Breaking news from the signing ceremony for strategic cooperation between Shanghai CFDA and Pudong District government: Shanghai will be the first pilot city 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 and bring benefits to more patients.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------