June 9, 2016

New Consultation Guidelines from Center of Medical Device Evaluation (CMDE)

The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medical Device Evaluation Consultation” for public comment on May 20, 2016, with comments solicitation period concluding on June 5, 2016. For future product registration – according to these draft guidelines – face-to-face consultation shall be limited to 3 sessions of …

New Consultation Guidelines from Center of Medical Device Evaluation (CMDE) Read More »

List of Clinical Trial Exempt Devices – Updated List by China Food and Drug Adminisration (CFDA)

The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second Listing” for public comment on May 20, 2016. This draft indicates CFDA’s increased governance on a wider range of medical devices and its assessment on the clinical trial requirements and expanded the list of clinical trial exempt devices. This …

List of Clinical Trial Exempt Devices – Updated List by China Food and Drug Adminisration (CFDA) Read More »