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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 III, 80 Class II and 35 Class I medical devices, and 5 combination products. It is the summary of classification requests submitted by overseas and domestic manufacturers. It also lists the contact numbers for each
69 high-risk class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1, 2021. After that, UDI has been implemented with all Class III devices and IVDs, effective from June 1, 2022. Now the NMPA proposes many Class II devices to subject to UDI, with an announcement on November
The NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400 mandatory national and industry standards are included. Mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device
When learning about your product’s China NMPA regstration, the following questions are very important to know:
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. The classification and definition of the following devices are affected: NMPA Classification March 2022 Analytical Biochemical analysis instrument Western blotting instrument Biochemical immunoassay instrument Nucleic acid amplification analysis instrument Image scanning equipment Mass detection system Liquid Chromatography Instruments Orthopedic probe Orthopedic
With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from August 2018, is in the process of real-time dynamic adjustment. The latest changes were that certain neurosurgical and cardiac surgery devices are down classified from Class III to Class II in March 2022. China Med
Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from June 1, 2022. It was announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices” published in September 2021. 69 high-risk class III devices were included in the UDI application of First Group of Devices, which
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and aesthetic devices and modified intended use for some with an announcement on March 24, 2022. NMPA Neurosurgical Devices The following neurosurgical and cardiac surgery devices are down classified from Class III to Class II: catheter sterilization connector puncture needle catheter sheath dilator connection valve extension tube For the complete list of
The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example names for 31 medical devices. The impacted devices include but not limited to the following: Spinal Probe Bone marrow aspiration and biopsy system electric drill Mobile C-arm X-ray machine Patient monitor Oxygen inhaler RF hyperthermia
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 the Second Group of Devices” on September 17, 2021, with the effective date of June 1, 2022. 69 high-risk class III devices were included in the UDI application of First Group of Devices, which started
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs. It is an effort to implement risk-based clinical evaluations, and to make medical device clinical exemptions more consistent with internationally accepted standards. Ask us if your devices or IVDs are in the Catalog. Even
Frequently Asked Questions about China NMPA Registration for medical devices and IVDs: