China Seeks Comments on Draft 2026 Class III Clinical Trial Approval Catalogue

On February 3, 2026, the Center for Medical Device Evaluation (CMDE) released the “Catalogue of Class III Medical Devices Requiring Clinical Trial Approval (2026 Revised Edition) (Draft for Comments)” for public consultation.

The draft catalogue revises the “Catalogue of Class III Medical Devices Requiring Clinical Trial Approval (2020 Revised Edition)” and proposes nine Class III medical device categories which that would be required to obtain regulatory approval before clinical trials can begin in China.

Stakeholders are encouraged to submit comments on the draft by March 5, 2026. Companies seeking support with feedback preparation may contact Cisema for assistance.

When Clinical Trial Approval Is Required

Under China’s medical device regulatory framework, not all clinical trials are subject to prior national-level approval. Clinical trial approval applies only under defined circumstances and is intended to address higher-risk technologies involving innovation or new clinical use.

A Class III medical device would require approval before trial initiation if its product name and description correspond to the name and description in this directory. The products within the directory can be characterized by:

• It introduces a new design, material, or operating mechanism
• It is intended for a new clinical indication compared with marketed products
• It presents a relatively high risk to the human body

Class III Device Categories Covered by the Draft

The device categories listed in the draft catalogue represent technology areas that are typically implantable, life-sustaining, or systemically interacting. In these areas, clinical performance is closely linked to device design, materials, and mechanisms, increasing the potential impact of innovation-related risks.

The draft catalogue identifies the following Class III medical device categories that would require clinical trial approval when novelty criteria apply:

• Implantable Cardiac Rhythm Management Devices: Implantable pacemakers, cardiac resynchronization therapy pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy defibrillators used to manage arrhythmias and certain heart failure conditions.
• Implantable Ventricular Assist Systems: Systems composed of implanted pumps, power supply components, vascular connections, and control units that provide mechanical circulatory support for advanced refractory heart failure.
• Implantable Drug Infusion Devices: Implantable pumps with refill and catheter access components used for long-term drug delivery, including intrathecal administration.
• Artificial Heart Valves and Intravascular Stents: Artificial heart valves, valve repair devices, and intravascular stents manufactured from polymer, biological, or metallic materials, with or without surface modification or drug components.
• Tissue-Engineered Medical Products Containing Living Cells: Passive implantable tissue-engineered medical products containing living cells where the primary mode of action is attributable to the medical device.
• Absorbable Internal Fixation Devices for Long Bones: Absorbable implantable devices used for internal fixation of long bone shaft fractures that adopt new designs, materials, or mechanisms.
• Implantable Brain–Computer Interface Medical Devices: Devices consisting of implanted electrodes, signal acquisition units, decoding software or equipment, and external control systems for neurological function reconstruction or enhancement.
• Implantable Atrial Shunt Devices: Nitinol-based double-disc devices implanted at the atrial septum to maintain interatrial shunting for pressure reduction in specific heart failure indications.
• Central Nervous System Injury Repair Devices: Devices primarily composed of materials such as collagen that provide a repair channel and supportive environment for central nervous system injury repair.

By defining these categories, regulators aim to apply the clinical trial approval mechanism more consistently across products and review pathways, while maintaining regulatory focus on higher-risk technologies.

Next Steps for Overseas Manufacturers

For overseas manufacturers, the draft catalogue has practical implications for how Class III clinical development in China should be planned. Manufacturers should therefore take a structured approach to assess potential impact of catalogue inclusion and adjust development strategies accordingly.

Key steps include:

• Confirm whether products fall within the listed categories
• Assess whether designs, materials, operating mechanisms, or intended uses are novel
• Incorporate potential clinical trial approval timelines into China development and registration plans

Addressing these issues early can help reduce regulatory uncertainty and avoid delays at the clinical trial initiation stage. For support with feedback submission or regulatory impact assessment, companies may contact Cisema directly.

Further Information

Explore Cisema’s China NMPA medical device consulting and registration services for regulatory strategy and implementation support.

References

• Notice on the Public Solicitation of Opinions on the “Catalogue of Class III Medical Devices Requiring Clinical Trial Approval (2026 Revised Edition) (Draft for Comments)” (Simplified Chinese).
• Draft Catalogue of Class III Medical Devices Requiring Clinical Trial Approval (2026 Revised Edition) (Simplified Chinese).