China 2025 Medical Device Registration Report: Behind 76 Innovative Approvals

1. Key takeaways

The 2025 Annual Medical Device Registration Work Report was published by NMPA on 24 February 2026. In 2025, 76 innovative medical devices were approved, up 17% year on year.

• 25 priority-reviewed devices were approved in 2025, up 212.5%. The growth gap between the two accelerated channels is wide.
• Cumulative approvals stand at 361 innovative devices and 153 priority devices, on the basis of the reply to Recommendation No. 5388 of the 14th NPC (Guoyaoyaojian 2025 No. 53) at the time it was given.
• Since 2020, four batches covering 123 catalogue adjustments have been published, so the classification rules remain in motion.
• In 2025 the Chunyu Action pilot ran in 11 provinces with strong device innovation capability, moving supervisory resources down to the regional level.
• The growth gap supports one reading: resources are accelerating towards the priority channel, where eligibility can be matched against a catalogue and advanced in batches, while innovative review still depends on the maturity of each case.

2. Legal basis

Administrative regulation. Medical Device Supervision and Administration Regulation (State Council Order No. 739), promulgated 9 February 2021, effective 1 June 2021. Article 3: NMPA supervises devices nationwide. Article 5: risk management, whole-process control, scientific supervision, social co-governance. Article 6: classification by risk. Article 13: Class I filed, Class II and III registered.

State Council document. Opinions on Deepening Reform of Drug and Medical Device Supervision in All Respects and Promoting High-Quality Development of the Pharmaceutical Industry (Guobanfa 2024 No. 53), issued 30 December 2024: five areas, 24 measures, goals for 2027 and 2035.

Departmental rules. Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), promulgated 26 August 2021, effective 1 October 2021.

• Article 5: the NMPA device review centre handles technical review of domestic Class III and imported Class II and III applications, changes and renewals.
• Article 6: provincial drug administrations handle domestic Class II review and approval, and quality system inspection for domestic Class II and III.
• Article 8: Class I filed at municipal level, Class II with the province, Class III with NMPA. Article 10: special approval for innovation; priority review. Article 22: communication mechanism.

Normative documents and data sources. 2025 Annual Medical Device Registration Work Report (NMPA, 24 February 2026): 76 innovative devices approved, up 17%; 25 priority devices, up 212.5%. Reply to Recommendation No. 5388 of the 14th NPC (Guoyaoyaojian 2025 No. 53): 361 innovative and 153 priority devices cumulatively, four batches and 123 catalogue entries since 2020, Chunyu Action pilots in 11 provinces in 2025. Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of 2018), 2 November 2018, effective 1 December 2018. Measures on Optimising Lifecycle Supervision to Support Innovation in High-End Medical Devices (Announcement No. 63 of 2025), issued 27 June 2025.

Practical estimate. Statistical items beyond the figures verified above — approvals by class, the import to domestic ratio, review time performance — are not held here. The 361 and 153 counts are as at the reply and may have grown since, so any citation must state the reference date.

3. Expert insights

17% and 212.5% show where resources are going.

In absolute terms 212.5% is smaller than the 76 on the innovative channel, but the rate shows the marginal shift: once inside the priority catalogue the path is predictable and resources move by batch, whereas innovative review depends on the maturity, evidence and patents of each project.

For enterprises the difference has decision value: where a product could qualify for both, the catalogue route is more certain.

The stock of 361 and 153 changes the relative value of innovation.

An annual 76 against a stock of 361 means the channel has moved from scarce to routine but high-threshold: entry is no longer the differentiator, but the review resources obtained inside it and the use of market exclusivity after approval.

Four batches and 123 entries show classification is a moving variable.

The fourth row is the most overlooked. Refinement affects more than the registration route: UDI scope is fixed at secondary category level, so when the catalogue moves the conclusion is recalculated.

The 11-province Chunyu Action moves supervisory resources to the regions. The regional meaning has three layers.

For a company in a pilot province this is usable: combining communication (Article 22) with the pilot mechanism beats the ordinary queue (practical estimate).

The data echo the two stages of Guobanfa 2024 No. 53.

With the Opinions issued on 30 December 2024 and 2025 data already moving, execution is tight. The priority channel evidences the four working methods of item (1), since gains appear first where products advance in batches.

Three assumptions to recalculate.

The third causes the most concrete loss: if a determination goes unchecked, development may finish to the old class just as an adjustment raises it, and requirements and cycle start again.

4. Practical recommendations

• Assess both accelerated channels in parallel against Announcement No. 83 of 2018 and the 2025 priority catalogue, without assuming innovation comes first (Article 10).
• Run a catalogue match before choosing priority review: 25 approvals at 212.5% growth, with a highly predictable route.
• State the reference date for cumulative figures, as 361 and 153 are as at the reply.
• Set an annual catalogue review against four batches and 123 entries, re-applying for classification confirmation where needed (Article 23).
• Tie UDI scope to the catalogue review, recalculating at secondary category level after any adjustment (Announcement No. 22 of 2023).
• Approach the Chunyu Action directly if in a pilot province, combining communication (Article 22) with the mechanism (practical estimate).
• Recheck the pipeline against the two stages; linear extrapolation misleads.
• Track the rest of the Report and verify other statistical items against the source before citing them.

5. Verification checklist

• □ Report obtained (NMPA, 24 February 2026)
• □ 76 innovative approvals and +17% cited with source and date
• □ 25 priority approvals and +212.5% cited with source and date
• □ 361 and 153 marked as at the reply (Guoyaoyaojian 2025 No. 53)
• □ Eligibility checked on both channels in parallel
• □ Catalogue match completed against the 2025 priority catalogue
• □ Pipeline reviewed against the 2027 and 2035 goals
• □ Annual catalogue review routine in place (four batches, 123 entries)
• □ UDI scope recalculated after adjustments (15 categories, 103 Class II varieties)
• □ Site confirmed in one of the 11 pilot provinces, with local arrangements understood
• □ Support measures under Announcement No. 63 (27 June 2025) built into channel assessment
• □ Other statistical items verified against the Report before citation

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages adverse event monitoring and recall filings with NMPA, maintains UDI compliance, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com