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NMPA announced the Procedure of Dynamic Amendment of Medical Device Classification Catalogue (Draft) on November 13, 2020, providing a more risk-based and internationally recognized pathway for medical device classification. Feedbacks […]

NMPA granted Innovation Approval designation to eight medical devices on November 2, 2020. Complete List Product Name Manufacturer Pulsed Field Ablation System Medtronic, Inc. Bronchus RF Ablation Systems Suzhou Xinmai […]

Here are the latest NMPA regulatory and clinical affairs news articles in October 2020 for medical devices and IVDs pros. These updates are presented by China Med Device, LLC, your […]

The NMPA released the IMDRF (International Medical Device Regulators Forum) draft document of “PMCF (Post-Market Clinical Follow-Up) Studies” on October 22, 2020. The proposed document was passed by the IMDRF […]

Electronic signature, certificate and documents have gained popularity due to higher efficiency and availability overseas. Submission Material Electronic Signature NMPA issued a release called “Matters Related to the Trial Implementation […]

With an announcement on October 20, 2020, the NMPA reclassified 29 cancer biomarker-related reagents from Class III to Class II. Additionally, they modified its intended use. The draft version for […]

Thirty four industry standards for medical devices were issued by the NMPA on October 22, 2020. These were put in place to guide manufacturers for local type testing, clinical trials, […]

The NMPA issued a notice called “the Establishment of Medical Robotics Standardization Agency” on September 27. This is announcing the regulatory preparation for medical robotics. The agency is responsible for […]

NMPA granted priority review designation to CooperVision and Biomerieux on September 30, and gave its reason as below: soft hydrophilic contact lens, by CooperVision, on the ground that it is […]

CER (Clinical Evaluation Report) plays a vital role in the clinical pathway in China and predicate-comparison is the key element of CER. NMPA published Guideline on Technical Review on Predicate-Comparison […]