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2026 China NMPA Bluebook is here:
On March 2, 2022, Human Genetic Resources Administration of China (HGRAC) released the “Frequently Asked Questions on Human Genetic Resources Management”. On March 22, 2022,
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on an iliac vein stent system. Both technical and clinical
The NMPA published 33 review reports from January to April 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold
The NMPA issued the “Clinical Pathway Recommendations for Certain Active and Passive Implantable Devices” on April 6, 2022. The document suggests manufacturers how to choose
The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022. The “China
Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological
The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega-cities of
“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical
The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly