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Search Results for: Medical Device Classification Catalog – Page 3

NMPA Re-Classified Certain Analytical, Ortho, Dental Devices

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

How are Medical Devices Classified? Here is the Summary of our Catalogs

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

All Class III Devices, IVDs Subject to UDI Starting June 1, 2022

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

NMPA Down-Classified Certain Neuro, Cardiac Surgery Devices

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

NMPA to Re-Classify 31 Medical Devices

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

All Class III Devices & IVDs Subject to UDI Starting June 1, 2022

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

More Class II & III Medical Devices and IVDs Exempted from Clinical Trials

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

NMPA Finalizes Artificial Intelligence (AI) Software Classification Guideline

NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and regulatory submission. It is the finalized version of the draft released on May 3, 2021. Please click HERE for our technical review on AI-aided Software Guideline. The article was published on BioWorld, a Hong Kong-based

NMPA Guideline Proposes All Class III Devices Subject to UDI

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 (draft for feedback)” on May 31, 2021. The proposed effective date of January 1, 2022. Feedbacks need to be submitted by June 15, 2021. 69 high-risk class III device were

NMPA Annual Report for Medical Device Registration; Dental and Imaging Equipment Imported Most

The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number. Despite the impact of the pandemic, the total number of acceptance increased by 15.6% compared with 2019.

16 Class III Devices Exempted from Clinical Trial

The NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluations, and to make medical device clinical exemptions more consistent with internationally accepted standards, the NMPA stated in the notice. Ask us if your devices or IVDs are in the Catalog. Even

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