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2026 China NMPA Bluebook is here:
“Regulation on the Supervision and Administration of Medical Devices”, published in March 2021, mandates that “if the design, raw materials, production process, scope of application,
The Guangdong government published the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. Policies China New
CMDE granted innovation and priority review status to four manufacturers in May, by which they can begin the fast-track application process. The complete list is
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for
NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-test and to submit the
NMPA issued the 2021 Medical Device Industry Standards Revisions Plan (draft) on May 26, in which 77 medical devices and IVDs are affected. The Standards
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in May 2021. Policies Major
China NMPA released eight draft clinical guidelines for urgent feedback to support the new overarching State Order 739, the “Regulation for Medical Device Administration and
The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021.
The NMPA granted innovation and priority review status to eight manufacturers in April, by which they can begin the fast-track application process. The complete list
The NMPA published Checkpoints for Medical Device Registrants and Fillers Conducting Adverse Event Monitoring on April 9, directing the manufacturers for quality management system inspection