Life cycle of Chinese IFU and Label 

Requirements on Chinese Instructions for use and label by NMPA

In accordance to Article 39 at “Regulations on the Supervision and Administration of Medical Devices” (Decree of the State Council No. 739, 2021) and “Guidance of Instructions for use and labels of medical device” (order 6, 2014), basic requirements on Instructions for use and label have to to be fulfilled in China. Compared to article 23, chapter III, annex 1 at MDR in EU, the requirements on Chinese Instructions for use and label are a kind thinned out and quite basic.

However, some items on Chinese Instructions for use and labels are often ignored and keep a potential finding by medical device authority NMPA in China. The reasons are diversified:

Sometimes the sources of translations of Chinese IFU and labels are different: internal marketing - and RA department, external translation office, local consulting company or own subsidiary in China and distributors in China.

Unfortunately it exists no controlling system of Chinese IFU by legal manufacturers consistently. Besides it, the registration process from dossier preparation to product approval takes almost 1.5 to 2 years for e.g. class II medical device. Actually there should be at least three revisions of Chinese IFUs in time manner, namely after type testing, after technical reviews by authority NMPA and after final issue of NMPA certificate.

Another close related topic is symbol. In China manufacturer should have the exact wording compliant to standard YY/T 0466.1: 2007 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements (draft in 2022).

Life cycle of Chinese IFU

From plan of submission dossier to delivery of final IFU to client after product approval in China

We suggest that legal manufacturer uses only one resource of translation of Chinese IFU and labels with controlling system. As in workflow below (just IFU as an example), the life cycle of IFU 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 IFU officially first time. Make sure that product name, variants/models and key technical parameters are at least consistent between IFU and PTR. Very often overseas manufacturers take care of draft of Chinese IFU. Chinese agent who is responsible for submission dossier, concentrates on PTR at basis of English IFU. The inconsistency happens not rarely.

After type testing the Chinese IFU might be revised if the technical parameters vary than given at PTR. Then it can occur that during technical review of submission dossier, some inconsistent contents, incorrect formulations and other performance claims are suggested by reviewers. In this case, the second revision of Chinese IFU is to follow.

At the end, NMPA will issue NMPA certificate with certification - and PTR number (the same) which should be added on final IFU. Meanwhile you should also leave revision date on final Chinese IFU.

Checklist of Chinese IFU and label

The checklist of IFU is derived from article 11 in guidance of Instructions for use and labels of medical device” (order 6, 2014).

Among label requirements in the table, these items are obligatory in Chinese if limited space on label, otherwise it is to mention in IFU:

See article 13 in guidance of Instructions for use and labels of medical device” (order 6, 2014):

• Product name, model and variant
• Name, address, contact info of legal manufacturer
• Number of NMPA certificate and product technical requirement (PTR)
• Manufacturing date and period of validity or expiration date

Special IFU requirements for electronic active device

There are also Chinese electronic standards series as IEC 60601. Special labelling requirements are to find in newest:

GB 9706.1-2020 (valid as of May, 2026, replacing GB 9706.1-2007)

Corresponding to IEC 60601-1:2012, edition 3, Medical electrical equipment—Part 1: General requirements for safety

YY 9706.102-2021 (valid as of May, 2026, replacing YY 0505-2012)

Corresponding to IEC 60601-1-2:2007, edition 3, Medical electrical equipment－Part 1-2: General requirements for safety－Collateral standards: Electromagnetic compatibility－Requirements and tests

Special IFU Requirements for standalone software

For additional IFU requirements it is wise to check general and product specific guidance. We list just some typical requirements:

Medical device software registration review guidelines

The instructions must reflect the software's functions, usage restrictions, input and output data types, necessary software and hardware, maximum number of concurrencies, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable) and other information, and clarify the software release version……

Software of Artificial Intelligence Assisted Detection of Medical Devices

1.      Conclusion of clinical trial

2.      Scope of indication

3.      Related requirements about data collection device and data collection process

4.      If applicable: The software only assists doctors in detecting lesions, and there is the possibility of false negatives/positives. A professional physician should comprehensively give a final conclusion on lesion detection based on the patient’s medical history, symptoms, signs, and other examination results, and verify whether further diagnosis and treatment is needed. decision-making and be responsible for clinical diagnosis results

IFU Requirements for IVD (draft in 2022)

1. Product name
2. Packing specifications
3. Intended use
4. Principle of Inspection
5. Main components
6. Storage conditions and validity period
7. Applicable Instruments
8. Sample Requirements
9. Testing method
10. Positive judgment value or reference interval
11. Explanation of test results
12. Limitations of test methods
13. Product Performance Index
14. Precautions
15. Explanation of label
16. References
17. Basic Information
18. Medical Device Registration Certificate Number/Product Technical Requirement Number

or Medical Device Filing Number/Product Technical Requirement Number

19. Approval Date and Modification Date of IFU

Electronic IFU in China

There is no rule in term of eIFU. In a notification, Chinese authority has said only that eIFU should be consistent with approved IFU.

You might know the European regulation 2021/2226 and 207/2012. In China manufacturer could use eIFU in a wide product group independent of professional user or implant.

We can be your smart database of Chinese IFU. Contact us, we fulfil the highest technical demand plus your customer need with Chinese clients.

Summary

There is a continuous revision of Chinese IFU starting from first version, during product registration to final product approval. To prevent penalty due to non-conformity of Chinese IFU and label by NMPA, a controlling system in term of procedure on Chinese IFU and label in the whole life cycle should be established.

CONTACT US to have a template of requirements on Chinese IFU and label, exclusively in comparison to IFU requirements in article 23, chapter III, annex 1 at MDR.

Do you want to train your marketing colleague working on Chinese labelling without Chinese knowledge, visit our on-demand workshop.