CMDE Releases Implementation Rules for Innovative and Priority Medical Device Review

CMDE released implementation rules for innovative and priority medical device review as China officially implemented two new regulatory measures on April 18, 2025. Issued by the Center for Medical Device Evaluation (CMDE) under the NMPA, these policies enable earlier engagement with regulators, accelerate approval timelines, and enhance transparency via the eRPS system. International manufacturers should take note of localized clinical data requirements, patent validity constraints, and product classification criteria. The updates reflect China’s continued efforts to streamline medical device registration and may influence market entry strategies for overseas companies.

Policy Background

This reform is a specific measure to implement the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of the Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (State Office Document No. 53 of 2024). The introduction of these rules reflects three significant shifts:

From passive evaluation to proactive guidance: Establishing a working mechanism of "early intervention, dedicated personnel," providing professional guidance during the product development phase. The CMDE will assign dedicated personnel to interface with innovative projects, which can save companies an average of 3-6 months of R&D time.
From single evaluation to full-process service: Improving the "pre-evaluation - formal evaluation - post-market supervision" full-chain service system. Electronic declarations through the eRPS system increases evaluation transparency by more than 40%.
From uniform approval to classified acceleration: Creating a "green channel" for innovative products and products urgently needed in clinical practice. Data shows that innovative medical devices approved through special review in 2024 had an average approval time reduced to 180 days, speeding up the process by 50% compared to the regular process.

Special Review of Innovative Medical Devices

Core Policy: Focusing on Technological Innovation and Clinical Value

Technological Originality:
The core technology of the product must be first applied in China.
It must demonstrate significant progress over existing technologies.
Clinical value needs to be supported by evidence-based medical research.
Intellectual Property Requirements:
China patent is required over substantially all of the primary mechanism of action.

There is a 5-year time window for application, calculated from the date of patent authorization announcement.

(Author's note: this requirement for a China patent is often a key threshold barrier for international companies seeking to utilise the innovative pathway.)

R&D Evidence Chain:
Complete laboratory research data.
Necessary animal test data.
If clinical data are available, they must comply with Chinese GCP requirements.

Comparison of Evaluation Efficiency

Table 1: Optimization of Special Review Efficiency for Innovative Medical Devices

Stage Standard Limit Special Channel Limit Reduction Ratio Formal Review 20 working days 10 working days 50% Expert Review 60 working days 30 working days 50% Technical Evaluation 90 working days 60 working days 33% Total Approval Time 170 working days 100 working days 41%

Innovative products approved through review will enjoy policy support such as priority evaluation and early technical guidance, with registration cycles potentially shortened by 30%-50%.

Opportunities:

Market First-Mover Advantage: Products approved through innovative review can shorten the average market entry time by 6–12 months.
Policy Dividends: Enjoy the convenience of priority evaluation and other preferential measures.
Brand Premium: The "Innovative Medical Device" label enhances product market recognition.

Challenges:

Patent Layout Strategy: Need to plan China patent applications 3–5 years in advance.
Clinical Data Requirements: Overseas data need to undergo an assessment suitability for Chinese populations.

Policy Scope and Requirements:

Products for diagnosis or treatment of rare diseases, malignant tumors with significant clinical advantages.
Products for diagnosis or treatment of diseases particularly prevalent and multiple in the elderly population and for which there are currently no effective diagnostic or therapeutic methods.
Products specifically for children with significant clinical advantages.
Medical devices urgently needed in clinical practice and for which no similar products are approved in China.
Medical devices included in major national science and technology projects or key national research and development plans.

Products included in priority approval will be given priority in technical evaluation and can quickly submit applications through the eRPS system, greatly shortening approval time.

Table 2: Comparison of Implementation Effects of Priority Approval

Indicator Regular Approval Priority Approval Improvement Margin Average Evaluation Time 180 days 60 days 67% Communication Efficiency 30 days/time 10 days/time 67%

Strategic Considerations for International Companies

Advantages:

Rapid Response to Needs: Average evaluation time shortened to 60 working days.
Optimized Communication Mechanism: Communication efficiency increased by 40% through the eRPS system.

Difficulties:

Proof of Clinical Advantage: Need to provide detailed comparative data.
No Similar Products Domestically: Need to prove through search reports that similar products have not been approved domestically.

Strategies for International Companies to Respond

Accurate Product Category Positioning

Special Review: Suitable for products with strong technological disruption and global patent layout.
Priority Approval: Suitable for products filling domestic clinical gaps.

Strengthen Compliance Preparation

Intellectual Property Layout: Apply for Chinese patents in advance, pay attention to the 5-year time limit.
Data Localization: Overseas data need to supplement Chinese subgroup analysis or cooperate with local institutions to conduct trials.

Make Good Use of Policy Tools

Early Communication Mechanism: Submit pre-evaluation meeting applications through the eRPS system to clarify technical requirements.
Rapid Response Process: Establish an efficient internal team to ensure the timeliness of priority approval applications.

Use in-China Vendors

CRO Cooperation: Ensure clinical trials comply with Chinese GCP standards.
Regulatory Support: Rely on experienced agencies to review and complete documentation and to manage regulatory risks.

Further Information

To read the original announcement about the implementation rules for innovative and priority medical device review released by the Center for Medical Device Evaluation (CMDE), please click here.

If Cisema can support your China clinical trial or regulatory submissions, please connect with us.