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Search Results for: Medical Device Classification Catalog – Page 2

NMPA Officials on Aesthetic Active Devices: A Strategic Overview for Global Manufacturers

In recent years, active devices based on laser, ultrasound, and radiofrequency technologies have gained significant popularity in the field of aesthetic medicine due to their remarkable effectiveness and diverse applications. These devices are widely used across medical institutions, aesthetic clinics, and even in home settings. However, the rapid expansion of this market has been accompanied by a rise in adverse

268 IVD Classifications Released by NMPA

The NMPA Medical Device Standardization Administration issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268 IVD reagents. It is the summary of classification requests submitted by overseas and domestic manufacturers. It also lists the contact numbers for each NMPA review department. If you want a face-to-face consultation, just as FDA’s

NMPA’s New Device Classification Rules Take Effect September 1, 2024

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. NMPA will implement these new rules from September 1, 2024. Newly Developed Medical Devices China NMPA does not have De Novo process like FDA’s. When

List of Medical Device Mandatory Standards Released

NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024, 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

NMPA Adjusts the Device Classification Procedure

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

New IVDs Classification Catalog Finalized by NMPA, Effective Jan 1, 2025

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

Latest NMPA Device Classifications Released

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

Two Imported Devices Gain Innovation Approval in December

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

Navigating the Future: Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and Anticipating the 14th CIMDR in 2024

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

NMPA Down-Classified Five Class III Medical Devices

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

NMPA Down-Classified Five Class III Medical Devices

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

Latest NMPA Device Classifications Released

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

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