NMPA · East Asia & PacificEvery China dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Search official NMPA device registration records.
Search the official NMPA full UDI release by device identifier, product, model, labeler, or registration reference.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official NMPA regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current NMPA application, review, and renewal fees.
Estimate the likely NMPA pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent NMPA policy, guidance, and compliance updates.
Describe your device and get a preliminary NMPA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other China requirements.
Describe a device and find comparable products in the NMPA registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Common questions about changing a registered medical device in China. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 24 official sources · latest verification 2026-09-15
NMPA registration fees in CNY · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Imported Class I filing | CNY 0 | Verified |
| Imported Class II registration | CNY 210,900 | Verified |
| Imported Class II change registration (变更注册) | CNY 42,000 | Verified |
| Imported Class II renewal registration (延续注册) | CNY 40,800 | Verified |
National Medical Products Administration (NMPA) review clocks and planning ranges · 3-class (I, II, III) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class I(Filing/Recordation (备案) — no review, no fee) Zero days is the published position, not an estimate: the NMPA service item classifies the filing as an 即办件 and states that where the materials are complete and in the required form the filing is made 当场 — on the spot — against a sealed 备案凭证 Regulation No. 739 art. 15 completes the filing on submission of conforming materials and obliges the authority to publish the filing within 5 working days of receipt, which is a publication duty rather than a review period Deficient materials draw a single consolidated notice of everything needing correction, so the elapsed time in practice is dossier preparation under Announcement No. 62 of 2022, which is what the realistic range measures No fee, and no expiry; filed with the municipal authority for a domestic device and with NMPA for an imported one, through a designated Chinese legal person | 0 days | 2-4 months | Verified |
| Class II(Provincial Registration) Technical review 60 days under the parallel Order No. 47 Art. 92 structure; statutory administrative decision 20 working days; promised acceptance 5 working days In-country testing required (~6 months) Clinical often exempted | 4 months | 1-1.5 years | Verified |
| Class III(NMPA Registration) Class III technical review: 90 days for registration/change/renewal, 60 days after applicant supplement (Order No. 47 Art. 92); statutory administrative decision 20 working days; promised acceptance 5 working days IVD technical review (Order No. 48 Art. 92): Class II IVD 60 days, Class III IVD 90 days, plus supplement clocks Clinical trials often required In-country testing 6-9 months | 5-6 months | 2-3 years | Verified |
Newest official NMPA headlines from the daily-refreshed feed — every row links directly to the authority publication.
ChinaAug 21N/NMPA / National Institutes for Food and Drug Control (NIFDC)China NIFDC Notice on Surveying Implementation of Two Mandatory National Standards for Physical Therapy EquipmentChinaAug 15N/NMPA / National Institutes for Food and Drug Control (NIFDC)NMPA Announcement on Issuing 46 Medical Device Industry Standards Including 'Dentistry - Light Curing Units' (2026 No. 76)ChinaAug 14N/NMPA / National Institutes for Food and Drug Control (NIFDC)Notice on review meeting for national standard 'Sterilization of health care products – Moist heat – Development, validation and routine control of a sterilization process for medical devices'ChinaAug 5N/NMPA / National Institutes for Food and Drug Control (NIFDC)Notice on Convening the Review Meeting for 8 National Standards and Guidance Documents Including Antimicrobial Susceptibility Testing SpecificationsChinaOfficial NMPA rules and guidance · 5 of 5 documents linked to official sources
Computed from 137,840 official NMPA registration records · data as of 2026-09-18
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Structure company, product, model, approval, certificate, and evidence facts before starting China work.
Connect the NMPA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against NMPA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to NMPA evidence, notification, timing, and implementation questions.
Assess a current NMPA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for China (NMPA).
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