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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 22 January 2015 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.
The GSP regulations establish minimum standards for device procurement, delivery acceptance, storage, sales, transportation and after-sales services. Distributors must implement quality management systems that cover all aspects of the distribution process, such as the quality and training of personnel, cold storage and cold-chain transportation, as well as computer information and recordkeeping.
(CFDA GSP Regulations)
Tags: RegLink, RegLink News, Good Supply Practices, GSP, Distribution
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