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) -- In 2011, announced it will no longer exist. 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).
Select downloads
See Health Sciences specific service web pages for more articles and white papers on specific topics
- Visit UL Knowledge Services Thought Leadership pages to download the June 2010 version of "The 3rd Edition Update" and the 2010 article "A Review of Market Entry Requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance."
- 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)
- Download UL's Article 'Risk Management and Post-Market Surveillance: FDA Considerations'- Reproduced with the kind permission of Global Regulatory Press from the Journal of Medical Device Regulation, November 2010, 3-9 (www.globalregulatorypress.com) (registration required) (PDF)
