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Commerce Eyes China’s MoH To Revive Stalled Reforms Six Months Post-WTO

This article was originally published in The Gray Sheet

Executive Summary

The U.S. Deparment of Commerce (DoC) is charging an upcoming delegation to China with the task of determining why regulatory reforms in the country appear to have derailed in the past month

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International News In Brief

Device reuse: Several trade groups sign on Sept. 6 to manifesto calling for EU action to regulate all reprocessing of medical devices intended for single use by hospitals, reprocessors and original manufacturers. In addition to original drafters Eucomed and the Patients Association, new adopters include the European Medical Association, International Alliance of Patients' Organisations, Standing Committee of European Doctors of the EU and Standing Committee of Hospitals of the European Union (1"The Gray Sheet" April 29, 2002, p. 14). France, Italy, Germany, Portugal, Spain, Sweden and the UK have already introduced specific legislative measures against reuse, but the practice remains widespread on the continent, Eucomed notes. The 2final draft of the manifesto includes scientific evidence against reuse and legal implications of regulation...

International News In Brief

Device reuse: Several trade groups sign on Sept. 6 to manifesto calling for EU action to regulate all reprocessing of medical devices intended for single use by hospitals, reprocessors and original manufacturers. In addition to original drafters Eucomed and the Patients Association, new adopters include the European Medical Association, International Alliance of Patients' Organisations, Standing Committee of European Doctors of the EU and Standing Committee of Hospitals of the European Union (1"The Gray Sheet" April 29, 2002, p. 14). France, Italy, Germany, Portugal, Spain, Sweden and the UK have already introduced specific legislative measures against reuse, but the practice remains widespread on the continent, Eucomed notes. The 2final draft of the manifesto includes scientific evidence against reuse and legal implications of regulation...

QSRs Proposed As Alternatives To "Type Testing" In China and Korea

Chinese officials responsible for medical device regulation in China's State Drug Administration might participate in a proposed quality system regulation training program tentatively slated for late summer.

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