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

[Obi-wan Kenobi]

Hi MIREGMGR,

If so, what do we need for the technical files and other documents to be submitted, then? Appreciate for your reply.

[Obi-wan Kenobi]

Hi Elsmarians,

Appreciate if someone out there can list out those documents needed for the technical file submission or pre-market approval.

[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

[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,

Thousand thank you...

I'm sure there is some differences in some areas and some could be the same thing. Otherwise, what is the purpose to harmonize the regulations by using the ISO 13485 when those regulation don't speak with the same language?

After all, if we take a simple device such as examination gloves, how is the technical documents that required? BTW, do we need CCC mark for household rubber gloves and examination gloves. As I noticed that the CCC is required for Latex Condom only under the Rubber Product Category.

[Obi-wan Kenobi]

Well, MIREGMGR what is the next thing besides of answering a "NO". Appreciate if you could share the differences between China SFDA and US FDA.

[Obi-wan Kenobi]

In Reply to Parent Post by Obi-wan Kenobi

Hi Mike,

Thousand thank you...

I'm sure there is some differences in some areas and some could be the same thing. Otherwise, what is the purpose to harmonize the regulations by using the ISO 13485 when those regulation don't speak with the same language?

After all, if we take a simple device such as examination gloves, how is the technical documents that required? BTW, do we need CCC mark for household rubber gloves and examination gloves. As I noticed that the CCC is required for Latex Condom only under the Rubber Product Category.

Still no answer and no contribution... well.. the SFDA and the CCC still a mystery to all then...

[MIREGMGR]

In Reply to Parent Post by Obi-wan Kenobi

Well, MIREGMGR what is the next thing besides of answering a "NO". Appreciate if you could share the differences between China SFDA and US FDA.

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.

[max.polix]

I would add that there are some "product specific" standards to be take into account when you submit what the Chinese call the "Product Standard".

(I see it is confusing: they call "Product Standard" a description of a standard product coming out of your factory)

For example, ultrasound diagnostic devices are supposed to follow the provisions of GB10152: a mixture of performance and safety requirements that are supposed to be the basis of your file.

m.p.