Anna Zhao

Anna Zhao

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CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … Continue Reading

CFDA Proposes Priority Review Pathway for Certain “Breakthrough” Medical Devices

The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules).  This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which was released in … Continue Reading
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