China 2025 Catalogue of Devices Exempt from Clinical Evaluation

1. Key takeaways

The exemption catalogue shortens the clinical evaluation route but does not remove the duty to submit clinical material, and it is organised by product description rather than trade name.

• The legal effect is exemption from clinical evaluation, not exemption from clinical material. Under Article 36 of Order 47 (promulgated 26 August 2021, effective 1 October 2021), the comparison route still needs a comparison with a same-variety device, an analysis of its clinical data, and scientific evidence with a conclusion on differences.
• The current version is the 2025 catalogue: NMPA Notice No. 19 of 2025, published 12 May 2025 and effective on publication, with 1,047 items, 28 additions and 25 revised descriptions.
• Entries are defined by product description, not by trade name. A similar name does not establish correspondence; structure and intended use must be checked sentence by sentence.
• The catalogue is adjusted over time. Article 34 of Order 47 gives the NMPA power to formulate and adjust it, so a change in description or intended use may remove correspondence.
• Not being listed does not mean a trial is mandatory. Article 25 of Decree 739 provides two routes, and same-variety comparison is one.
• IVDs follow a parallel catalogue. IVDs follow Order 48 and the 2025 catalogue of IVDs exempt from clinical trials, published 24 June 2025; the two catalogues cannot be cross-referenced.

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 14: seven categories of registration and filing material, the fourth being clinical evaluation material.
• Article 24: the two situations exempt from clinical evaluation.
• Article 25: the two routes, namely comparative analysis of same-variety clinical data and clinical trials.

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

• Article 33: principles of clinical evaluation.
• Article 34: the two exemption situations, and the body that formulates and adjusts the catalogue.
• Article 35: formulation and application of clinical evaluation guidelines.
• Article 36: the material required under the comparison route and under the trial route.
• Article 41: deficiencies notified in full at one time, answered within one year, otherwise review is terminated and approval refused.
• Article 121: IVD registration and filing follow Order 48.

Provisions for the Administration of In Vitro Diagnostic Reagent Registration and Filing (SAMR Order No. 48, promulgated 26 August 2021, effective 1 October 2021)

Normative and technical documents

• Catalogue of Medical Devices Exempt from Clinical Evaluation (2025) (NMPA Notice No. 19 of 2025, published 12 May 2025, effective on publication): 1,047 items, 28 added, 25 descriptions revised.
• Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025) (published 24 June 2025).
• Announcement on Medical Device Registration Application Materials and Approval Document Format (NMPA Announcement No. 121 of 2021, published 29 September 2021, effective 1 January 2022).
• Announcement on IVD Registration Application Materials and Approval Document Format (NMPA Announcement No. 122 of 2021, published 29 September 2021, effective 1 January 2022).

Practical estimate. Provincial Class II fees differ, and published sources show RMB 40,670 per registration unit for an initial Class II registration in some provinces. Neither the hours needed for entry comparison nor the preparation cycle for comparison material has an official figure; both must be verified with the provincial medical products administration, finance department and reviewing office at project initiation.

3. Expert insights

The catalogue exempts the evaluation activity, not the burden of proof. Entry means the clinical evaluation need not be completed through a trial or a full same-variety analysis. Article 14 of Decree 739 still lists clinical evaluation material among the seven categories, and that duty survives entry. The third item in the table is where deficiencies concentrate, usually because exemption is read as exemption from the clinical part of the file.

1,047 is a count of entries, not of covered products. One entry may cover many models, and one product may touch several entries. Name matching is therefore insufficient: the 2025 revision changed 25 descriptions and boundaries are tightening, so a product whose structure or intended use exceeds the entry does not correspond to it. The comparison should leave a four-column record of catalogue text and entry number, product content, agreement, and basis.

The 28 additions allow earlier projects to be re-evaluated. Where a trial is running or comparison material is prepared, entry in the new catalogue justifies re-examining the route. Three costs belong in one calculation: sunk trial cost, the cost of preparing comparison material, and the schedule effect of switching. A trial past half enrolment rarely justifies a switch.

Exit risk comes from changes to the product. An entry corresponds to a particular description and intended use, so a substantive change in material, structure, intended use or method of use may take the product outside it. Under Article 79 of Order 47, a substantive change needs a variation registration and other changes must be filed within 30 days. Adding an entry-correspondence line to the change assessment form is the practical control.

Products outside the catalogue have two lawful exits. Article 25 of Decree 739 sets comparison and trial as parallel routes, so the question is whether a suitable same-variety product exists and whether its data can lawfully and sufficiently be cited. Article 17 of Order 47 requires Chinese material with translations and a licence for unpublished literature, making data availability a threshold in itself.

Device and IVD catalogues cannot be borrowed across. IVDs follow Order 48, as Article 121 of Order 47 confirms, and the applicable list is the 2025 IVD catalogue of 24 June 2025, separate from Notice No. 19 of 2025. Cross-referencing creates a structural mismatch, since the evidence required under a device entry differs from what an IVD exemption needs.

4. Practical recommendations

• Use the text of Notice No. 19 of 2025 as the only comparison baseline. Do not rely on an earlier edition or a third-party compilation for entry numbers or descriptions.
• Keep a four-column comparison record covering catalogue text, product content, agreement and basis, signed by registration and quality.
• Move difference evidence earlier. Start identifying differences as soon as entry is confirmed rather than at compilation, so the one-year correction window under Article 41 is not approached.
• Put catalogue correspondence into change control, with substantive changes routed to variation registration under Article 79.
• Handle IVDs against the IVD catalogue, using the 2025 list and the material format of Announcement No. 122 of 2021.
• Assess the comparison route first for unlisted products, running retrieval and data availability checks before committing to a trial.
• Re-check entry status periodically, since Article 34 allows the NMPA to adjust the catalogue and longer projects span revisions.

5. Verification checklist

• □ The text of the 2025 catalogue (Notice No. 19 of 2025, 12 May 2025) is held and confirmed as current.
• □ The relevant entry number is recorded, with description and intended use compared sentence by sentence.
• □ Cases of similar name but mismatched entry have been checked and reasoned.
• □ The four-column comparison table is complete and signed.
• □ Comparison material covers materials, structure, key performance, intended use and method of use.
• □ The same-variety data analysis reaches a conclusion rather than listing references.
• □ Each difference maps to traceable evidence (clinical literature, post-market data or non-clinical data).
• □ Unpublished literature is covered by a licence, and foreign material carries a Chinese translation (Article 17).
• □ IVDs have been judged against the 2025 IVD catalogue, not the device catalogue.
• □ Change control includes an entry-correspondence question.
• □ Unlisted products have documented retrieval and data availability checks.
• □ The response plan follows the one-year limit (Article 41), and fees follow the current NMPA catalogue with Class II verified provincially.

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