NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020. Clinical data generated outside
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med Device, LLC, your partner in
The NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide if clinical trial is necessary
Guangdong government published three documents on July 19, 2021 for feedback: Key Points for Application Materials for Import and Use of Hong Kong and Macau Medical Devices by Designated Institutions
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device LLC, your partner in Chinese market access.
China NMPA released eight draft clinical guidelines for urgent feedback to support the new overarching State Order 739, the “Regulation for Medical Device Administration and Supervision”. It covers the full
The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021. Complete List Medical Device Clinical
October 12, 2020 — Hainan Province, China. This real-world data study of China clinical evaluation in the Hainan pilot zone will help urgent need medical devices. For example, it allows
Going through China’s medical device clinical trial phases can be painstaking in terms of the cost and time. While more and more clinical exemptions have been issued by China’s NMPA
NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical
In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results
For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report. In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with
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