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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.

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.

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.

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.

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:


  • 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.

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.

*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.

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


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.



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.

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.

Related regulatory items of Chinese PTR

& Guidance/standards

The source of testing method at PTR is from product specific guidance and Chinese standards. With these referenced requirements it makes the testing method reliable and reproducible.


& Type testing

The testing institute can only test the sample upon drafted PTR and issues the report.


& Product registration

As one annex of Chinese medical device ID the original PTR is needed for each registration.


& Clinical trial

PTR has to be submitted by the application of clinical trial. It means automatically that the clinical trial can only take place after successful type testing.



The final specification after type testing should be consistent with all marketing material especially instruction for use.



At sales and distribution activity like tender at hospital is PTR plus NMPA certificate a must to have PASSPORT to demonstrate the approved medical device and the functional specifications.

& Post market inspection

At inspection the product specifications in PTR are preferentially proved as one of the most popular findings by authority.

2. Type testing


Type testing is unique Chinese, it is also called in-country testing or product/sample testing.


Besides preparing submission dossiers in paper at product registration, the medical device must be sent to accredited testing institutes by NMPA in China, see figure. Type testing applies to class II and III medical device. The final testing report is valid for 1 year which is one of the important documents among submission dossiers. The revised PTR with  specifications will be reviewed by authority and issued as annex  together with NMPA product certificate after product approval.

Workflow of Chinese Type Testingof medical device

The workflow of type testing shows a really long process The workflow of type testing shows long process of type testing.which might weight one third of time and effort in the whole product registration.  The input of type testing is drafted PTR by legal manufacturers. After exiting waiting time the thrilling testing can be executed at testing institutes.  Normally it is better to send one skilful engineer and a Chinese spoken expert to accompany the test. Then it might be ideally toThey can operate the medical device and answer the questions directly at type testing. Parallel by waiting for testing report, the manufacturer can start the preparation of main submission dossier. At the end of technical review by NMPA, the testing report and revised PTR will be proved as well.

2.1 Procedure of type testing


The procedure of type testing is in figure above illustrated. You The contact person is now onlymainly testing engineer at testing institute. Even during the technical review by NMPA the reviewer would have an exchange with testing engineer regarding the testing details. After the application of type testing, the drafted PTR will be evaluated by testing institutes before legal manufacturer sign an agreement with them. At this time frame the Overseas manufacturer can then prepare the sample for testing and, imports it in China and even pre-tests  the sample simulating difficult testing scenario in home country.   Normally because of high demand of testing there is long waiting time till real type testing. At this time frame the overseas manufacturer can prepare the sample for testing and import it in China and even pre-test  the sample simulating difficult testing scenario. 


2.2 Time needed for type testing


Waiting time in queue after application of type testing: 3-6 months depending on testing institutes.

Not all medical devices are in the scope of the capability of testing institutes. In this case the manufacturer should apply at central NMPA for authorizing this test toe testing institute in which the application takes around 1 month.


Time of executing type testing: 3-6 months depending on product type

The time could be longer in case. There is unpredicted trouble shooting at site of manufacturers. There are always queue of diverse testing unit which must be followed each other instead of testing parallel.

On average, the testing of stand-alone software and passive MD are less time-consuming than electrical medical equipment. For last one, the safety - and electromagnetic compatibility on-site test have to be conducted in different testing units.

Time for final testing report: 1-3 months

Please support cooperative Chinese engineer to complete the test report.

2.3 Cost for type testing


Cost: 5k-20k EUR.

The cost of type testingIt varies in this range, also depending on product type and testing institutes.


2.4 Documents needed for testing


  • PTR

  • Instruction for use (Chinese)

  • Draft Labels (Chinese)

  • Application form

  • Risk management

  • Usability test (if applicable)



Active electrical medical device:

  • IEC 60601-1 and IEC 60601-1-2 report in ENG

  • Certificates of critical components

  • EMC contents (product components, power supply cables, list of critical components, supporting accessories for testing)

  • Electrical schematic

  • Circuit diagrams


Contact us to have a free check of your PTR or get example of PTR of similar products.

DO you know that specification at PTR should be addressed in early product design for global markets?

DO you realise that specification at PTR is to be checked in the whole design change assessment?

Do you recognize that a procedure for Chinese testing or even other regional testing leverage the global registration?

Have you experienced that the Chinese type testing could be outsourced to a separate consulting partner as registration unit?


Organize a kickoff meeting with us for any support, even self E-Learning and interactive on-demand workshop.

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