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December 23, 2020

In Beijing, One Center Ethics Committee Review is Sufficient for Multicenter Study

A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. It will greatly accelerate […]
December 23, 2020

Another Special Region for Unapproved Device Usage in China—”Big Bay Area”

Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long as they are used in […]
December 9, 2020

NMPA Reviewers’ Evaluation Key Points on Peripheral Drug-Eluting PTA Balloon Catheter Revealed

The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review Report on the Peripheral Drug-Eluting […]
December 9, 2020

Guangdong Becomes Second Province to Import Unapproved Medical Device

“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong […]
December 4, 2020

Draft Guideline for Overseas Clinical Data Acceptance on IVD: Nine Types of Differences to Pay Attention

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020. Differences between […]
December 1, 2020

Implementation of Guideline on Real-World Data to Support NMPA (CFDA) Regulatory Approval is Here!

The NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on US Thanksgiving Day, November 26th, […]
December 1, 2020

NMPA Reviewer’s Opinion on Colorectal Cancer Detection Kit Revealed

NMPA granted Innovation Approval to the Colorectal Cancer Detection Kit, Combination Detection Kit for KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and FOBT (PCR fluorescent probe method – colloidal gold […]
November 24, 2020
nmpa standards october guidelines

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
nmpa news october 2020 header

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 […]
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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
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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 […]
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