Clinical Evaluation Pathways for NMPA Device Registration

1. Key takeaways

Three clinical evaluation routes exist, and they are applied in a fixed order rather than selected by cost.

• The routes form a mandatory funnel, not a parallel menu. Test the exemption first, same-variety comparison second, a clinical trial last. Skipping a step is a pathway error.
• Exemption from clinical evaluation is not exemption from clinical material. Article 36 of Order 47 (promulgated 26 August 2021, effective 1 October 2021) still requires a comparison table, an analysis of same-variety clinical data and scientific evidence for differences.
• The comparison route turns on whether differences can be covered by scientific evidence; a missed difference is the most common cause of a deficiency notice.
• Trials cost most but do not carry the lowest review risk. Protocol design, site qualification, ethics review and process records each fail in technical review and again in project inspection.
• A wrong pathway has a measurable price. Under Article 41 deficiencies are notified in full at one time and must be answered within one year, failing which review is terminated without approval.
• The sequence cannot be reversed. Article 30 requires a product to pass testing against its technical requirements before a trial starts or an application is filed.

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 material, the fourth being clinical evaluation; test reports may be self-issued or from a qualified institution.
• 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.
• Article 26: clinical trial sites are subject to filing, and the sponsor shall file.
• Article 28: ethics review and informed consent; no trial-related fee may be charged to subjects.

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

• Article 30: testing against the product technical requirements; only a passing product may enter a trial or be filed or registered.
• Article 31: the tested product must be representative.
• Article 33: principles of clinical evaluation.
• Article 34: the two exemption situations and the body that formulates the catalogue; Article 35: clinical evaluation guidelines.
• Article 36: the material required under each route.
• Article 37: site filing and sponsor filing.
• Article 41: deficiencies notified in full at one time, answered within one year, otherwise review is terminated and approval refused.

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 new, 25 product descriptions revised.
• Good Clinical Practice for Medical Device Trials (NMPA Announcement No. 28 of 2022, published 24 March 2022, effective 1 May 2022): nine chapters, 66 articles.
• Announcement on Registration Application Materials and Approval Document Format (NMPA Announcement No. 121 of 2021, published 29 September 2021, effective 1 January 2022).
• Fees: under the NMPA licensing fee catalogue, a high-risk device trial application costs RMB 43,200 and a domestic Class III initial registration RMB 153,600; innovative devices from small and micro enterprises are exempt.

Practical estimate. No unified official figure exists for drafting time, retrieval cost or provincial Class II fees. Some provinces publish RMB 40,670 per registration unit for Class II initial registration; the current rate must be verified with the provincial medical products administration and finance department at project initiation.

3. Expert insights

The routes are a decision sequence, not a cost ranking. The chain is fixed: exemption under Article 24 of the regulation and Article 34 of the order; evaluation with same-variety clinical data; a trial only where neither applies. What differs is the source of evidence, not the burden of proof.

Exemption from clinical evaluation and exemption from a trial are two layers. The first waives the evaluation activity under Article 24 of the regulation and Article 34 of the order; the second waives the data-generating activity. Confusing them leads a company to treat catalogue entry as no clinical work, produce a one-page model comparison and prepare no evidence for differences. Review issues a deficiency under Article 36 and the correction period is added to the schedule.

Same-variety comparison succeeds on the difference list, not the product list. GRZAN builds the difference list first and works back to the evidence. Five dimensions are covered: working principle and structure; materials and key components; performance and test methods; intended use and contraindications; method of use and environment. Each item is marked consistent, different or not determinable. Every difference must map to published literature, post-market data for the same variety, or non-clinical data under Article 28. Non-determinable items are the real risk, because the comparator is not truly the same variety or its data cannot be obtained; the answer is to change the comparator or move to a trial.

Trial compliance cost is spread over four stages, not concentrated in review. The Good Clinical Practice standard covers ethics, sites, investigators, sponsors, protocols, reports, multicentre arrangements and records in nine chapters and 66 articles.

Site filing and sponsor filing are parallel obligations before the trial starts (Article 26 of the regulation; Article 37 of the order); if either is missing, the data will struggle to be accepted.

Two prior decisions can force rework. First, technical requirements and testing: Articles 30 and 31 require a passing test on a representative sample, and an engineering prototype breaks the data chain. Second, registration unit division: models must share a technical principle and main performance indicators, otherwise the unit splits and each part repeats the route.

4. Practical recommendations

• Write a pathway memorandum first. One page stating whether an exemption applies and which catalogue item, the comparator and certificate number, the difference dimensions and the route, signed by registration, clinical and quality.
• Compare catalogue entries word by word. A similar name is not a matching entry; check structure and intended use against the 2025 notice.
• Build the five-dimension difference list and reject the phrase basically consistent. Each difference must map to evidence recorded in the list.
• Verify data availability before drafting. The comparator data must be published and lawfully citable; Article 17 requires a licence for unpublished studies.
• Complete both filings before recruitment under Article 26 of the regulation and Article 37 of the order.
• Schedule responses backwards from the one-year limit, tracking material, owner, source and expected days weekly.

5. Verification checklist

• □ The product was compared sentence by sentence against the 2025 catalogue entry.
• □ The pathway memorandum records one route from three, with reasons.
• □ The comparator name, certificate number and marketing status are recorded.
• □ The difference list covers five dimensions, each item judged consistent, different or not determinable.
• □ Every difference maps to traceable evidence; non-determinable items state reason and next step.
• □ Unpublished literature carries a rights holder licence (Article 17).
• □ Technical requirements are final, testing passed, sample representativeness justified (Articles 30 and 31).
• □ Site filing and sponsor filing are complete (Article 26; Article 37).
• □ Ethics approval matches the protocol; the consent form states no trial fee (Article 28).
• □ Registration unit division is fixed, with consistent technical principle across models.
• □ The response plan follows the one-year limit (Article 41); fees follow the current NMPA catalogue.

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