Mystery of China SFDA (State Food and Drug Administration) and CCC

[Obi-wan Kenobi]

In Reply to Parent Post by MIREGMGR

I'm sorry to disappoint, but while that's a brief question, it would be a lengthy and complex answer, and I have too much else to do to be the one who answers it.

Other people may feel differently, but I'm hesitant to provide some kinds of answers here, particularly in long chains of questions, because I don't want to replace the need for studying the regulations oneself in their entirety and formulating one's own understanding of their requirements and subtleties. This is that kind of question. A simple list-of-key-differences answer would be a disservice to the cause of improving regulatory understanding and performance.

I'm also not an SFDA expert, in that I can only read those elements of their system that they publish in English form. That, however, is enough for the brief "no" input I provided earlier.

Come on, MIREGMGR... after all this is a forum site... a site for discussion. Or else what is the purpose we meet up here then?
We meet up here to seek for ideas and some understanding and not for a perfect answer. However, we are glad there is someone who can give us a "NO" answer. This will makes us to seek for more answers and opinion.
What counts here is experience, and experience is not always written in the book.

[Obi-wan Kenobi]

In Reply to Parent Post by Michael Malis

OK - I will give it a try:

First, for registration with SFDA you will need to know product classification (Class 1, class 2 and Class 3, but they are NOT thesame as FDA classes).
Second, what type of device do you have (Medical Device or IVD)?
Third, you will need 3 major groups of documents:
1. License of manufacturer
2. Authorization letters
3. Technical data and IFU

More details for technical documents required for registration in China:
* Biocompatibility data
* Catalog/Model designations
* CE Certificate (if applicable)
* Clinical Summary
* Component/Raw materials/Vendor list
* Declaration of Conformity
* ISO/QMS Certificate
* Letter of Authorization
* Product Description/Indications for use
* Sterilization Method/Location
* Name and Address of manufacturer
* Certificate of Manufacture and Free sale
* Annual Registration of Device Establishment
* Certificate of Free Sales (dependent on country, mostly EU)
* Certificate to Foreign Government (if product made in US)

I am sure that I forget something...

Regards,
Mike

Hi Mike,

Here's what I've found...

"The Certification and Accreditation Administration (CNCA) is responsible for managing the product approval, for issuing the CCC Mark, and for accrediting certification bodies.

Sixty-eight testing laboratories are recognized by CNCA. Specific product groups are specified for each laboratory and designated certification bodies can only appoint a laboratory according to the CNCA specified list.

The Safety standard is the Chinese GB standard having similarity to IEC and the Chinese EMC GB standard is similar to CISPR. Factory inspection is required with an initial inspection mandatory before certification.

To obtain the CCC Mark, you must meet the following requirements:

Provide two samples of your product
Authorization letter through an agent
Complete CB test report with a CB certificate\Factory inspection report
User manual in Chinese
Valid Chinese certificate of the AC power connector
CCC logo application form"

Source: http://www.goldencosmos.com/qualityinfo.htm

[Obi-wan Kenobi]

Why is the SFDA/ CQC/ CCC requirements are SOOOOOOOOO much of a secret?

[CBAL08]

Yes SFDA process indeed is a secret one....however if any one could give me the tentative cost of apporval process for SFDA in China would be great......secondly whats the time frame for approval process...Class I devices....Is aloting Distributor as Legal agent and After sales agent a good thing.....Please help.

[eva_deng]

http://www.sfda.gov.cn/WS01/CL0144/

cost list for sfda service

If you need help in translating ,send me a message.

http://eng.sfda.gov.cn/cmsweb/webpor...A45714547.html

Initial registration of import products

[CBAL08]

Thank yu for giving me the weblinks bout sad to say that I cannot read Chinese....Could it be possible to get an English one.

[MIREGMGR]

In Reply to Parent Post by CBAL08

Thank yu for giving me the weblinks bout sad to say that I cannot read Chinese....Could it be possible to get an English one.

There's a link to the SFDA English-language site near the top center of the linked Chinese-language page.

However, there is no equivalence between the two language-sites. The English-language site has only a fraction of the content. In some instances where a topic is addressed in English, I'm told the English-language site appears to be translated as a summarization rather than literally and authoritatively.

[eva_deng]

cost for apporval process of import drugs is￥ 4，5300.