Confusion on how requirements for CE mark affects medical devices that are planned to be sold only in China

[Mike W]

From my understanding, for medical devices to be sold in China, they require CE mark
1. But to get a CE mark, you need to conduct your clinical studies in the EU(?) population. (is my understanding correct?)

2. If your IVD is planned to be sold only in China because the assay tests for the presence of analytes/VIRAL STRAINS that are unique to that geographic region/population, how can you properly validate your test/clinical performance in clinical trials if the CE Mark requires you to test in the EU-where the strain youre testing for is so much more rarer than if you did clinical trials in China??

Appreciate any input here, thank you everyone!

 

[Billy Milly]

You need to perform your investigation following "EU" rules (reporting to EU CA etc.). This does not necessariliy mean you cannot include other geographical areas, respecting the mentioned rules for investigation.

 

[Cybel]

From my understanding, for medical devices to be sold in China, they require CE mark

Is that true? We are European manufacturer and to sold our medical devices in China we needed to undergo to a complex procedure of authorization in China, with tests performed in China. I think they did not even ask my CE certificate.

 

[Feninaar]

Your understanding regarding CE marking for medical devices is partially correct, but there are some nuances to consider:

1. CE Marking for Medical Devices
2. Clinical Studies Location and Population
   

It's important to consult with regulatory experts who specialize in medical devices and IVDs to navigate the regulatory requirements effectively.

 

[IS1027]

In China:

• Yes, they require CE marking, because they require Country of Origin Approval before the registration even begins.
• Depending on the device classification they might require testing your device in China or not. Class I devices do not require testing in China. However, classifications are not 100% equivalent between Europe and China.
• Regarding the clinical studies, the NMPA has specific requirements as to what they deem acceptable or not. Not sure about your specific case, but I think they might accept foreign clinical data, but you have to comply with all their requirements. If you plan to sell in China, you should have a Chinese representative. They would interact with the NMPA on your behalf and also should provide you with the relevant regulations that target your device.