December 10, 2020

Medical Device Clinical Trials in China Latest Regulatory Developments

Want to reduce your device’s clinical trial costs and accelerate its time to market in China? It’s possible when you use the latest China National Medical Products Administration (NMPA) regulatory […]
December 2, 2020

Learn how to cut years to months for initial clinical use with China Hainan RWD Pilot Program

Learn new Hainan RWD program to use NMPA unapproved devices in China directly from the authorities. Find out how to cut years to months for initial clinical use in real […]
November 24, 2020
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NMPA Device Classifications to be Modified Dynamically

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 […]
November 17, 2020

Eight Manufacturers, including Medtronic, Enter NMPA Innovation Pathway

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 […]
November 17, 2020
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Roundup – NMPA News October 2020

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 […]
November 8, 2020
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The NMPA Draft Document “Post-Market Clinical Follow-Up Studies” is Passed by the IMDRF

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 […]
November 5, 2020

Submission Material Signature and Registration Certificate Going Paperless

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 […]
November 5, 2020

The NMPA Down-Classified Certain Cancer Biomarker Reagents

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 […]
November 1, 2020
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The NMPA Released 34 Medical Device Standards in One Day

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, […]
November 1, 2020
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Medical Robotics Development Gains Momentum in China

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 […]
October 27, 2020

Two Imported Devices Obtained NMPA Priority Review Designation

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 […]
October 26, 2020

New CER Guideline Published for Intravascular Catheter

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 […]