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2026 China NMPA Bluebook is here:
The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices, and standardizes the classification materials. Newly Developed Medical Devices China NMPA does not have De Novo process like FDA’s. When a device is newly developed, NMPA mentioned in the document
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013 with two supplemental updates in 2017 and 2020 respectively. NMPA issued the “Draft Classification Catalog for IVD Reagents” on March 14, 2023 and finalized it on May 11, 2024. The new Catalog is the result of several years in effort to standardize the classification
The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57 Class III, 101 Class II and 23 Class I medical devices, and 10 combination products. It is the summary of classification requests submitted by overseas and domestic manufacturers. It also lists the contact numbers for
NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices. Complete List There have been 250 innovation devices approved since 2014 when the pathway was established. To get an English copy of innovation devices catalog, please email info@ChinaMedDevice.com. We have translated the “Innovation Device Approval
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting on the invaluable insights gained from our participation in the 13th CIMDR in 2023. CIMDR, China’s premier medical device regulatory forum, is a crucial event where NMPA, CMDE, and experts convene to release the latest regulatory
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 of NMPS down-classified devices. Full list of NMPA Down-classified Devices The following devices are down classified from Class III to Class II: There are also some devices revlassified from Class
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 of NMPS down-classified devices. Full list of NMPA Down-classified Devices The following devices are down classified from Class III to Class II: There are also some devices revlassified from Class
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
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: