Product technical requirement and type testing of medical device and IVD in China

Type testing is special Chinese which applies to class II and III medical device and In vitro diagnostics (IVDs) for registration. To start type testing, manufacturer has to edit first Product technical requirement (PTR), followed by a local testing in a certified Chinese lab (institute). After testing, the final testing report and revised PTR is part of technical documentation.

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1.Product technical requirement

 

Product technical requirement (PTR) is a document submitted to testing institutes by manufacturer. It is a characteristic part of product indicating key specifications and testing methods derived e.g. from Chinese standards whereby the testing institutes check the specification in China.

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Don’t be surprised that PTR should be the first created document after the project start of product registration in China. The reason is that the following type testing takes long and the correlated specifications can then be updated in all submission dossiers. The final report will be issued by institute not always immediately.

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This is one of most important documents at submission dossiers. As a basis for type testing PTR is a kind of design output and test plan. The testing institutes will execute type testing in proposed testing method in accordance with national and industrial standards or own method. For e.g. electronic active MD, the heavy weights of typical type testing are safety - and Electromagnetic Compatibility on-site test in China. The final issued testing report acts as a design transfer.

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1.1 Table of content of Product technical requirement

 

The PTR is made of four chapters including appendix. We just list some typical items at PTR as overview.

 

1. Product name, variants and models:

e.g.

• Name, variant and model of medical device

• Naming rule of product version (e.g.  Easy Ventilator Innovation Version 1.2.0)

• Complete product release version

• Explanation of difference of products variants and models

 

2. Performance specification: it includes the main functional specifications of medical device as safety, software, quality control, modes.

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Not suggested in chapter 2 Performance specifications in PTR: validity studies, Sterilization validation studies, fatigue studies, in vitro degradation studies, human factor validation studies, reliability validation studies, magnetic resonance compatibility studies, biocompatibility studies, environmental requirements for medical electrical appliances.

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*the name of this chapter is confusing. Actually many electric parameter is not listed in PTR and will be tested in safety and EMC test. So exact here are critical specifications impacting safety and effectiveness of product.

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The performance parameters in product technical requirements refer to the functional and safety specification of finished products that can be judged objectively.

e.g.

Product size and weight

Product composition and configuration

Environment and electrical power requirements

Transport and storage conditions

Software environment

Data interface

Clinical function

User access control

 

3. Testing methods

Here the applied chapters of Chinese standards and summarised methods are described. If no Chinese standards as method were to reference, manufacturer should suggest own method from internal test too.

 

4. Definition the key definitions are cleared.

 

Appendix

For medical device, if possible, some descriptive characteristics can be indicated in appendix, such as product sterilization or non-sterile status, product validity period, main raw materials, production work flow, product main safety features, key technical specifications, key component information, MRI compatibility etc.

 

IVD elements

The requirement of PTR applies to medical device and IVD.

In the new guidance of PTR in 2022 there are 2 IVD aspects to consider:

• The test method should also clearly state the reference substance and the standard substance, the sample preparation method, the number of tests and the calculation method.

• For class III IVD, the main raw materials and production work flow shall be specified in the form of an appendix in the PTR.

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1.2 Context of Product technical requirement in China

 

Actually the role of PTR is vital through the life cycle of medical device. It is a part of design output at quality control regarding the safety and functional specification. The specification should be already verified at internal test. In figure below is shown interaction of PTR with other topics.