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Shanghai To Test Medical Device Registrant System


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The signing ceremony for strategic cooperation between Shanghai CFDA and Pudong District government. Shanghai will be the first pilot to experiment medical device registrant system.

Medical device registrant system means that the eligible medical device registration applicants are entitled to apply for a medical device registration certification independently, and then outsource the production to enterprises with qualification and production capacity to achieve the “unbundling” of medical device product registration and manufacture permission.

China Food and Drug Administration announced the exposure draft for relevant policy in May this year. The Draft required to sum up the pilot experience of drug launching authorization holders, combined with the modification of “The Decree of Drug Administration “, to implement the launching authorization holders system in pharmaceutical and medical device.

The attempt of pilot medical device registrant system will connect the international standard and will be helpful for motivating the enthusiasm of innovative medical talents, attract their focus on product development, while the production will be outsourced to professional enterprises. This kind of division of labor will speed up the marketing process of innovation products. It will bring benefits to more patients.

China Med Device, LLC.
Specializing in providing turn-key solutions for medtech and IVD companies’ entry into China. We bring you up-to-date information on CFDA regulation and medical industry trends in China and related regions. We offer business consulting, regulatory, funding and growth services for your product or services. If you have any feedback or inquiry, please email us at or visit us at

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