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2026 China NMPA Bluebook is here:
The NMPA Medical Device Standardization Administration issued the “Second Batch of Medical Device Classification Results for 2023” on July 13. The document identifies 71 Class
The NMPA granted innovation approvals to two devices on June 20, 2023. There have been 217 innovation devices approved since 2014. To get an English
The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas
On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its interventional coronary surgical control system accessories. It is the fifth imported
The NMPA issued a notice on April 19, adding error correction matters into their electronic Regulated Product Submission (eRPS) system, effective on April 20, 2023.
The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including
There have been 32 innovation approvals granted by the NMPA in 2022. Overseas manufacturer Medtronic, Ethicon and BioFire Diagnostics are on the list. Cardiovascular, gastro/urology,
The electronic registration certificate for medical devices will be fully implemented, starting on November 1, 2022. After October 2020, when the electronic certificates for domestic
The Guangdong government released the “Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)” to encourage medical device and IVD
The NMPA issued Q&A for 34 common issues aroused in medical device type testing and registration. Full List of NMPA common issues If you have
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
The NMPA granted Innovation Approvals to the following devices in July 2022: Cardiovascular Transcatheter prosthetic pulmonary valve system Implantable left ventricular assist system Radiology Gamma