Session 2.1 Type Testing

1.  Learning objective

In this session you should know the meaning, role and procedure of type testing of medical device in China.

2. Video

3. Type testing

a. Background

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 foreign medical device must be sent to accredited testing institutes by NMPA in China, after drafting “product technical requirement” (PTR).

Type testing applies to class II and III medical device. The final testing report is one of the important documents among submission dossiers. The revised PTR with functional specifications will be reviewed by authority and issued as annex with stamp together with product certificate after product approval.

The biocompatibility test report, pre-clinical study, shelf life validation report, packaging validation report are beyond type testing and these reports are accepted by NMPA.

b. Procedure

The workflow of type testing shows a really long process 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. Normally it is better to send one skilful engineer and a Chinese spoken expert to accompany the test. They can operate medical device and answer questions directly at type testing. Parallel by waiting for testing report, the manufacturer can start the preparation of main submission dossier. At technical review by NMPA, the testing report and revised PTR will be proved as well.

In figure the important steps of type testing are illustrated. The contact person is mainly testing engineer at testing institute. Even during the technical review by NMPA the reviewer would have an exchange with testing engineer regarding testing details. After the application of type testing, the drafted PTR will be evaluated by testing institutes before legal manufacturer signs an agreement with them. Overseas manufacturer can then prepare the sample for testing, import it in China and even pre-test the sample simulating difficult testing scenario in home country. 

c. Time

The type testing takes long as usual IEC electrical testing in YOUR home country and is made of preparation, special waiting time, testing time with trouble shooting and final report time.

Waiting time in queue before type testing

After application of type testing: 3-6 months depending on testing institutes.

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

There is not rare unexpected trouble shooting at site of manufacturers. There are always queue or pedning time 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 test have to be conducted in different testing units by different engineer.

d. Document for testing

Below are typical documentations for testing:

• PTR
• Instruction for use (Chinese)
• Labels (Chinese)
• Application form
• Risk management

For active electrical medical device:

• IEC 60601-1 and IEC 60601-1-2 report
• Certificates of critical components
• EMC contents (product components, power supply cables, list of critical components, supporting accessories for testing)
• Electrical schematic
• Circuit diagrams

4. Test