Care Technologies industry.

The U.S. Food and Drug Administration's Office of International Programs coordinates the Agency's interactions with foreign countries and regulatory counterparts, sets priorities for international activities, and provides overall policy guidance on international issues.

PhRMA, the Pharmaceutical Research and Manufacturers of America, based in Washington, D.C., represents the country’s leading research-based pharmaceutical and biotechnology companies.

ADVAMED, the Advanced Medical Technology Association,(formerly HIMA), based in Washington, D.C., is the largest medical technology association in the world, representing more than 1,100 innovators and manufacturers of medical devices, diagnostic products and medical information systems.

BIO, the Biotechnology Industry Organization, represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

The EU's Directorate General for Enterprise unit concerned with medical devices is concerned with the regulatory framework for market access, international trade relations and regulatory convergence, and the competitiveness of industry.

EU Scientific Committee on Medicinal Products and Medical Devices has the mandate to work on scientific and technical questions relating to Community legislation concerning medicaments for human and veterinary use and medical materials and equipment.

The MHRA, Medicines and Healthcare Products and Regulatory Agency, of the United Kingdom is an easy-to-use site of the agency that regulates medical devices and pharmaceutical products in the United Kingdom.

Links to web sites outside the U.S. Government or the use of trade, firm, or corporation names within U.S. Commercial Service web sites are for the convenience of the user. Such links and use do not constitute an express or implied official endorsement or approval by the United States Department of Commerce of any private sector web site, or of the products or services of specifically identified companies or entities.