Additional resources

Regulators

• Health Canada
• FDA Center for Devices and Radiological Health (CDRH)
• Japan -- Ministry of Health, Labour, and Welfare
• Medicines and Healthcare products Regulatory Agency (UK)
• Therapeutic Goods Administration -- Australia

International harmonization groups

• Global Harmonization Task Force for Medical Instrumentation (GHTF)
 -- Composed of regulators and industry groups, GHTF was formed to respond to the need for international harmonization in the regulation of medical devices. Conformity assessment organizations are members by appointment by the national regulator.
• Asian Harmonization Working Party
 -- Its objectives are to forge a common direction for the harmonization of medical device regulation in Asia, encourage increased understanding on the benefits of harmonization and facilitate a linkage with the Global Harmonization Task Force (GHTF).

Available downloads

• Download your copy of "The 3rd Edition Update" -- Global Status of IEC 60601-1, 3rd Edition, August 2007 version (registration required) (PDF)
• Download Medical Device & Diagnostic Industry (MDDI), "Do We Need Medical Device Risk Management Certification?" by H. Rudolph, Nov. 2003 (PDF)
• Download MDDI, "Third Party 510(k) Reviews Gaining Popularity," by H. Rudolph, Oct. 2003 (PDF)