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China Continues To Enhance Post Market Surveillance On Medical Devices

2021-12-17

Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June, 2021, China…

China NMPA Newsletter – November 2021

2021-12-15

Inspirative Medical – A BradyKnows Company November 2021 China NMPA Newsletter Official Publication of BradyKnows New E-filing Catalogue…

More Source Data Required For NMPA Clinical Trial Data Submission

2021-12-14

On Nov 25, 2021, NMPA published two guidelines on clinical data submission requirement for medical device and IVD…

How To Handle China Registration During The Transition Period From Old NMPA Requirements To New Requirements

2021-12-08

The Administrative Measures for Registration and Filing of Medical Devices (Order No. 47) and the Administrative Measures for…

NMPA AE And Recall Report In October 2021

2021-12-02

In October, 2021, NMPA published the AE and recall list reported by overseas manufacturers. Since China NMPA enhances…

NMPA AE And Recall Report In September 2021

2021-12-02

In September, 2021, NMPA published the AE and recall list reported by overseas manufacturers. Since China NMPA enhances…

New NMPA Review Guideline Of Animal Studies For Medical Device Registration

2021-11-27

On Sep 27, 2021, NMPA published a new Review Guideline of Animal Studies for Medical Device Registration: Part…

New E-filing Catalogue For Medical Device Registration Effective Since Jan 1, 2022

2021-11-17

According to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration…

China NMPA Newsletter – October 2021

2021-11-17

Inspirative Medical - A BradyKnows Company October 2021 China NMPA Newsletter Official Publication of BradyKnows Official NMPA Regulation…

New China GCP To Be Issued Soon

2021-11-10

As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the…

New Requirements For Medical Device And IVD Registration Application Dossiers

2021-11-03

More and more new guidelines are published according to the Regulations on Supervision and Administration of Medical devices…

Official NMPA Regulation Released: Self-Testing For Medical Device Registration In China

2021-10-27

Fundamental of Type Testing Type testing, also known as medical device registration testing, is a mandatory requirement by…
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