Since the implementation of the Measures for the Administration of Medical Device Instruction Manuals and Labels (NMPA Order No. 6, effective October 1, 2014), Chinese labeling requirements have become stricter for all imported medical devices, including Class I devices. As of 2026, with the full adoption of the Unique Device Identification (UDI) system and intensified customs inspections, ensuring label compliance is more critical than ever. Non‑compliant labels are a leading cause of shipment delays, product detention, and even fines. This guide consolidates the latest labeling rules applicable to imported Class I devices, explains mandatory content, and provides practical steps to achieve full compliance.
1. Legal Basis and Applicable Standards
The primary regulation governing medical device labeling in China is NMPA Order No. 6 – Measures for the Administration of Medical Device Instruction Manuals and Labels (revised 2014, still fully in effect). Under this regulation, all medical devices sold or imported into China must have a Chinese instruction manual and a Chinese label that conforms to the requirements. For Class I devices, the label must be present on the smallest sales package and, if applicable, on the device itself. Additional requirements stem from:
- Medical Device Supervision and Administration Regulation (State Council Decree No. 739, 2021) – Articles 38–40 outline labeling and traceability obligations.
- Regulations on the Administration of Medical Device Unique Identification System (UDI) – Implemented in phases; full implementation for all Class I devices began June 1, 2024 (after a transition period). As of 2026, all imported Class I devices must bear a UDI barcode.
- GB/T 191-2008 – Packaging pictorial markings for storage and transport (e.g., “keep dry”, “temperature limit”).
- Product‑specific standards – For example, labeling of sterile devices must indicate “sterile” and the sterilization method.
Importers must ensure that labels comply with all applicable national standards and that the Chinese agent’s information is correctly presented.
2. Mandatory Content on Class I Device Labels
Under Order No. 6, Article 10, the label of a medical device must include the following elements. For imported Class I devices, each element must be in simplified Chinese (foreign languages may appear in addition but must not be more prominent).
- Product name – Must exactly match the name approved in the Class I medical device filing certificate (备案凭证). No abbreviation or alteration.
- Model, specification – As declared in the filing dossier.
- Name and address of the registrant/filer – For imported devices, this is the overseas manufacturer’s name and address (in Chinese or with Chinese translation).
- Name and address of the China agent – The local responsible party (agent) that holds the filing certificate. Contact information (phone number) is strongly recommended.
- Production date – Must be in YYYY‑MM‑DD format or “YYYY年MM月DD日”.
- Use‑by date or shelf life – Clearly marked as “失效日期” (expiry date) or “使用期限”. For devices with a limited lifespan (e.g., sterile single‑use devices), the expiry date must be given.
- Storage and handling conditions – E.g., “Store in a cool, dry place away from light.”
- ”For single use only” or similar restrictions – If applicable.
- “Sterile” and method of sterilization – For sterile devices.
- Unique Device Identification (UDI) barcode – As required by UDI implementation schedule (see Section 4).
- “See instruction manual” for certain warnings – If label space is limited, a statement “详见说明书” (see instruction manual for details) may be used, but critical warnings must still be on the label.
In addition, Article 11 requires that if the label cannot contain all the above information due to size constraints, the information may be provided in the instruction manual, but the label must still include product name, model, production date, expiry date, and “see instruction manual”.
3. Language and Translation Requirements
All text on the label must be in simplified Chinese. If a foreign language (e.g., English) appears on the original packaging, the Chinese text must be at least as prominent. Common mistakes include:
- Using machine‑translated terms for technical specifications (e.g., “sterile” incorrectly translated).
- Omitting the Chinese translation of the manufacturer’s address – the address must be fully translated, not just the name.
- Placing the Chinese label on a removable sticker that is easily peeled off. The label must be permanent (e.g., printed directly or affixed with strong adhesive).
How to comply: Use a professional translator with medical device terminology experience. Have the translation reviewed by a local regulatory agent. Ensure the label is printed on the packaging or affixed with a durable sticker that cannot be removed without damage.
4. Unique Device Identification (UDI) Requirements for Class I Devices
China has been implementing the UDI system in phases. According to the Announcement on Carrying out the Unique Device Identification System (NMPA Announcement No. 72 of 2019), the rollout schedule was:
- Class III devices: Mandatory from January 1, 2021.
- Class II devices: Mandatory from June 1, 2022.
- Class I devices: Mandatory from June 1, 2024 (after a transition period).
As of 2026, all imported Class I devices must bear a UDI barcode on the label. The UDI must comply with the UDI Implementation Rules and include both the device identifier (DI) and production identifier (PI). The DI must match the product information in the NMPA filing database. For Class I devices imported in small quantities, the UDI may be applied as a 1D (GS1-128) or 2D (Data Matrix) barcode.
How to comply: Work with a GS1 China authorized barcode provider to obtain DI codes. Apply the UDI barcode legibly on the label; test the barcode readability with standard scanners. Update the UDI information in the NMPA UDI database (China NMPA UDI platform).
5. Special Labeling Considerations for Sterile Class I Devices
If your Class I device is supplied sterile (e.g., sterile drapes, examination gloves, certain single‑use instruments), additional labeling requirements apply under Order No. 6 and GB 18279 (EO sterilization) or GB 18280 (radiation sterilization). The label must:
- State “STERILE” (无菌) prominently.
- Indicate the sterilization method (e.g., “Ethylene oxide sterilization”, “Gamma irradiation”).
- Display the expiry date (失效日期) after sterilization.
- If the device is for single use only, clearly mark “单次使用” (single use) and include a symbol (if any).
For sterile devices that are also Class I, the label must not contain any claims of biocompatibility or clinical performance beyond what is allowed in the filing dossier.
6. Role of the Chinese Agent in Label Compliance
For imported devices, the China agent (also called the “responsible party” or “filing holder”) bears responsibility for ensuring that the label meets all Chinese requirements. The agent’s name and address must appear on the label exactly as registered in the NMPA filing certificate. Many rejections occur because the agent’s information is outdated or misspelled.
Agents should maintain a master label file for each imported product, review artwork before production, and retain copies of approved labels for at least 5 years. Customs may request the label file during inspection.
7. Common Labeling Mistakes and How to Correct Them
Based on actual customs detentions, the most frequent labeling errors for imported Class I devices include:
- Missing filing certificate number – The number must be printed on the label. Without it, the shipment will be detained.
- Incorrect date format – Using “MM/DD/YYYY” instead of “YYYY‑MM‑DD”.
- No UDI barcode – Class I devices imported after June 1, 2024 must have UDI; missing barcode leads to rejection.
- Using an obsolete agent address – When the agent’s office moves, the label must be updated.
- No Chinese for storage conditions – Symbols alone are insufficient; Chinese text is required.
- Prohibited statements – “Non‑sterile” not allowed if product is sterile; claims like “hospital grade” may be considered misleading if not substantiated.
How to fix: For each correction, create a new artwork proof and submit it to the agent for verification. If labels have already been printed, you may apply a permanent sticker with the corrected information (provided the sticker does not cover essential safety information). However, customs may still reject stickers that appear temporary. Best practice is to reprint compliant labels.
8. Pre‑Import Label Verification Checklist
Before shipping any Class I device to China, use this checklist to verify label compliance:
- [ ] Product name matches filing certificate exactly.
- [ ] Model and specification as declared.
- [ ] Manufacturer‘s name and address (overseas) in Chinese translation.
- [ ] China agent’s name and address as registered.
- [ ] Filing certificate number (格式: X械备XXXXXX号).
- [ ] Production date in YYYY‑MM‑DD format.
- [ ] Expiry date (if applicable) clearly marked.
- [ ] Storage conditions in Chinese (not just symbols).
- [ ] UDI barcode (GS1 format) present and scannable.
- [ ] For sterile devices: “STERILE” and sterilization method indicated.
- [ ] All text in simplified Chinese, no machine translation errors.
- [ ] Label is permanent (printed or high‑quality adhesive).
Summary: Updated Chinese labeling rules for imported Class I devices require strict compliance with NMPA Order No. 6, including mandatory Chinese text, filing certificate number, UDI barcode, and correct agent information. Common mistakes such as missing UDI, incorrect date formats, or incomplete translations can be avoided by using a professional translator, engaging a qualified China agent, and following the pre‑import verification checklist. With full UDI implementation effective since June 2024, all Class I devices must now bear a scannable barcode. Proactive label management ensures smooth customs clearance, reduced costs, and uninterrupted market access for your medical device products.