Blog

August 11, 2020

More Class II & III Medical Devices and IVDs to be Exempted from Clinical Trial

NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. It is an effort to implement risk-based clinical evaluation, and to […]
August 6, 2020

NMPA approved BRAF mutation detection kits

Oncology biomarker testing, as an important tool to guide the treatment of targeted therapy, has been one of the hottest areas for IVD manufactures world-wide. BRAF gene mutations are one […]
July 28, 2020

China PRER Due September 30, 2020: More Info to Help (II)

A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse […]
July 28, 2020

NMPA: Continued Efforts on IP Protection, Fair Competition and Anti-Bribery

In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market approval and post-market surveillance, to […]
July 28, 2020

NMPA: Fourteen Guideline Issued in July

NMPA published 14 guidelines in July 2020. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia and immunology, etc. Full List of Guidelines General Technical review guideline on […]
July 28, 2020

China PRER Due September 30, 2020: More Info to Help (I)

A Periodic Risk Evaluation Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event […]
July 23, 2020

China Medical Device UDI: First Batch Implementing October 1, 2020

NMPA “Rules for Unique Device Identification (UDI) System” Issued on August 27, 2019 mandates that the China UDI system for the first group of devices will take effect on October […]
July 16, 2020

Nine Orthopedic Standards Issued in One Day

NMPA issued nine orthopedic standards on July 9, 2020 to guide manufacturers for local type testing and regulatory approval. Their implementation date is June 1, 2021. YY/T 1701-2020 Medical Ti-6Al-4V/Ti-6Al-4V […]
July 14, 2020

NMPA News Roundup June 2020

Here’s the June 2020 China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese […]
July 9, 2020

NMPA is Revising Clinical Trial Approval Catalog

As innovative devices and first-of-kind products enter China market, NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical approval to […]
July 8, 2020

In One Day, Two AI Diagnostic Software Go into NMPA Fast-Track Channel

NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020: Innovation Status Zhiyuan Huitu: Assistance software for fundus diagnosis Priority Review Status Hangzhou Yitu: Assistance software […]
July 2, 2020

Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained NMPA Innovation Approval

NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020. Balloon Technology The product includes transcatheter […]