Chinese instruction for use and Chinese label

Chinese labelling of medical device or IVD is mainly meant Chinese instruction for use and Chinese label placed on product. Of course it exists also other marketing material as installation guide and datasheet etc.

1.Lifecycle of Chinese labelling

In accordance to Article 27 at “Regulations on supervision and administration of Medical Device” and “Guidance of Instructions for use and labels of medical device” (order 6, 2014), basic requirements on Instructions for use and label have to be fulfilled in China.

The specific requirements of Chinese labelling is often to find in product specific guidance and standards.

As in workflow in figure (just IFU as an example), the lifecycle of IFU at initial registration starts from a draft of IFU. This is at the same time an input for product technical requirement (PTR) for type testing at which you have to submit first time IFU officially. Make sure that the product name and key technical parameters are at least between IFU and PTR consistent.

After type testing the Chinese IFU might be revised if the technical parameters vary than given at PTR. Then it can take place that during technical reviews (normally twice) of submission dossier, some inconsistent contents, incorrect formulations and other performance claims could be suggested by reviewers. In this case, the following revisions of Chinese IFU are revised.

At the end, NMPA will issue NMPA certificate with certification number which should be added on final IFU. At this time, you should also leave revision date on final Chinese IFU.

Lifecycle of Chinese user manual of medical device

At change registration, IFU could not be submitted and can be revised depending on registration by manufacturer.

We intentionally not add lifecycle of Chinese label. It is not really binding due to the fact that only draft label is submitted. So manufacturer has free space to design Chinese label.

2. Chinese label

The requirements of Chinese label are derived from article 13 in guidance of Instructions for use and labels of medical device” (order 6, 2014).

1. Product name, model and specification

2. The name, address and contact information of the registrant or filing person, and the name, address and contact information of the agent for imported medical devices shall also be indicated

Note: registrant or filing person are legal manufacturer of class II/III or I medical device an IVD. Agent is Chinese authorised representative.

3. The number of the medical device registration certificate or the record certificate number;

4. The name, address, production address, contact information and production license number or production record certificate number of the production enterprise, and the name, address, production address, production license number or production record certificate of the entrusted enterprise shall also be marked with the entrusted production serial number

Note: If medical device was manufactured in China, production number is needed.

5. Production date, service period or expiry date

Note: There is only Chinese symbol for production date and expiry date. So validity is possible as alternative for expiration date

6. Power connection conditions and input power

7. Graphics, symbols and other relevant content that should be marked according to product characteristics

Note: Symbol should be in compliant to YY/T 0446: 2014 which contents only parts of symbols in ISO 15223-1: 2022. Additional symbols in home country as CE and can be unchanged if there was no Chinese requirements. However if the symbols raises a potential risk, it should be translated in Chinese on label otherwise it could be translated at IFU.

8. Necessary warnings and precautions

Note: Due to potential risk it is recommended to translate warnings and precautions in Chinese language on device or on components.

9. Special storage, operating conditions or instructions

10. For medical devices that have damage or negative impact on the environment during use, their labels shall contain warning signs or warning instructions in Chinese

Note: in Chinese language on device or on components

11. For medical devices with radiation, the labels shall contain warning signs or warning instructions in Chinese.

Above is an example of Chinese label. Among label requirements in the table, these items below are obligatory in Chinese due to limited space on label, otherwise it is to mention in IFU as statement "For other contents, see the instruction manual".

Product name, model and variant
Name, address, contact info of legal manufacturer
Number of Chinese certificate
Manufacturing date and period of validity or expiration date

3.1Chinese IFU of medical device

Requirements from article 10 Guidance on instruction for use and label of medical device, No. 6, 2014

(1) Product name, model, and specifications;

(2) The name, address, contact information distributor, for imported medical devices should also indicate the name, address and contact information of Chinese agent;

(3) The name, address, production address, contact information and production license number or production registration certificate number of legal manufacturer. If the production is entrusted, the name, address, production address, production license number or production registration certificate number of the entrusted enterprise shall also be marked.

(4) Medical device registration certificate number or filing number;

(5) Number of product technical requirements;

(6) Product performance, main structural components or ingredients, and scope of application;

(7) Contents of contraindications, precautions, warnings and tips;

(8) Installation and use instructions or diagrams. Medical devices used by consumers themselves should also have special instructions for safe use;

(9) Product maintenance and maintenance methods, special storage and transportation conditions and methods;

(10) Production date, validity or expiration date;

(11) Accessories list, including accessories, consumables replacement cycles and instructions on replacement methods;

(12) Explanation of graphics, symbols, abbreviations, etc. used in medical device labels;

(13) Date of preparation or revision of the instruction manual;

(14) Other contents that should be marked.

3.2 Chinese IFU of IVD

Below are critical parts written in Chinese IFU from separate guidance of IVD in China.

Product name
Packing specifications
Intended use
Principle of Inspection
Main components
Storage conditions and validity period
Applicable Instruments
Sample Requirements
Testing method
Positive judgment value or reference interval
Explanation of test results
Limitations of test methods
Product Performance Index
Precautions
Explanation of label
References
Basic Information
Medical Device Registration Certificate Number/Product Technical Requirement Number

or Medical Device Filing Number/Product Technical Requirement Number

Approval Date and Modification Date of IFU

4. Common mistakes of Chinese labelling

The most finding at Chinese inspection is Chinese labelling which should be consistent with submitted dossier to authority.

We list some typical mistakes below:

NOT update IFU from type testing, product description during and after registration
NOt follow guidance of medical device name
NOT follow the same wording of symbol at Chinese guidance
Forget to implement specific requirements of labelling at product specific guidance
Inconsistent content in label and IFU
Inconsistent content between Chinese certificate and Chinese labelling
NOT translate specific symbol on label in Chinese
Manufacturing date on label early than date of issuance of Chinese certificate
NOT apply for change of Chinese IFU
NOT have Chinese IFU in all packaging of selling units
Transfer all regional IFU unnecessarily to Chinese labelling

5. Management of international labelling of medical device

There are arsing labelling requirements global. It is not easy to keep a smart master labelling plus have come variants of labelling. Unfortunately one IFU and one label of the same medical device can be not used in all markets.

Like in China, there is a continuous brief revision of Chinese IFU. To prevent penalty due to non-conformity of Chinese IFU and label by NMPA, a management system in term of procedure on Chinese IFU from product registration on should be established.

Contact us to have a checklist of requirements on Chinese IFU and labels, exclusively in comparison to labelling requirements at article 23, chapter III, at annex 1 of MDR I EU or to your own example.

The first check of Chinese labelling is FREE.