China NMPA Newsletter – June 2024

NMPA Medical Device New Approvals in May 2024

In May 2024, NMPA approved 265 medical devices, including 40 Class III imported products, 27 Class II imported products, and 197 Class III domestic products.

Below is a list of approved Class III and Class II imported products in May 2024.

NMPA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites On June 14, 2024, China NMPA has released this new guideline. This guideline aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health. READ MORE

The FAQ for China Submission highlights updates in biological evaluation standards for passive medical devices, including the new GB/T 16886.1 that focuses on physicochemical characterization and selective long-term toxicity tests. It also addresses the conditions under which cytotoxicity testing, dual-route exposure, and chemical characterization are required, emphasizing that equivalence comparison and specific evaluations are essential for ensuring device safety.

• Why Is The Extraction Period Typically 24 Hours In China For Cytotoxicity Testing?
• What Are The Key Focus Areas In The Evaluation Of Acute, Subacute, Subchronic, And Chronic Toxicity, And Can These Tests Replace One Another? If A Product Has Undergone Acute Systemic And Subchronic Systemic Toxicity Tests, Can Subacute Systemic Toxicity Tests Be Waived? Under What Circumstances Is It Not Possible To Waive Subacute Systemic Toxicity Testing?
• GB/T 16886.11-2021 Adds Tests For Subchronic Systemic Toxicity Evaluation With Dual-route Exposure. Which Products Are Suitable For Dual-route Exposure, And Can Dual-route Exposure Methods Represent Subchronic Toxicity Under Polar And Non-polar Extraction Conditions?
• For Subchronic Systemic Toxicity Studied Via Implantation, What Is The Basis For Determining The Implantation Dose, And How Is The Conversion Between Animals And Humans Handled?
• When Combining Subchronic And Implantation Tests In One Project, What Factors Need To Be Considered, And How Can It Be Achieved?
• Under What Conditions Can The Extraction Liquid Of Dressings Be Accepted After PH Adjustment, Centrifugation, And Other Treatments? Should Samples Be Characterized Before And After Treatment, And What Key Indicators Should Be Focused On?
• How Is The Endotoxin Limit For Wound Dressing Products Determined?
• GB/T 16886.1-2022 Includes Implantation In The Biological Evaluation Of Dressings. How Should Implantation Tests For Dressings Be Conducted, And How Should Sampling (e.g., Hydrocolloid Dressings) And The Implantation Site Be Selected?
• Do All Medical Devices Require Chemical Characterization?
• What Factors May Affect Biocompatibility Risk When Using Biological Test Data From Similar Devices For Biological Evaluation?
• Can Products Made From Materials Conforming To YY 0341.1 Appendix B Be Exempted From Biological Evaluation?
• How Should The Evaluation Of New Items In The Endpoint Table Be Considered After The Implementation Of The New GB/T 16886.1, And What Is The Background Of The ISO Revision?

• Guidelines For Medical Device Usability Engineering Registration Review (March 19, 2024)
• Application Note On Guideline For The Review Of Medical Device Usability Engineering Registrations (October 8, 2024)
• Guidelines For Review Of Medical Device Usability Engineering Registrations (March 27, 2024)

UK-China Medical Device Access to China

Session 1 -Navigating Medical Device Lifecycle and Compliance in China

A session on UK-China Medical Device Access to China is scheduled for January 17, 2024, focusing on navigating the medical device lifecycle and compliance in China. The agenda includes the introduction and launch of a report, an overview of medical device regulation in China for UK SMEs, strategies to expedite premarket approvals, and insights into post-market surveillance and compliance obligations. The session aims to provide information on key regulations, approval processes, and best practices for UK medical device companies seeking access to the Chinese market. The event will conclude with a Q&A session.

Session 2-Targeting Unmet Medical Needs in China’s Growing Market

Session 2 on targeting unmet medical needs in China’s growing market, features an agenda encompassing an introduction, an exploration of the landscape of unmet medical needs in China, with a focus on areas where UK MedTechs can excel, discussion of “Green Channels” for market access of UK medical devices to China, highlighting expedited pathways for entry into the Chinese market, and concluding with a Q&A session.

Please click here to review the record of BradyKnows webinar and short videos.