Christopher Chen

Christopher Chen

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NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading

CMDE Releases New Inquiry Rules on Medical Device Technical Review

On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”).  The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior … Continue Reading

CFDA Releases New Device Clinical Trial Exemption Catalogues for Comment

On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”).  Comments are due on June 20, 2016.  This is the second round of clinical trial exemption catalogues since the revisions to … Continue Reading