China IVD Registration: Order No. 48 and the Separate Reagent Track

1. Key takeaways

In vitro diagnostic reagents follow a separate departmental rule, the Measures for the Registration and Filing of In Vitro Diagnostic Reagents (SAMR Order No. 48, published 26 August 2021, effective 1 October 2021), not the Medical Device Registration and Filing Measures (Order No. 47, published and effective on the same dates). The connecting provision is Article 121 of Order No. 47.

• Dossier format has its own announcement: No. 122 of 2021 (published 29 September 2021, effective 1 January 2022), on the same dates as No. 121.
• Clinical terminology runs on two tracks: devices are exempt from clinical evaluation (notice No. 19 of 2025, published 12 May 2025), IVDs exempt from clinical trials (IVD catalogue 2025, 24 June 2025). The terms are not interchangeable.
• Evidence structure differs: devices follow a product to human line; IVDs run analytical then clinical performance, the first being the precondition.
• Post-market requirements overlap: the Production Quality Management Practices (No. 107 of 2025, effective 1 November 2026, fifteen chapters and 132 articles) also covers IVD manufacture, and the second UDI batch (No. 114 of 2021) includes IVDs.
• GRZAN’s assessment: companies spanning both categories most often fail by borrowing templates; the two rules are parallel and templates cannot be shared.

2. Legal basis

Administrative regulation. The Regulation (State Council Order No. 739, published 9 February 2021, effective 1 June 2021) provides:

• Article 6: risk-based classification. Article 13: Class I filed, Classes II and III registered, with life-cycle responsibility on the holder.
• Article 14: seven categories of materials; the test report may be a self-test or from a qualified institution.
• Article 16: domestic Class II to the provincial regulator, Class III to NMPA. Articles 24 and 25: two exemptions and two clinical evaluation routes.

Departmental rules. Order No. 48 is the dedicated rule, applied in parallel with Order No. 47, which supplies:

• Article 5: CMDE reviews domestic Class III and imported Class II and III applications, variations and renewals.
• Article 8: Class I at municipal level, domestic Class II provincial, domestic Class III and imported Classes II and III at NMPA.
• Article 17: Chinese materials, translations with originals, licences for unpublished literature. Article 19: mandatory standards met or inapplicability explained.
• Article 28: the nine non-clinical study types. Article 29: method validation, plus statistical method, sample size basis and criteria where statistics apply.
• Articles 30 and 31: testing must pass before trials or application; samples must represent the product applied for.
• Article 41: deficiencies notified once, answered within one year, otherwise review terminates with a refusal. Article 79: substantive changes to variation, others filed within thirty days.
• Articles 120 and 121: fees per the finance and pricing authorities; IVDs follow the IVD measures.

The Production Supervision Measures (Order No. 53, published 10 March 2022, effective 1 May 2022) require a licence decision within twenty working days and issue within ten, with inspection possibly combined with registration inspection, and renewal between ninety and thirty working days before expiry. The Provisions (former CFDA Order No. 6) require accurate content consistent with the registration, Chinese text and no unauthorised change.

Normative documents. Announcement No. 122 covers the IVD dossier and certificate format; No. 121 applies to devices on the same dates. The IVD exemption catalogue was published on 24 June 2025; the device catalogue (notice No. 19 of 2025) covers 1,047 products with 28 additions and 25 revised descriptions. Announcement No. 114 sets the second UDI batch as remaining Class III devices including IVDs, down to the secondary product category. The Practices add chapters on quality assurance, validation and confirmation, and contract manufacturing.

Practical estimate: classification, naming, unit division, the depth expected for analytical and clinical performance, and the rules for filing reagents with instruments, calibrators and controls rest mainly on Order No. 48 and current guidance. This article does not expand Order No. 48 clause by clause.

3. Expert insights

Two rules in parallel. Article 121 assigns IVDs to the IVD measures by design.

Both rules share the dates 26 August 2021 and 1 October 2021; both announcements share 29 September 2021 and 1 January 2022. The symmetry shows parallel rules, not a hierarchy: Order No. 48 is dedicated, not an implementing detail. Device templates therefore cannot serve IVD filings, and mixing causes rework after review begins.

Two terminologies.

The terminology reflects the evidence structure. For devices the exemption covers the whole evaluation of benefit against risk; for IVDs it covers the trial element linking result to clinical status, leaving analytical performance and the rest of the evaluation in place. Reading catalogue entry as no clinical work is a common misjudgement: entry still requires consistency with the description and evidence for differences.

Two-stage evidence.

For IVDs the depth of analytical work decides whether clinical evaluation is accepted. Sample size, interference lists, hook effect, cross-reactivity and lot variation, if unresolved here, pass into clinical evaluation and cannot be cured by adding samples. Article 29 applies to analytical studies too.

The combination adds a decision dimension. An IVD filing usually covers a system of reagent, instrument, calibrator and control, raising two structural decisions: where the combination boundary lies, meaning what enters the unit and what is filed separately; and how traceability, matching and consistency across the four are shown. Once drawn, every change is assessed against the boundary, and without traceability the analytical data lack a supporting chain.

Unit and name before documents. One methodology may cover several analytes, one analyte may suit several methodologies, and one reagent may fit several instruments. The order is classification and naming, then unit division, then documents. Reversing it forces studies and evaluation to be redone.

Post-market overlaps. Order No. 48 is dedicated but does not detach IVDs from the general framework. Manufacture falls under the Practices effective 1 November 2026; UDI applies, since the second batch includes IVDs down to the secondary product category; and Article 79 of Order No. 47 remains the coordinate for change management, subject to the current text of Order No. 48.

4. Practical recommendations

• Decide at inception whether Order No. 48 or No. 47 applies, then choose No. 122 or No. 121 as the catalogue basis.
• Use the terminology of the correct track consistently.
• Treat catalogue entry as a documentation obligation with consistency and difference evidence.
• Complete analytical performance before clinical evaluation.
• Fix method validation, sample size basis and criteria in the protocol (Article 29).
• Define the combination boundary before drafting, with traceability argued.
• Confirm classification, naming and unit division first.
• Prepare for the Practices before 1 November 2026 and confirm UDI scope.

5. Verification checklist

• □ Order No. 48 confirmed, Article 121 as the basis?
• □ Dossier under No. 122, not the No. 121 template?
• □ Terminology consistent with the track?
• □ Where exemption applies, consistency with the 2025 IVD catalogue checked?
• □ Analytical performance covers the required items, method validation complete?
• □ Where statistics apply, method, sample size and criteria specified?
• □ Testing passed (Article 30)?
• □ Test samples representative (Article 31)?
• □ Combination boundary set, traceability demonstrated?
• □ Classification, naming, unit division completed before drafting?
• □ Chinese materials with originals; standards met or explained?
• □ Production aligned to the 2026 Practices by 1 November 2026?
• □ UDI scope confirmed, second batch includes IVDs?
• □ Change ledger kept, decisions recorded?

Regulatory information verified as at 29 October 2026. Legal texts follow the versions published by NMPA, SAMR and gov.cn and must be rechecked after amendment or repeal. Time limits, fees and catalogue scope reflect the official position on that date; content marked practical estimate has 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 prepares NMPA-compliant dossiers, coordinates typetesting and clinical evaluation documents, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com