Chinese labelling for foreign manufacturer (medical device and IVD)

Key Regulatory References

 


Core Elements of Chinese IFU

According to Article 10, an IFU should cover:

  • Product details (name, model, specification, certificate number)
  • Registrant/manufacturer information (address, license numbers, contacts, Chinese agent for imports)
  • Technical requirements (performance, structure, intended use)
  • Safety details (contraindications, precautions, warnings)
  • Instructions for use, repair, maintenance, storage, and transport
  • Accessories list and replacement guidance
  • Manufacturing/production date, shelf life or expiry date
  • Explanation of symbols/abbreviations
  • Revision history

 


Core Elements of Chinese Label

As per Article 13, the label must include:

  • Product identification (name, model, specification)
  • Registrant and agent details (for imported devices)
  • Manufacturer and production details
  • Certificate/filing number
  • Production date, shelf life/expiry date
  • Power conditions (for active devices)
  • Symbols, warnings, storage/operational conditions
  • Environmental or radiation hazard warnings (if applicable)

If the label is too small, at minimum it must display:

  • Product name, model, specification
  • Production date, service life/expiry date
  • Statement: “Refer to instructions for other details”

 


Changes to Labels and IFUs

  • Critical changes (e.g., intended use, technical requirements, service life) → trigger full re-registration
  • Non-critical IFU updates for Class II/III → only special IFU change registration (≈20 working days review)

 


Home Country vs. Chinese Labels

Two approaches are common:

  1. Use only Chinese label that fully meets NMPA requirements
  2. Use both home country and Chinese label in parallel

Manufacturers often prefer dual labelling to show product origin, but content conflicts must be avoided.

 


Matrix of Chinese Labelling

Below is a simplified mapping of required elements across Chinese Label, Chinese IFU, and Product Certificate:

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Item Chinese label Chinese IFU
Product certificate Certification number
Name and address of legal manufacturer
Name and address of Chinese agent
Product name, model name, variant		 Certification number
Name and address of legal manufacturer
Address of production
Name and address of Chinese agent
Product name, model name, variant
Composition
Intended use
Product technical requirement (annex of product certificate) Product name, model name, variant Product name, model name, variant, specification, material
Type testing (testing report) e.g. Power connection conditions and input power Specification tested in type testing.
e.g. EMC table with Chinese requirement
Chapter 2 Device description Product name, model name, variant
Composition
Intended use		 Product name, model name, variant
Composition
Intended use
Chapter 3 V&V Shelf life Specification of all critical V&V output: shelf life, transport condition, reuse times of single use, packaging material, sterilisation method, software
Chapter 6 Production Address of production Address of production

Customer Checks of Chinese Labelling in China


In addition to regulatory inspections, customers and distributors in China often verify labelling compliance themselves before accepting products. Typical checks include:

·        Confirming the Chinese agent’s name and contact details are correctly listed

·        Ensuring symbols and safety warnings follow Chinese GB/YY standards

·        Comparing expiry dates and batch numbers between the product, IFU, and packaging

·        Checking that dual labels (home country + Chinese) do not conflict

·        Verifying that translations are accurate and free from ambiguity

Failure in these checks may result in delays, rejected shipments, or reputational risk in the Chinese market.


How We Can Support You


Whether you are a regulatory affairs specialist, a product manager at a manufacturing company, or a stakeholder in the supply chain (including translation offices), we can help you streamline and strengthen your Chinese labelling process.

Our support includes:

  • Chinese labelling procedures – step-by-step guidance to ensure compliance with NMPA requirements.
  • Change assessment of labelling – evaluating whether modifications trigger re-registration or simplified IFU updates.
  • IFU matrix with PTR and TD – mapping Instructions for Use against Product Technical Requirements (PTR) and Technical Documentation (TD) to secure alignment and regulatory readiness.
  • AI-powered IFU check tool – quickly reviews Chinese IFUs for completeness, terminology consistency, and compliance gaps, reducing human error and saving time.



With our expertise, you can achieve lean, compliant, and consistent labelling for the Chinese market.