June 1, 2020

NMPA Guideline on Raw Material Changes for Non-active Devices: Eleven Examples

NMPA implemented the “Guideline on Raw Material Change Evaluation of Non-active Device” on May 19, 2020. The guideline has gone through modifications since the draft feedback was released on June […]
May 27, 2020

Periodic Risk Assessment Report: NMPA Further Specifies PMS Requirements

A Periodic Risk Assessment Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event […]
May 21, 2020

NMPA Approves the First Medical Device Through Real-World Data Program

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan since June 2019, was joined […]
May 11, 2020

NMPA News Roundup (April 2020)

Here’s April’s NMPA news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. For […]
May 8, 2020

NMPA to Down-Classify Certain Cancer Biomarker Reagents

NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. The impacted reagents include but not limited to the following: […]