China Type Testing for Medical Devices & IVDs – NMPA Registration

TYPICAL CHINESE and CHALLENGING Type Testing

Type testing is unique Chinese, it is also called in-country testing or product/sample testing. Similar testings can be found also in Russia, Japan and Brasil (Inmetro).

China type testing is one of the most critical and time-consuming steps for foreign medical device manufacturers seeking NMPA registration. Also known as in-country testing, it requires the medical device or IVD to be tested according to applicable Chinese GB and YY standards and the Product Technical Requirements (PTR).

For overseas manufacturers, the challenge is often not the testing itself, but determining which specifications, Chinese standards, samples, test plan apply before the product enters the Chinese laboratory.

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

PTR and Type Testing: The Connection You Should Understand

The PTR should not be treated as a document prepared after the testing strategy has been decided.

The PTR defines important product performance and technical requirements that become the basis for the testing process. Therefore, inconsistencies between the existing technical documentation, PTR, Chinese standards and the actual product can create problems during testing and later during NMPA technical review.

Our PTR assessment helps identify potential testing gaps before the sample enters the Chinese laboratory.

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 with potential chinese agent. After confimation by testing institute, medical device can be sent to China. Normally it is better to chose one skillful engineer and a Chinese spoken expert to accompany the test. They can operate medical device and answer questions directly at 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.

If you complete successfully type testing, it seems to finish the toughst part at "marathon" of product registration in China!

*As of  2021 the type testing and testig report by qualified own - or third party testing institute are accepted by NMPA

Procedure, Time, Cost and Documents for type testing

1. Procedure

In figure 2 the important steps are illustrated at type testing. The contact person is mainly testing engineers at testing institute. Even during the technical review by NMPA the reviewer would have an exchange with testing engineers regarding the testing details. After the application of type testing, the drafted PTR will be evaluated by testing institutes before legal manufacturers sign 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. Normally because of high demand of testing there is long waiting time till exact date of type tetsting. 

2.How Long Does China Type Testing Take?

Waiting time in queue before type testing

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 to testing institute in which the application takes around 1 month.

Time of conducting 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.

3. Cost

The cost of type testing varies in 5k-20k EUR depending on product type and testing institutes.

4. Documents

• PTR
• Instruction for use in Draft (Chinese)
• Draft Labels (Chinese)
• Application form
• Risk management
• Usability test (if appicable)

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 

Outlook

Can EU or FDA Test Reports Be Used for China?

Foreign manufacturers often ask whether existing IEC, ISO, FDA, CE/MDR or other international test reports can replace China type testing.

The answer depends on the applicable Chinese requirements and the specific product. Existing reports can nevertheless be extremely valuable for:

• identifying applicable test parameters;
• preparing the PTR;
• understanding potential test risks;
• assessing differences between international and Chinese standards;
• preparing supporting documentation for the Chinese testing process.

We can perform a gap assessment between your existing international test reports and the expected Chinese testing requirements before you send samples to China.

This fits perfectly with your existing positioning around MDR → NMPA and international regulatory reuse.

Thought

It is not exactly comprehensible which key performance specifications are essential for type testing if there was no product-specific guidance or standard. It is also obviously unequal which core scope different testing institutes are  specialized on. It results in some “unreasonable” trouble shooting during the type testing. Find the reliable consulting partners with experience of interested product group and better with strong network with testing institutes.

At the moment, NMPA is aware of unavoidable disadvantage of type testing. They try to ease the policy to allow more qualified third-party testing institutes stepping in and in new notification accept self-report of testing. Hopefully one day the type testing will be shortened in range or abrogate by accepting most or all overseas testing report by accredited testing laboratories. It is speculated that the testing report of  medcial device by Chinese manufactuers will be accepted at globe authority at the same too.

PTR and type testing are typical “made in China”. For overseas manufacturers this testing is an absolute deceleration during the product registration in China. Without doubt it is mainly a repeated testing or even eximination covered by internal verification tests and other tests by extern testing laboratories as view of overseas manufacturers. However, it exists indeed some differences of Chinese and international standards which demands additionally.

Be aware that in the Chinese life cycle at supply chain, authority has each year focused products to be inspected and applicable testing items in Chinese standards.

Our China Type Testing Services

We support foreign medical device and IVD manufacturers throughout the China type testing process:

• Pre-testing gap assessment
• Applicable GB/YY standard and test-item assessment
• PTR preparation and review
• Testing laboratory selection
• Sample preparation and shipment to China
• Communication with Chinese testing engineers
• Testing schedule and project management
• Technical troubleshooting during testing
• Review of test reports
• Support with testing-related NMPA questions
• Integration of the final testing report into the NMPA registration dossier

Are you good at chinese testing? Make a self-test (part of e-E-Learning), we show some tips and results