China Medical Device Registration Dossier Format: Announcement No. 121 of 2021

1. Key takeaways

Announcement No. 121 of 2021 (NMPA) took effect on 1 January 2022 and works alongside the Medical Device Registration and Filing Measures (SAMR Order No. 47, effective 1 October 2021). It converts the seven categories in Article 14 of the Regulation on the Supervision and Administration of Medical Devices into an item-by-item dossier catalogue and unifies the approval certificate format.

• The dossier requirements govern what is submitted and how deeply; the certificate format governs what is approved and how the certificate reads.
• Article 41 of Order No. 47 governs corrections: all deficiencies notified at once, everything submitted once within one year, otherwise review terminates with a refusal.
• Article 17 requires Chinese materials, translations with originals and a licence for unpublished literature; Article 18 covers origin-country marketing evidence in three tiers.
• Certificates are electronic with the same legal effect as paper under Article 117; validity is five years and renewal is filed six months before expiry.
• GRZAN’s assessment: formal defects cause more first-time returns than companies expect yet cost least to fix. A dedicated pre-submission review of catalogue completeness, signatures, translations and versions is the highest-yield action.

2. Legal basis

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

• Article 13: Class I filed, Classes II and III registered; the holder or filer answers for life-cycle quality.
• Article 14: seven categories, namely risk analysis, technical requirements, test report, clinical evaluation, instructions and label drafts, quality system documents, and other materials; the test report may be a self-test or one from a qualified testing institution.
• Article 17(2): forwarded to technical review within three working days of acceptance. Article 18(1): decision within twenty working days of the review opinion. Article 22: five-year term, renewal filed six months before expiry.

Departmental rule. Order No. 47 adds:

• Article 8: domestic Class I at municipal level, Class II provincial, Class III at NMPA; imported Class I filed with NMPA, imported Classes II and III registered with NMPA.
• Article 14(2): overseas applicants appoint a Chinese domestic enterprise legal person as agent.
• Article 17: Chinese materials, translations with originals, licence documents for unpublished literature.
• Article 18: origin-country evidence in three tiers, for products marketed abroad, products not regulated as devices at origin, and innovative devices not yet marketed overseas.
• Article 19: applicable mandatory standards met; where inapplicable, an explanation and supporting materials submitted.
• Article 26: the applicant states functional and safety specifications and test methods that can be objectively determined on the finished product.
• Article 30: testing against the technical requirements must pass before trials or before applying.
• Article 41: deficiencies notified in full, answered once within one year, failing which review terminates with a refusal.
• Article 79: substantive changes to variation registration, other changes filed within thirty days, certificate items to variation and holder or agent names and addresses to filing.
• Articles 117, 120 and 121: electronic licences equal to paper, fees per the finance and pricing authorities, IVDs under the separate IVD measures.

Normative documents. Announcement No. 121 (published 29 September 2021, effective 1 January 2022) sets the catalogue and certificate format; No. 122 does the same for IVDs. No. 126 of 2021 governs self-testing, with the inspection guide of 16 September 2025. The QMS inspection guide (notice No. 50 of 2022) defines four outcomes. Announcement No. 63 of 2025, Part Four, clarifies review requirements further.

Fees. Domestic Class III initial registration RMB 153,600, variation RMB 50,400, renewal RMB 40,800; imported Class II initial RMB 210,900 and Class III RMB 308,800; innovative applications from small and micro enterprises are exempt. Domestic Class II fees are provincial, some schedules showing RMB 40,670 per registration unit, to be verified locally at inception.

Practical estimate: numbering, pagination, bookmark and stamping conventions follow current acceptance requirements and system rules; departments differ on binding items.

3. Expert insights

Catalogue, not a lower standard. Article 14 is a compressed frame; Announcement No. 121 breaks its seven categories into tickable items so applicant, acceptance department and reviewer share one coordinate system. A dossier becomes a form plus evidence, so the question shifts from sufficiency to whether each item carries evidence corroborating across files. A risk control measure should appear as an objectively determinable specification, a corresponding test result and a corresponding warning. A mismatch anywhere triggers correction.

Formal and substantive defects differ in cost. Article 41 treats both alike procedurally; the difference is the repair radius.

GRZAN’s view: cutting formal defects near zero offers the best return without technical breakthrough.

Consistency fails more often than completeness. The common weakness is the same fact written differently. Four places drift: product name, which must match across requirements, instructions, labels and clinical evaluation, and for Classes II and III must match the certificate under Article 8 of the Provisions on Instructions and Labels; the model and specification list, which must share one source; structural composition and intended use, which must corroborate across three files; and cited standard editions, whose year designations must be current.

Imported files carry two extra links. Beyond the general requirements sit the subject qualification chain — the Chinese legal person appointed under Article 14(2) plus the agent’s assistance with Article 20(1) duties — and the origin-country evidence in three tiers under Article 18. The sequence is subject first, catalogue second. A frequent failure is an authorisation, notarisation or legalisation dated later than the documents it supports, leaving the timeline incoherent; complete both chains before drafting.

The certificate connects to later obligations. Certificate items fall within variation, while holder and agent names and addresses fall within filing under Article 79, so every field can become a trigger. Three handovers matter: renewal six months before the five-year expiry; substantive changes to variation and others to filing within thirty days; and electronic licences usable directly for tendering and platform onboarding.

Direction set by Announcement No. 63 of 2025. Part Four points toward published, specified expectations. Search existing review points, guidelines and published reports at route-design stage and build them into the protocol; for new questions, seek confirmation through Article 22 communication and Article 23 expert consultation rather than testing through correction.

4. Practical recommendations

• Build an item-level ledger with owner, source document, version and status, closing each line before submission.
• Add a formal compliance review by staff who did not draft the file.
• Compare name, models, structure, intended use and standard editions across all files.
• Audit dates so authorisations, notarisation, test and study reports run in sequence.
• For imports, finish the agent and origin-country chains before drafting.
• Answer correction notices in one submission within the one-year window.
• Track certificate and filing items separately with change triggers.
• Verify fee levels at inception, including the provincial Class II standard.

5. Verification checklist

• □ Dossier prepared against the No. 121 catalogue, without gaps or extras?
• □ All seven categories present, from risk analysis to quality system documents?
• □ Chinese throughout, translations with originals, licences for unpublished literature?
• □ Product name, models, structure and intended use identical across all files?
• □ Cited mandatory and recommended standards current?
• □ Test report from an eligible body; self-tests meeting Announcement No. 126?
• □ For imports, agent appointed and origin-country evidence handled in three tiers?
• □ Authorisation, notarisation, test and study dates coherent?
• □ Signatures, pagination and version markings meeting current rules?
• □ Correction notice answered in full within one year?
• □ Certificate and filing items in a change ledger?
• □ Five-year term and six-month renewal milestone scheduled?
• □ Archived copy of the submitted version retained for later comparison?

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