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2026 China NMPA Bluebook is here:
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
NMPA (CFDA) issued the First Group of Unique Device Identification Devices (Draft) for feedback on September 17, and specified the medical devices going into UDI
NMPA (CFDA) published the “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)” on June 27. Discussing design control, change control, Basic Safety and
NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. Keep yourself updated with NMPA
After the U.S. announced the tariff plan of $300 billion Chinese exports, China released the newest tariff list on $75 billion of U.S. exported goods
NMPA (CFDA) published “Clinical Trial Exemptions Catalog for Medical Devices (Draft)” on August 1, 2019. It is an effort to implement risk-based clinical evaluation, and
NMPA published “Extension of Pilot Program for Market Authorization Holder (MAH) system” on August 1, introducing the MAH system for 18 provinces including the booming
Beijing NMPA office published Beijing In Vitro Diagnostics Inspection Plan on August 1, specifying the requirements in upcoming inspections, from today, August 16, to October