Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common
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,
NMPA published five guidelines for 3D printed devices from August to October 2019: Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue
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
China National Medical Products Administration regulates medical devices and pharmaceutical products across China. The NMPA was also known as China Food and Drug Administration in
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
In this article we will provide an update on Clinical Evaluation Report (CER) requirements in China by NMPA (CFDA). Furthermore, you will learn about areas
The Monthly 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
International Medical Device Regulators Forum (IMDRF) Committee Members meeting was held on September 17-19, in which China NMPA achieved two milestones. The commitments, on post-market-surveillance