Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for July 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Eleven Class II & III Medical Devices to be Exempted from Clinical Trial
NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally accepted standard.
Eleven medical devices, including disposable intracranial retraction and fixation catheter, neuromonitoring endotracheal intubation equipment, are added to the proposed catalog. Also, product names and descriptions for additional eighteen medical devices are proposed to be amended. For the complete list, please click HERE
Clinical Pathway Recommended for these Medical Devices
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on July 14, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial. 139 medical devices in the fields of orthopedic surgery, dialysis, medical software, patient monitoring, anesthesia and physical therapy are affected.
To see the devices which opt to clinical evaluation exemption pathway instead of clinical trial, please click HERE
IVD IFU Guideline Issued for Feedback
NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The draft guideline is proposed to stipulate drug information such as the intended use, test methods, interpretation of test results, and precautions, which are important technical documents that direct users and clinicians to operate correctly, and accurately understand and apply test results.
For our comprehensive review, please click HERE
Medical Device Safety and Performance Guideline Issued
CMDE released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance” on July 13, 2022, elaborating the risk-based approach for medical device registration review. For more information, please click HERE
Guidelines & Standards
Eighteen Standards Issued in One Day
The NMPA published eighteen industry recommended standards, including those for dental amalgam blender and intraocular lens, on July 6, 2022, to guide manufacturers for local type testing and regulatory approval. Click HERE to see the list
Four Devices Obtain NMPA Innovation Approval in July
The NMPA granted Innovation Approvals to the following devices in July 2022. The list of 167 innovation approvals since the pathway established in 2014 is also issued. Click HERE to see more information