Category: NMPA (CFDA) Updates

NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” on December 13, 2019. Feedbacks need to be submitted

Only one out of five medical devices granted Innovative Device Status by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity

“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on

NMPA published unprecedented number of medical device regulations in November, including 21 final guidelines, 14 draft guidelines for feedback and 19 final industry standards. Generic

NMPA issued the “Medical Device Submission Document Requirements during the Supplement Phase” (Draft) on November 11, 2019. Feedback needs to be summited by November 30,

The NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited

Time: Tuesday, November 12, 2019 | 11:00 am – 12:00 pm ET Presented by China Med Device, LLC Register Here This webinar will cover different

NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological,

NMPA published the final version of Unique Device Identification (UDI) Rules on August 27, 2019, with implementation date of October 1, 2019. The Rules are

Leaders discussed the Real World Data (RWD) Pilot Program — a cost-effective and less time-consuming alternative to the traditional clinical trial — at a meeting