China Innovative Medical Devices Entering NMPA Special Review Procedures in October 2024

China innovative medical devices entering the special review procedures have been announced by the National Medical Products Administration (NMPA) on October 18, 2024. This review follows the framework established in the "Special Review Procedures for Innovative Medical Devices" (NMPA Announcement No. 83 of 2018). Seven innovative medical device projects have been accepted for entry into the special review process. The public announcement period runs from October 18 to November 1, 2024, during which stakeholders may raise objections regarding the selected applications.

Products Selected for Special Review

The innovative devices granted access to the special review process include:

Liver Hypothermic Perfusion System – Hangzhou Life Perfusor Medical Inc.
Cardiac Pulsed Electric Field Ablation Catheter – Shenzhen Pulsecare Medical Technology Co., Ltd.
Wrist Joint Prosthesis System – Suzhou MicroPort Medical Technology Co., Ltd.
Medical Carbon Dioxide Contrast Pressure Injection Kit – Beijing Advanced Medical Technologies Co., Ltd.
Interventional Left Ventricular Assist System – Abiomed Inc.
Disposable Cardiac Pulsed Electric Field Ablation Catheter – Shanghai MicroPort EP MedTech Co., Ltd.
Puncture Surgery Navigation Positioning System – Hangzhou Weiyin Technology Co., Ltd.

Special Review Process Highlights

Early Submission and Priority Review: Applicants seeking innovative approval must submit an Application Form for Special Review of Innovative Medical Devices before applying for registration of Class II or III medical devices. The NMPA evaluates the submitted materials to ensure compliance with Article 2 of the Special Review Procedures, which outlines the criteria for technological innovation, clinical value, and product development.
Provincial and National-Level Review: For domestic applicants, the initial application is submitted to the provincial medical products administration (MPA) for preliminary review. Approved, applications are then forwarded to the NMPA for final evaluation. For international applicants, submissions go directly to the NMPA.
Expert Review: The NMPA's Innovative Medical Device Review Office assembles a team of experts to review applications. If all requirements are met, the application will be accepted to enter the special review process. The office may reject applications for reasons such as falsified materials, unclear intellectual property status, or lack of significant innovation.
Public Announcement and Objections: Selected applicants and product names are publicly announced on the NMPA website for at least 10 days. Stakeholders can raise objections during this period, which the NMPA will investigate before finalizing decisions.
Ongoing Communication and Support: Throughout thedevelopment and review phases, the NMPA provides dedicated communication channels to assist manufacturers with technical, safety, or clinical trial issues. This proactive approach helps prevent unnecessary delays in the regulatory process.
Post-Approval Priority: Once the device passes the special review and is approved for registration, it receives priority throughout the registration process. Quality assurance inspections and clinical trials for these devices are expedited, with the provincial drug regulatory authority assigning dedicated personnel for ongoing communication and support.

Impacts on Regulatory and Quality Assurance Teams

Accelerated Timelines: Devices in the special review process benefit from faster regulatory processing, but this requires teams to be prepared with complete, well-documented submissions. Regulatory affairs teams must ensure that all application materials, including patent rights, technical documentation, and product development data, are meticulously prepared to avoid delays.
Increased Scrutiny: While the review process is expedited, NMPA standards remains stringent. Quality assurance managers must ensure thorough risk analysis and compliance with safety and performance requirements. Additionally, documentation on product innovation, intellectual property, and clinical application value must be robust.
Strategic Planning for Objections: Companies should monitor for potential objections during the public announcement period. Regulatory teams should prepare responses if an objection arises and ensure compliance with regulatory requirements to prevent complications.