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2026 China NMPA Bluebook is here:
The NMPA granted innovative device status to 27 medical devices from July to September 2023: Cardiovascular Chemistry Dermatology Gastroenterology/Urology General hospital Neurology Oncology Ophthalmic Radiology Key Takeaways for Overseas Manufacturers
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023. Read the list
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 III, 80 Class II and
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 copy of innovation devices catalog,
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 manufacturers. Application Pathway Applicants log
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 innovative device approved by the
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. They attached “folder structure of
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 Boston Scientific, Edwards Lifesciences, Uptake
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, neurology, and radiology devices are
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 Class III, imported Class II
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 manufacturers to transfer the certificates
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 similar questions for your device