CFDA Registration Costs

Hi,

The current registration costs for a new class 2 product being imported into in China is approximately 30,000 euro (210900 RMB). However I have not seen the cost for a domestic product listed anywhere; it is "determined by provincial FDAs".

(http://www.namsa.com/blog/View/entr...cfda-product-registration-fees-close-to-final)

Does anyone have any experience of what a Chinese provincial FDA will charge?

Chris

 

I don't really have such experience.
But from what I heard, different province can have a large variation on the charge, and it may have some sponsorship or waive of payment for some new or innovative device (depends on the govt judgement).

If you have a local factory or local company in China, I suggest you to ask your local staff to ask corresponding province government. ( as each factory should apply to its corresponding province govt, you don't have much choice except paying unless you have a few or going to have a new factory in China ... )

 

Thanks Wing Lam, that matches what I have heard. To qualify as a Domestic Product, all manufacturing must be performed on-site. Just re-packing or re-labeling does not count.

 

I'm not that familiar with Chinese medical device regulations, but the CFDA website does have a page outlining the initial registration process, in which it states there are no fees.

If that is indeed the case, then it would seem that for a foreign manufacturer the main regulatory costs would be:
- Maintaining a Chinese agent
- Conducting Chinese clinical trials (if required)
- Conducting testing by CFDA approved test house (if required)
- Translating all documentation into Chinese

 

Thanks Mark, unfortunately, the cFDA guidance in English is dated 2013. In 2014 they completely overhauled the regulations and the process. The fees have gone from free to 30,000 euro per device .

 

The registration costs for domestic products will be determined by local FDAs. So far only one state has published it and others may follow sometime in the next year. However, by the looks of it, it will be miniscule compared to foreign products.

 

Hi Stephen, many thanks for the update. Can you tell me which province has published a cost and how much it is? Do you know if there are any special requirements to be classed as a domestic producer?

 

To claim as a domestic producer in China, these licence / registration shall be needed ( the English name if by google translate):

营业执照 - Business registration
组织机构代码证 - a Organization code certificate
税务登记证 - Taxation registration
医疗器械经营企业许可证 - Medical Device Enterprise License

For detail, you may reference a private company website that mentioned the registration flow / material http://www.newlandgames.cn/ ( that is in Chinese )

 

And for your interest, found one province that posted the Class II registration fee ( YMB 82,400) for domestic medical device

http://www.zhangzhou.gov.cn/cms/html/zzsrmzfmhwz/2015-12-02/1289425917.html

 

Many thanks, this is approximately a third of the cost for registering an imported product.

If you become aware of any other provinces publishing this information, please can you post it on here.