China 2025 Priority Review Catalogue for High-End Devices

1. Key takeaways

Two acceleration channels exist, judged on different logic: one on patents and originality, the other on catalogue entry and urgency.

• Two channels, two logics. Article 10 of Order 47 (promulgated 26 August 2021, effective 1 October 2021) applies special approval to innovative devices and priority approval to devices in urgent clinical need, judged respectively on patent and on catalogue entry.
• The catalogue is the main entry point for priority approval. The Priority Review Catalogue of High-End Medical Devices (2025 edition), published in 2025, defines the product scope, and entry is the first test.
• Priority approvals grew sharply in 2025: 25 devices approved, up 212.5 percent, for a cumulative 153 (2025 Annual Medical Device Registration Report, NMPA, 24 February 2026).
• The contrast with the innovation channel is marked. In 2025, 76 innovative devices were approved, up 17 percent, for a cumulative 361; the gap reflects faster expansion of the catalogue-based route.
• Announcement No. 63 of 2025 extends support across the lifecycle, covering medical robots, high-end medical imaging, AI devices and novel biomaterials.
• Priority status does not lower material standards: clinical evaluation, non-clinical research, technical requirements and quality system inspection are not reduced.

2. Legal basis

Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 5: supervision follows risk management, whole-process control, scientific oversight and social co-governance.
• Article 6: devices are classified by risk, with routine management for Class I, strict control for Class II and special measures for Class III.
• Article 14: seven categories of registration and filing material, the fourth being clinical evaluation material.

Opinions of the General Office of the State Council on Deepening Reform of Drug and Device Supervision (Guobanfa 2024 No. 53, issued 30 December 2024)

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

• Article 4: the NMPA administers registration and filing nationwide.
• Article 5: the CMDE reviews domestic Class III and imported Class II and III applications, and trial applications requiring approval.
• Article 10: special approval for innovative devices and priority approval for devices in urgent clinical need.
• Article 22: technical bodies shall establish a communication system.
• Article 23: the expert consultation system.
• Article 41: deficiencies notified in full at one time, answered within one year, otherwise review is terminated and approval refused.
• Article 120: fee items and standards follow State Council finance and pricing rules.

Normative and technical documents

• Priority Review Catalogue of High-End Medical Devices (2025 edition), published in 2025.
• Announcement on Measures to Optimise Whole-Life-Cycle Supervision and Support High-End Device Innovation (No. 63 of 2025, issued 27 June 2025).
• Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of 2018, published 2 November 2018, effective 1 December 2018).
• 2025 Annual Medical Device Registration Report (NMPA, 24 February 2026): 25 priority approvals, up 212.5 percent; 76 innovative approvals, up 17 percent.
• Reply to Suggestion No. 5388 of the Third Session of the 14th National People’s Congress (Guoyaoxjian 2025 No. 53): cumulative approvals of 361 innovative and 153 priority devices.
• Fees: domestic Class III initial registration RMB 153,600, variation RMB 50,400, renewal RMB 40,800; innovative device applications from small and micro enterprises are free.

Practical estimate. No official figure exists for the priority review cycle, the interpretation of catalogue boundaries, or provincial Class II fees. Some provinces publish RMB 40,670 per registration unit. Whether an entry covers a specific product should be confirmed through the communication channel before acceptance.

3. Expert insights

The two channels use different coordinate systems. Article 10 places them side by side, but their entry conditions point at different dimensions.

The table explains the most common error: preparing priority material with the innovation mindset, rehearsing patent arguments without checking catalogue entry. Patent material is not decisive for priority approval.

The 212.5 percent growth is a signal about resource allocation. Read together, the two rates do not say which channel is better; they show that the catalogue-based channel expands more readily. The innovation entry point is a patent test with stable criteria, so growth is bounded by corporate research spending. The priority entry point is a catalogue that can be adjusted, so growth is driven from the regulatory side, as Announcement No. 63 of 2025 reflects. The implication is to assess both channels and re-check priority eligibility as the catalogue is updated.

A catalogue brings predictability and boundary problems. The benefit is that entry can be judged at project initiation without waiting for a review outcome. The difficulty is the boundary: entries are described by field and technical feature, and a product may span fields or sit at the edge of a description. Three situations recur: technology spanning two fields; a core technology inside the catalogue while the finished device falls outside the description; and models in one registration unit in different entry status. The comparison should be recorded in writing, covering entry text, product features, agreement or difference, and conclusion.

Priority status changes sequence and resources, not standards. After obtaining priority eligibility, none of the following is reduced: clinical evaluation material under Article 14 of the regulation and Articles 33 to 36 of the order; non-clinical research under Article 28; technical requirements under Article 26; and quality system inspection under Articles 47 to 49. The cost of misreading is concrete. A company lowers its standard because of priority status, is asked to supplement during correction, and correction is bounded by Article 41, with all deficiencies notified at once and a one-year window before review terminates. The fast channel becomes the source of delay.

Channel choice should rest on eligibility, not on speed expectations. Three steps settle it: check the patent window, which decides special approval; check the catalogue or urgent need, which decides priority approval; and check whether either filing point fits the schedule. Only then should a choice be made. For special approval, filing before the first registration application is often more decisive than any difference in speed.

4. Practical recommendations

• Screen both channels on one project sheet, assessing patent conditions and catalogue entry in parallel without presetting a conclusion.
• Record the catalogue comparison in four columns: entry text, product features, agreement or difference, and conclusion.
• Use the 2025 edition, and re-check entry status at key milestones in longer projects.
• Include lifecycle measures in the assessment, covering research, standards, communication and post-market steps under Announcement No. 63.
• Separate priority status from documentation standards, making clear internally that requirements are unchanged.
• Schedule corrections from the one-year limit, tracking material, owner, source and days weekly.
• Use the communication channel to settle boundaries under Article 22 before acceptance.
• Budget on the benchmarks of RMB 153,600 initial, RMB 50,400 variation and RMB 40,800 renewal, checking any small or micro enterprise relief separately.

5. Verification checklist

• □ Both channels have been assessed in parallel: special approval on patents, priority approval on catalogue and urgency.
• □ The 2025 priority catalogue is held and confirmed as current.
• □ The four-column catalogue comparison is complete and signed.
• □ Special cases have been judged individually: multi-field technology, device versus core component, and models in one unit.
• □ Patent conditions and the window have been checked separately (Announcement No. 83).
• □ Filing point requirements for both channels are confirmed against the project schedule.
• □ Priority status reduces no clinical, non-clinical, technical or inspection obligation.
• □ Lifecycle measures applicable to the product under Announcement No. 63 are listed.
• □ Uncertain catalogue boundaries are confirmed through the communication channel (Article 22).
• □ The response plan follows the one-year limit (Article 41).
• □ Fees follow the benchmarks of RMB 153,600, RMB 50,400 and RMB 40,800, with Class II verified provincially.
• □ Figures keep the distinctions: 2025 priority 25 (up 212.5 percent), innovative 76 (up 17 percent); cumulative 153 and 361.

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 NMPA Class II/III registrations and filing procedures, coordinates typetesting, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com