China proposes simpler medical-device re-registration rules

04/8/2013 | Clinica (subscription required)

The China Food and Drug Administration has proposed reducing the amount of information companies must submit to re-register medical products when no changes exist that would affect safety or efficacy. Certain applications would require no technical review, but applications involving significant changes that might affect product safety and efficacy would require a new product registration. The agency has also proposed a system to expedite approval of certain innovative medical devices, but it would apply only for devices made by companies licensed in China.

View Full Article in:

Clinica (subscription required)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Regional Director, Southeastern Region - State Affairs
America's Heatlh Insurance Plans (AHIP)
Washington, DC
Associate Manager, Regulatory Affairs
Stryker
Mahwah, NJ
Associate General Counsel
Patient-Centered Outcomes Research Institute
Washington, D.C , DC
Chief Executive Officer
CarePoint Health Plan
Jersey City, NJ
Senior Director, Research
America's Health Insurance Plans (AHIP)
Washington, DC