China's CFDA - Medical Device Validation Requirements

[Nyeli]

Anybody knows where do I find Validation requirements imposed by CFDA?

Thanks.

 

[planB]

Nyeli,

are you looking for any specific validation?

Would the information provided on the CFDA website help?

HTH, Gerhard

 

[Ronen E]

Nyeli,

are you looking for any specific validation?

Would the information provided on the CFDA website help?

HTH, Gerhard

I don't think that there's any guidance in there for validation.

Ronen.

 

[Nyeli]

yes, there is nothing much published with regard to validation.

 

[Gamula]

Dear Nyeli,

oh yes, there is not a lot. But I would like to ask you what kind of validation? There are numerous possibilities like sterilisation, packaging. etc.

Best,
J

 

[Nyeli]

Hello Gamula - I'm looking for process validation guidelines in general not specific to any process. Thanks.

 

[Gamula]

This is way to general....risk class, sterilisation?, active or passive device? I mean, the validation depends quite a bit on the device itself.

A general validation is wihtin the technical part and the section research data has a part calles product validation.

I hope you will find the thing you search for!

Best!:

 

[Ajit Basrur]

Anybody knows where do I find Validation requirements imposed by CFDA?

Thanks.

I would suggest if you have a local source in China, tell them to approach the CFDA and they would be able to help out.

The CFDA has the website in English and Chinese but the English site is not fully loaded with their guidance documents as Chinese.

 

[Gamula]

Sometimes, the google or bing translator is helpful in translating the chinese CFDA webiste. You can find some marginal data at least. But, a local source is almost mandatory for a relatively fast registration.