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The human factors world did not rest. In China, the new Human Factors Guidance was published as a draft in May. It is open for comments until June 26th, 2020, but they can only be submitted by a company or institution based in China.

The Draft Guidance Paper comprises 66 pages in Chinese. First translations into English are circulating in the internet. But what does the new directive, which will apply to national and international manufacturers of medical devices of class II and III products, require?

It can be stated that many similarities can be found with the IEC 62366-1:2015 and the FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices". The new Chinese Draft Guidance Document reads like a combination of a process standard and a design handbook, as known from the former AAMI/ANSI document HE 48, which was later split into HE 74 and HE 75.

Half of the document deals mainly with the scope, the general principles, the risk management as well as the human factors design process and the documentation and regulatory requirements. The second half of the document, the appendix, covers general aspects of user interface design and cognitive psychology, including requirements for the information for use, the packaging and labelling. A separate chapter is also focusing on cultural differences that need to be considered for the design of a new medical product.

Below you can find an initial translation of the table of contents of the Chinese Draft Human Factors Guidance:

Foreword

  1. Scope of application
  2. Basis of human factors design
    1. Basic concept
    2. Core elements
    3. Common methods
  3. Basic principles
    1. Positioning of human factors design
    2. Use risk orientation
    3. Full life cycle management
  4. IV. Process of human factors design
  5. Verification and confirmation of human factors design
    1. Formative evaluation
    2. Summative evaluation
  6. Technical considerations
    1. Clinical trials
    2. Imported medical devices
    3. Off-the-shelf user interface
    4. Standards
    5. Change of human factors design
  7. Research information for human factors design
    1. Research report of human factors design
    2. Use risk assessment report
  8. Explanation of registration application dossiers
    1. Product registration
    2. Change of licensing items
    3. Renewal
  9. References

Appendix: Basic elements of human factors design

  1. Basic human capacity
  2. Use environment
  3. Display
  4. Connection
  5. Control
  6. Software user interface
  7. Instruction
  8. Labelling
  9. Packaging
  10. Cultural differences

The fact that various (unofficial) translations are currently circulating, makes it difficult to interpret the contents and requirements precisely. This applies in particular to the assumed binding nature of requirements. By definition, the verbal form “shall” means that compliance with a requirement or a test is mandatory for compliance with this a standard. However, for the Chinese Draft Guidance, the word "shall" can be found in the various translations with varying degrees of frequency, so that it is not clear when a requirement is mandatory and when it is only a recommendation.

The Guidance recommends 5-8 users per user group for formative usability evaluation and 20-30 participants are recommended for the summative evaluation - for a single user group. If several user groups need to be considered, 15-20 users per group are recommended. An explicit requirement that study participants must be national, Chinese citizens, as equally required by the US FDA Guidance, is not found in the chapter about the requirements on summative evaluation, but in a following chapter about special requirements for products that are imported and distributed in China.

For imported products, representative Chinese user groups need to be considered for summative evaluation to cover intercultural differences. Exceptions seem to be possible, if evidence is provided to ensure that there are no significant country specific differences and a safe and effective use is ensured.

The guidance is furthermore offering the possibility of comparing a new product undergoing approval with an equivalent product on the market. For approval, an analysis must be carried out to what extent the use related hazards and risks are comparable or whether additional risks may arise with the new product. In the latter case, these may have to be evaluated in a separate, summative study. If the risks are comparable, however, there must be access to and reference to the summative evaluation report of the device on the market.

Detailed requirements can certainly only be derived after the publication and official translation of the guidance. Certainly, the new guidance document does not only have a huge impact to manufacturers outside China who want to distribute their product in China, but also for the Chinese medical technology industry itself. It therefore remains to be seen to what extent the Chinese industry itself will contradict.