February 26, 2021
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
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
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
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 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
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
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
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
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
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
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
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 […]