Chinese labelling and instructions for use, clause by clause

Labelling is usually the last thing an exporter thinks about and one of the first things a Chinese inspection looks at. The reason it goes wrong so reliably is a category error: the Chinese label and instructions for use are treated abroad as a translation exercise, and treated in China as part of the regulatory file. They have to agree with what was registered, and they have to carry a specific list of items. There is also a list of things they may not say — a list that reads, from a Western marketing department’s point of view, like a summary of its best work.

What follows is that requirement set as it stands in 《医疗器械说明书和标签管理规定》, the Provisions for the Administration of Medical Device Instructions for Use and Labels.

Regulatory basis

《医疗器械说明书和标签管理规定》 — Provisions for the Administration of Medical Device Instructions for Use and Labels, CFDA Order No. 6, adopted 27 June 2014, promulgated 30 July 2014 and in force from 1 October 2014, issued under the Regulations on the Supervision and Administration of Medical Devices. It replaced the 2004 provisions on instructions, labels and package markings (SFDA Order No. 10).

The regulations that govern everything below

Four principles run through the whole instrument, and most non-compliance is a breach of one of them rather than of a specific line item.

Consistency with the registration. The content must be scientific, true, complete and accurate, must match the characteristics of the product, and must agree with what was registered or record-filed. The label must in turn agree with the instructions for use. Three documents, one story.

Chinese governs. The text must be in Chinese and must conform to standard Chinese language usage. Other languages may be added — but where versions differ, the Chinese text prevails. A bilingual label is not an English label with a Chinese courtesy translation; the Chinese is the legally operative text and the English is the addition.

Standard vocabulary. Disease names, technical terms and descriptions of diagnostic or treatment processes and outcomes must use nationally issued or standardised terminology, and units of measurement must follow national standards. Symbols and identifying colours must follow the relevant national standards; where no standard exists for a symbol, the instructions must explain it.

The product name is not free text. It must be the generic name, formed under the naming rules for medical devices, and for Class II and Class III it must be identical to the product name on the registration certificate. It has to appear clearly and prominently on both the instructions and the label.

One more that is easy to miss: the instructions for use must accompany the smallest sales unit, not the shipping carton.

Instructions for use: the required checklist

• Product name, model and specification
• Registrant or filer name, address and contact details, plus after-sales service unit; for imported devices, also the agent’s name, address and contact details
• Manufacturer name, address, production address, contact details and production licence or filing number; for contract manufacturing, the same for the contracted manufacturer
• Registration certificate number or record-filing number
• Product technical requirement number
• Performance, principal structure or composition, and scope of application
• Contraindications, precautions, warnings and cautionary content
• Installation and operating instructions or diagrams; devices used by consumers themselves also need specific safe-use guidance
• Maintenance methods, and special storage and transport conditions
• Date of manufacture, and service life or expiry date
• Accessory list, including replacement cycles and methods for accessories, attachments and consumables
• Explanation of the graphics, symbols and abbreviations used on the label
• Date the instructions were prepared or revised

The warnings and precautions section is itself specified:

• intended users;
• potential hazards and use limitations;
• protective and corrective measures if something goes wrong during correct use;
• necessary monitoring and control measures;
• single-use marking;
• sterilisation method, and what to do if sterile packaging is damaged;
• requirements when the device is installed or used together with other devices;
• possible interference with other products;
• adverse events, or components that may cause side effects;
• disposal requirements at end of life.

Reusable devices must additionally state the reprocessing procedure — cleaning, disinfection, packaging and sterilisation methods — and the permitted number of reuse cycles or other limits.

The label: a shorter checklist

• Product name, model and specification
• Registrant or filer name, address and contact details; for imported devices, also the agent’s name, address and contact details
• Registration certificate number or record-filing number
• Manufacturer name, address, production address, contact details and production licence or filing number
• Date of manufacture, and service life or expiry date
• Power supply connection conditions and input power
• Graphics, symbols and other content required by the nature of the product
• Necessary warnings and precautions
• Special storage or operating conditions
• Warning marks or Chinese warning text where the device damages or harms the environment
• Warning marks or Chinese warning text where the device emits radiation

Where the label is physically too small to carry all of it, the minimum is product name, model, specification, date of manufacture, and service life or expiry date. The label must then say explicitly that the remaining information is in the instructions for use. That last clause is a permission with a condition attached — omitting the pointer is itself a defect.

What you may not say

This is the clause that catches exporters, because compliant English marketing copy becomes non-compliant Chinese labelling the moment it is translated literally. Prohibited on both the instructions and the label:

• Assertions or guarantees of efficacy — “best therapeutic effect”, “guaranteed cure”, “cures everything”, “eradicates”, “instant effect”, “completely free of toxic side effects”
• Absolute language — “highest technology”, “most scientific”, “most advanced”, “best”
• Statements of cure rates or effectiveness rates
• Comparisons with the efficacy or safety of other companies’ products
• Promissory language such as “insured by an insurance company” or “money back if ineffective”
• Use of any organisation’s or individual’s name or image as proof or endorsement
• Misleading statements that make a reader feel they already have a condition, or that they will contract or worsen one by not using the device, and any other false, exaggerated or misleading content
• Anything else prohibited by law or regulation

Read that list against a typical device brochure. “Clinically proven 98% success rate” fails on cure rates. “Recommended by leading cardiac surgeons” fails on endorsement. “The most advanced platform in its class” fails on absolute language. “Outperforms conventional systems” fails on comparison. None of these are unusual claims in an English catalogue, and all of them are ordinary marketing language somewhere. In a Chinese instruction leaflet they are a regulatory defect, and the leaflet is inside the box customs is examining.

The practical consequence is that the Chinese instructions cannot be produced by handing the English original to a translator. Someone has to decide what the document is permitted to say before anyone decides how to say it.

Changing a document that has already been approved

Instructions for use are submitted to the regulator for review or filing at the time of registration or record-filing, and the reviewed content may not be altered at will afterwards. The routes for change are narrow:

• Where the registration itself changes, the applicant amends the instructions and label in line with the change document, once that document has been obtained.
• Where other content in the instructions changes, the applicant notifies the approving authority in writing and submits a comparison of the changes. If no notice of disagreement is issued within twenty working days of receipt, the change takes effect.
• For record-filed devices, changes to the filing table entries, the technical requirements or other content of the instructions are made by the filer directly.

For a supplier this means label revisions have a lead time and cannot be treated as a print-room decision. A packaging change made abroad and shipped before the Chinese side has completed its notification is a shipment travelling ahead of its own paperwork.

If it is wrong

Instructions and labels that fail these provisions are penalised by the county-level drug administration or above under the Regulations on the Supervision and Administration of Medical Devices. Separately, at the border, an imported device is subject to statutory inspection and one of the two things examined on site is precisely whether the Chinese instructions and label are complete and conforming. A labelling defect is not a paperwork irritation discovered later by a regulator; it is a reason for the consignment not to be released.

Where this sits in a shipment

The useful sequence is: settle what the registration says, then write the Chinese instructions and label to agree with it, then print, then ship. Reversed — print abroad, ship, and resolve the Chinese text on arrival — it becomes an expensive problem, because relabelling under customs supervision, where it is possible at all, happens on the regulator’s timetable rather than yours.

If you are planning a first shipment of a device into China, the labelling is worth reviewing at the same time as the registration, not after it.