More Beneficial Policies For Imported Innovative Medical Devices
2021-07-16
On July 15, 2021, a total of three products entered into the innovative pathway. Among them, one is Control System of Coronary Intervention from Corindus Inc., the other two are Urothelial Cancer Chromosome Abnormality Detection Kit and Heart Cryoablation System from two Chinese companies.
In addition, the Human PDGFRA Gene D842V Mutation Detection Kit (PCR fluorescence probe method), a domestic product, entered into the priority pathway as it was identified as a clinical urgent need, and no predicate has been approved for registration in China before. In addition to the beneficial policies in Hainan, both innovative pathway and priority pathway are fast tracks to expedite the registration and marketing of products.
It is not hard to find out that China is encouraging the registration of innovative medical devices now. Based on previous policies, country of origin approval was mandatory for imported medical devices. However, the latest Medical Device Supervision and Administration Regulations (2021 version) that came into effect on June 1st, 2021 stipulates that country of origin approval will no longer be a mandatory requirement for some of the imported innovative medical devices. This will encourage the application of the state-of-the-art technology to be introduced into China, which is also a golden opportunity for overseas manufacturers.
See our webinar–New Exemptions in Order 739 for more details:
