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February 26, 2021

Imaging Ultrasonic Diagnostic Equipment Clinical Guideline Issued by NMPA

NMPA published “Clinical Evaluation Guideline on Medical Imaging Ultrasonic Diagnostic Equipment with the Same Variety” on January 19, 2021. The 27-page document provides manufacturers detailed pathway for clinical evaluation, which […]
February 26, 2021

Imported Products Must Provide COVID-19 Nucleic Acid Test Report

On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products. Mentioned in the Guideline, “the […]
February 26, 2021

More Information Released on the Pilot Trial in Greater Bay Area

Before July 21, 2021 the devices and drugs from Hongkong and Macao public hospitals can be clinically used in a Shenzhen Hospital, according to a joint announcement by Guangdong NMPA […]
February 19, 2021

One Hundred Innovative Medical Devices have been Approved by NMPA

By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in 2014. This “Green Pathway” can […]
February 19, 2021

NMPA Released Five Guidelines in One Day

NMPA published five guidelines on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. For IVD Products Technical […]
February 18, 2021

16 Class III Devices Exempted from Clinical Trial

NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluation, and to […]
January 27, 2021
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225 Products Are No Longer Considered Medical Devices – Device Classification

The NMPA Medical Device Standardization Administration released the second batch of results for medical device classification, excluding 86 products as medical devices. It also identifies 60 Class III, 94 Class […]
January 27, 2021
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NMPA News Roundup December 2020

Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2020. These updates are presented by China Med Device, LLC, your partner in […]
January 18, 2021

Another AI Software Approved by NMPA

NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by […]
January 18, 2021

NMPA Released 12 Guidelines in One Day

The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines were put in […]
January 18, 2021
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NMPA Down-Classified Seven Class III Medical Devices and Eight Class II

The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Classification Catalog 2020 Complete List: 15 medical devices are […]
January 18, 2021

Feedbacks Needed for DR and Ultrasonic Diagnostic Software

The NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on […]