CDRH’s commitment to assuring patients and providers have timely and continued access to safe, effective, and high-quality medical devices involves engaging with international regulatory agencies to promote alignment in regulations.
Safety standards and regulations for medical devices vary from country to country. By engaging with regulatory authorities from other countries, CDRH works to implement policies and programs that align these standards and regulations.
CDRH meets with manufacturers and regulatory authorities such as Health Canada (HC), Japan’s Ministry of Health, Labour, and Welfare (MHLW), and the Asia-Pacific Economic Cooperation (APEC) to exchange regulatory information. CDRH exchanges information through web-based training, scientific and policy discussions, and confidentiality commitments.
CDRH’s international efforts are an important step in reducing barriers to medical devices with the potential for important public health impact reaching U.S. patients.