Guobanfa 2024 No. 53: 24 Reform Measures and Two-Stage Goals

1. Key takeaways

The Opinions of the General Office of the State Council 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) was issued on 30 December 2024, setting out 24 reform measures across five areas.

• Two stages are set: a milestone for 2027 and an overall goal for 2035. Their wording is not within the provisions verified here, so no paraphrase is offered.
• Item (1) proposes four working methods — early intervention, one enterprise one policy, whole-process guidance, and linkage of research and review. This is the most directly operational element for enterprises.
• It is a State Council policy, not a departmental rule citable as a filing basis, yet it determines where supervisory resources go, and therefore review pace and channel design.
• Implementation is already visible in 2025 instruments: Announcement No. 63 of 2025 on lifecycle supervision supporting high-end device innovation (27 June 2025) and Announcement No. 30 of 2025 on imported devices produced by Chinese entities (17 March 2025).
• The data side has responded: 76 innovative devices approved in 2025 (up 17%) and 25 priority-reviewed devices (up 212.5%).

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 is responsible for supervision nationwide. Article 5: risk management, whole-process control, scientific supervision, social co-governance. Article 13: Class I filed, Class II and III registered.

State Council document. Opinions of the General Office of the State Council 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, with goals for 2027 and 2035; item (1) sets out early intervention, one enterprise one policy, whole-process guidance and linkage of research and review.

Departmental rules and normative documents. 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 10: special approval for innovation; priority review. Article 22: communication mechanism. Article 23: expert consultation.

Measures on Optimising Lifecycle Supervision to Support Innovation in High-End Medical Devices (Announcement No. 63 of 2025), issued 27 June 2025. Matters Concerning Further Adjusting and Optimising the Production in China of Imported Medical Device Products (Announcement No. 30 of 2025), issued 17 March 2025. Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of 2018), promulgated 2 November 2018, effective 1 December 2018.

Practical estimate. The titles of the five areas, the 24 measures and the wording of the two goals are not held here as verified text. The description is limited to structural information and the four working methods in item (1); citation should follow the full text on gov.cn.

3. Expert insights

The level of the document determines how it is used: it sets direction, not clauses.

Citing a policy document as a filing basis is a misuse: a dossier that refers to Guobanfa 2024 No. 53 instead of a provision is not thereby supported. Its value is anticipation of where resources go and which channel speeds up.

Four working methods, four executable actions.

The first and fourth matter most: early intervention moves contact forward, so waiting for a complete dossier defeats the purpose, and linkage means reserving a window for review feedback.

Two staged goals extend compliance planning to a decade.

The wording of the goals is outside the verified scope (practical estimate). The two dates signal a directional arrangement over more than a decade: a ten-year portfolio built on current cycles will fall out of step, because faster review means recalculating the assumptions.

Two 2025 announcements are the landing points in devices.

The two announcements answer two directions in the Opinions: a change in industrial organisation, and a strengthening of the innovation support mechanism. Both appeared within six months, showing fast execution rather than a document tied to principle.

The data side has already responded.

The contrast is telling: resources tilt towards high-end devices matched against a catalogue, since priority review runs on a predictable matching logic that advances in batches, while innovative review runs case by case on technical maturity.

Continuous catalogue adjustment is whole-process control at the base layer. Four batches and 123 entries since 2020 have changed management classes, and with them acceptance level, filing route and cost structure.

Long-term planning should treat catalogue adjustment as a variable: GRZAN checks the sub-catalogue’s recent history at project start before judging how stable a classification will be.

4. Practical recommendations

• Use the policy document to forecast, not to cite; keep the dossier basis on the Regulation, rules and announcements.
• Re-time communication around the four methods, moving it from after the dossier is complete to key development milestones, and reserve an iteration window for feedback.
• Prepare capability statements covering R&D, quality system status and pipeline (practical estimate).
• Recalculate the pipeline over ten years: the 2027 and 2035 goals mean review efficiency keeps moving, so plans need staged review.
• Track follow-up instruments to Announcements No. 63 and No. 30, since implementation comes through further documents.
• Assess the priority review channel: 25 approvals in 2025 at 212.5% growth, with a predictable matching logic.
• Run an annual catalogue tracking routine, rechecking the classification conclusion for each product’s sub-catalogue.
• Watch the regional layout of the Chunyu Action pilots in 11 provinces for local support measures (practical estimate).

5. Verification checklist

• □ Full text of Guobanfa 2024 No. 53 obtained; five areas and 24 measures confirmed
• □ Official wording of the 2027 and 2035 goals confirmed
• □ Original text of the four working methods in item (1) verified
• □ Pipeline schedule recalculated against the two stages
• □ Communication moved forward to development milestones (Article 22)
• □ Eligibility assessed for both innovative review (Announcement No. 83 of 2018) and priority review
• □ Follow-up documents to Announcements No. 63 (27 June 2025) and No. 30 (17 March 2025) tracked
• □ Adjustment history of the sub-catalogue checked (four batches, 123 entries)
• □ Dossier cites provisions rather than policy documents
• □ Site in one of the 11 pilot provinces, local measures understood
• □ Annual review routine tracking implementation and review efficiency

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