Four Supporting Regulations Have Been Released in One Day

China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, Order 739.  Four supporting regulations have been released today for public feedback with due date on April 25th, 2021.  They have been working on these for a while already. You can send feedback online or email us. More detailed regulations are expected to be released from NMPA in addition to the four below.  A major training expected in Beijing in mid-April with key personnel directly from NMPA.

If you have or plan to have devices and IVDs registered or distributed in China, this is a great opportunity for you to give feedback.  I have provided the Chinese link below.

“Measures for the Supervision and Administration of Medical Device Sales Operation (Draft for Public Feedback)”

“Measures for the Supervision and Administration of Medical Device Production (Draft for Public Feedback)”

“Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Draft for Public Feedback)”

“Measures for the Administration of Medical Device Registration (Draft for Public Feedback)”