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2026 China NMPA Bluebook is here:
The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7,
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
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 issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas
The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143
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
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
Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the
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
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
The NMPA Medical Device Standardization Administration released the second batch of results for medical device classification, excluding 86 products as medical devices. It also identifies
The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Classification Catalog 2020 Complete