High Risk Medical Device Type Testing (China Requirements)

K

kgwoz

Hi everyone,

Is there a typical number of samples that are required for type testing in China (high-risk device)? My client is trying to plan a build and needs to know how many devices to make for the type testing?

Thanks,
Karen
 
G

Gert Sorensen

When you are entering into markets like China, Korea and other far east markets you need to make sure that you have a knowledgeable partner with experience there, chances are you will not get your product to market otherwise.

Generally, the SFDA is trying to base most of their system on the FDA system, and I would suspect that you will need to prove that you have used good statistics when designing your clinical trials.

From the regulation:
Chapter II The Administration of Medical Devices
Article 7
The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council
 
B

beflying163

Generally,the number of samples are decided by what your samples are and its standard; you can call the testing center to get the detail!
 
J

Jamiechina

Generally,the number of samples are decided by what your samples are and its standard; you can call the testing center to get the detail!
Yes, but I think it's better to find a good agency in advance. Then you can get the answer from the agency.
 
M

mawemoto

There is no "typical number of samples" that are required for type testing in China (high-risk device). Sample size(s) are determined by the calculation of surface area of the device. Your in country representative should be able to assist you or call the testing facility to assist you with this request.
 
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