Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The NMPA issued the “Technical Review Points for Tumor Gene Variation Detection Reagents (Trial)” on June 15, 2026. This guidance covers NGS‑based IVD reagents for
The NMPA granted innovation approval to B.Braun Avitum’s CRRT hemofilter and issued a review report. The published review reports like this one serve as important
The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. NMPA organized a remote inspection of KARL
The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026. The thermal vapor therapy
3. Clinical Evaluation Strategies Clinical studies are the decisive point for the registration of innovative Class III devices. The NMPA reports provide clear examples of
Patent Background One of the patents for medium-term corneal preservation solution (Application No. CN200410091007.5, filed on November 15, 2004) was submitted by Shandong Eye Institute.
On June 27, 2025 NMPA approved the corneal preservation solution, developed by the team at Shandong First Medical University Affiliated Ophthalmic Hospital (Shandong Eye Hospital)
NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline
The NMPA granted innovation approvals to Inari Medical’s FlowTriever Retrieval/ Aspiration System and issued a review report. The published review reports like this one serve
In recent decades, the widespread application of dental implants in the field of dentistry has significantly improved the quality of life for countless edentulous patients.
The NMPA granted innovation approvals to Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and issued a review report. The published review reports like this one serve
II. Regulatory Landscape and Global Market Integration NMPA The NMPA classifies punctal plugs as Class III medical devices under the code 16-07-05, denoting the highest