Registration Unit Division: The Upfront Decision That Sets Cost and Timeline

1. Key takeaways

Registration unit division is decided before submission yet sets the cost structure of the whole application. It acts on three lines.

• Fees. Class II fees are charged per unit, and public sources show CNY 40,670 per unit for a first Class II registration in some provinces (practical estimate; verify locally).
• Testing. Each unit needs a typical model, and its coverage sets the testing and sample workload.
• Documents. Technical requirements, instructions and labels, and clinical evaluation are organised per unit.

Four dimensions must align before models can share a unit: technical principle, structural composition, performance indicators, scope of application.

The GRZAN view. Both errors cost money, but differently. Merging too broadly is rejected at technical review, losing work already done and time. Splitting too finely triggers no correction and loses fees and testing effort silently, which is more insidious. Score the four dimensions before deciding, not the product line.

2. Legal basis

Administrative regulation. State Council Order No. 739 (9 February 2021; effective 1 June 2021): Article 6 (risk assessment considers intended purpose, structure and method of use), 14 (submission includes risk analysis, technical requirements, test report, clinical evaluation, draft instructions and quality system documents), 21 (a substantial change in design, materials, process, scope or use requires a variation), 22(1) (certificate valid 5 years; renewal 6 months before expiry), 23(1) (a novel device outside the catalogue is registered as Class III directly or classified and confirmed with the NMPA), 23(2) (confirmation within 20 working days of acceptance).

Departmental rules. SAMR Order No. 47 (26 August 2021; effective 1 October 2021): Article 6 (provincial approval of domestic Class II and system audits for domestic Classes II and III), 20 (classification rules and catalogue), 26 (objectively judgeable indicators and methods), 27 (instructions and labels), 30 (testing first), 31 (test products represent the applied product), 32 (self-test or qualified institute), 36 (clinical evaluation by same-variety data or trial), 41 (all defects at once; supplement within one year or refusal), 79 (variation). SAMR Order No. 53 (10 March 2022; effective 1 May 2022): Article 13 (licence within 20 working days, certificate within 10 working days, verification combinable with the registration audit). Former CFDA Order No. 6 (30 July 2014; effective 1 October 2014): Article 8 (generic name; Classes II and III matching the certificate).

Normative documents. Announcement No. 121 of 2021 (29 September 2021; effective 1 January 2022) sets submission content and formats; Notice No. 19 of 2025 (12 May 2025) lists clinical evaluation exemptions covering 1,047 items, 28 new; Announcement No. 126 of 2021 (21 October 2021) governs self-testing; Announcement No. 63 of 2025 (27 June 2025) sets clearer review requirements for robots, high-end imaging, artificial intelligence and new biomaterials; the NMPA fee catalogue sets domestic Class III first registration at CNY 153,600, variation 50,400, renewal 40,800, imported Class II first 210,900 and imported Class III first 308,800.

Practical estimate. No NMPA rule divides units across categories; the division follows each category’s review requirements and the catalogue, and the four dimensions are practice. Class II fees are set provincially, so verify at initiation.

3. Expert insights

The unit is a cost meter, and not only for fees.

The columns pull opposite ways: more units add certain cost, over-merging adds uncertain risk, and only the first can be budgeted. GRZAN converts uncertainty into expected cost; above a one-in-three chance of a forced split, merging usually costs more.

Judging the four dimensions. Technical principle: all models share one mechanism, so a different mechanism splits even where appearance and use are close. Structure: different main components split; accessories, options and appearance may differ if the requirements state it. Performance: materially different key indicators split; the same indicators at different ranges usually merge. Scope: a different purpose, population, site or environment splits, and scope shares facts with classification, so a change often changes the class. All four must align; any inconsistency means a split, the most conservative reading and the hardest to overturn.

The typical model is the last gate. A merge stands only if the test product represents the applied product (Article 31). Choose the most complex structure, the strictest key performance at its limit, and the widest function set. Where one model cannot cover all key performance, add models, which offsets the saving. GRZAN lists every model’s performance matrix, then marks the smallest set covering the extremes: the real testing workload.

Over-merging resets the timetable. Review orders a split, which costs more than paper: models are reselected and testing may be added; split units enter review separately, breaking the sequence; the correction clock starts, with the supplement due within one year (Article 41) or refusal; and the fee base changes, since some provinces charge CNY 40,670 per unit (practical estimate). The clock is the hardest constraint: the whole split must finish inside it.

Over-splitting is never flagged. It breaches no article, so nothing corrects it; the cost stays internal.

The fourth is overlooked: a certificate runs 5 years with renewal 6 months before expiry (Article 22(1)), so holding 10 certificates rather than 4 changes annual renewal work, invisibly at filing time.

Units, classification and variations move together. A unit must sit in one catalogue entry (Article 20), so a cross-entry merge is a classification question, resolved first. The division also fixes later changes: a new model consistent on all four dimensions is handled by change filing or reporting; one inconsistent on any dimension needs a separate application; an expanded scope that is substantial under Article 21 needs a variation. The second is the frequent error.

4. Practical recommendations

• Score the four dimensions in writing. Record a conclusion for each and file it.
• Fix the division before sampling. Typical model selection depends on it, or representativeness fails (Article 31).
• Select models from the performance matrix. Circle the smallest set covering the extremes and test it.
• Cost by unit, and verify locally. Class III first registration is CNY 153,600; Class II follows the provincial standard (some provinces CNY 40,670 per unit).
• Estimate the split probability. For borderline dimensions, convert the risk into expected cost first.
• Resolve classification first. Apply for confirmation under Article 23 (20 working days), then set the unit.
• Feed the division into model management. Consistent on all four dimensions means change filing; inconsistent means a new application.
• Keep renewal entries per certificate. Plan the 5-year cycle and 6-month window around the unit count.

5. Verification checklist

• □ Technical principle judged model by model; one mechanism throughout.
• □ Structure judged; main components identical, accessories and appearance may differ.
• □ Performance judged; key indicators consistent, range and size differences recorded.
• □ Scope judged; purpose, population, site and environment consistent.
• □ Unit within a single catalogue entry (Article 20).
• □ Cross-entry products confirmed under Article 23 (20 working days).
• □ Typical model chosen on complexity, strictest performance, highest risk (Article 31).
• □ Performance matrix built and the smallest covering set fixed.
• □ Division conclusion archived for sampling and drafting.
• □ Fees costed per unit: Class III CNY 153,600; Class II verified locally.
• □ Over-merge risk assessed with expected cost for borderline cases.
• □ Documents organised per unit, not mixed.
• □ Post-market model comparison process in place.
• □ Renewal register per certificate, 6-month window logged.

Verified as at 29 October 2026 against NMPA, SAMR and State Council publications; practical estimates have no legal effect.

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 National Medical Products Administration (NMPA) registrations, coordinates type testing at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com