NMPA’s New Guidance for Priority Medical Device Approval

NMPA published the “Implementation Rules for the Priority Approval Review of Medical Devices” on April 18, 2025. The document is based on the “Medical Devices Priority Approval Review Procedures” effective from January 1, 2017, detailing the path-to-market for urgently needed medical technologies.

Significance of the Implementation Rules

The document consists of seven chapters and 33 articles, covering General Provisions, Priority Application and Formal Review, Review of Priority Applications for Urgent Clinical Needs, Review of Priority Applications for National Major Science and Technology Projects, Confirmation of Review Opinions, Objection Handling, among others.

The document states that priority review applications for medical devices that are used for the diagnosis or treatment of rare diseases or malignant tumors with significant clinical advantages; for the diagnosis or treatment of diseases specific to or prevalent among the elderly where no effective methods currently exist; for pediatric use with clear clinical benefits; or for urgent clinical needs where no similar products have been approved for registration in China, will adopt an expert review system. Experts are randomly and blindly selected through an expert management system.

For priority review applications involving medical devices listed under national major science and technology projects or national key R&D programs, the Center for Medical Device Evaluation (CMDE) is responsible for the review. When necessary, the Department of Medical Device Registration Administration of NMPA will seek opinions from relevant authorities such as the Ministry of Science and Technology and the National Health Commission before issuing the final review opinion.

For how to interact with NMPA for your priority device. please click HERE

Step-by-Step Guidance: How the Implementation Rules Work

This document establishes a dual-track system for priority approval of medical devices in China. It emphasizes transparency, expert involvement, conflict-of-interest management, and communication with applicants, aiming to accelerate the registration of urgently needed and clinically advantageous medical devices:

General Provisions

To meet clinical needs and improve the efficiency of medical device approvals, these rules were formulated in accordance with the Priority Approval Procedure for Medical Devices. The rules apply to devices that offer significant clinical advantages in treating rare diseases, malignant tumors, conditions specific to the elderly or children, or devices urgently needed but not yet approved in China.

There are two paths for priority review:

1. Expert Review Path: For devices treating rare diseases, cancers, elderly/children-specific diseases, or urgently needed products with no domestic equivalent, the application is reviewed by experts organized by national academic societies (e.g., Chinese Society of Biomedical Engineering).
2. CMDE Review Path: For devices included in major national science or R&D programs, the CMDE conducts the review.

The Priority Review Office (PRO) is set up within CMDE to handle daily operations, including:

• Conducting preliminary reviews of applications;
• Organizing expert evaluations for qualified cases;
• Publishing proposed approvals;
• Notifying applicants of final decisions.

Application Submission and Preliminary Review

Applicants must submit a Priority Approval Application Form and supporting documentation at the time of product registration.

The PRO Secretariat will perform a formality review based on set requirements:

• Complete and accurate application forms;
• For devices in the expert review category, documentation must include disease prevalence data, current treatment limitations, and evidence of clinical advantage;
• For urgent-need devices, documents must show the product is not yet approved in China and that no effective alternatives exist;
• For products under national science initiatives, proof of inclusion in these programs is needed.

Expert Review for Clinically Urgent Devices

This chapter applies to cases under the expert review route.

• Expert panels are randomly selected using a management system.
• Experts must meet specific qualifications, including having senior technical titles and no conflicts of interest.
• They must recuse themselves if they have participated in the product’s development or have a conflict of interest.

Upon acceptance of the application:

• The PRO Secretariat requests an expert review meeting from the academic society.
• The society convenes the panel, which reviews the application and submits individual and group opinions.
• The group decision is either “approved” or “not approved,” documented in official forms.

Confidentiality is strictly enforced throughout the review process.

Review of National Science Initiative Applications

For devices falling under national R&D projects, CMDE completes the review within five working days.

If there is ambiguity regarding the device’s status under a national program, the NMPA may consult with the Ministry of Science and Technology or the National Health Commission. The consultation time is not included in the review period.

Confirmation of Review Opinions

• A monthly meeting is held to confirm the compliance of expert reviews.
• Applications proposed for priority approval are publicized on the CMDE website for five working days.
• The applicant is informed of the final decision afterward.

Objection Handling

Objections can be filed under two conditions:

1. If a third party disagrees with the proposed priority approval during the public comment period.
2. If the applicant disagrees with the review decision.

Objections must be submitted in writing using the official form within specified timeframes (during the public notice period or within 10 working days of notification).

• For expert-reviewed cases, academic societies handle the objections and may consult experts for technical matters.
• For national science initiative cases, CMDE handles the objections.
• The final resolution is confirmed by the PRO office.
• Duplicate objections on the same issue will not be accepted.

Supplementary Provisions

• Priority-approved applications are placed in a separate queue and reviewed ahead of others.
• Applicants can request communication meetings via the eRPS system during the technical review phase.
• Communication can be initiated for major technical or safety issues, responses to deficiency letters, or other important topics.