China Medical Device Product Registration

[Michael Malis]

Hi all,

Can anyone share their expertise in China's product Registration?

I know that process is taking a long time - 18 to 24 months.
Would like to know any tips of how to expedite this time frame...

Is there anything that can be done in parallel to get to this market faster?

Any help is greatly appreciated.

Thanks,
Mike

 

[sreenu927]

Hi Mike,

Appoint an agent who has worked with SFDA or having close contacts with SFDA, and the other thing is do things right for the first time itself, avoiding the turn around time for input requests and ur respone, which shortens the registration time significantly.

Recently, in the requirements, SFDA added, Free Sale Certificate (FSC) too.

Hope this helps.

Sreenu

 

[Michael Malis]

Sreenu,

Can you provide any details on thru this forum or private email?

Thanks,
Mike

 

[blewispunk]

Hey Michael,

I'm in the process of starting a SFDA submission so don't have the hindsight but can give you some links to places to start.

You can reach the SFDA website in English here: https://eng.sfda.gov.cn/eng/

The first thing you'll want to do is figure out your classification, which you can do using order no. 15 here: https://eng.sfda.gov.cn/cmsweb/webportal/W45649039/A56659173.html

The rest of the process is outlined in this SFDA regulatory guide on initial registration of medical devices: https://eng.sfda.gov.cn/cmsweb/webportal/W45649090/A45714547.html

Emergo has a nice chart summarizing the process that you can access here: https://www.emergogroup.com/files/uploads/brochures/CHINA-regulatory-process.pdf

I don't know how good their service is for China, but I have used Emergo for other services and been very happy with them. You can see their China services here: https://www.emergogroup.com/services-by-region/china

 

[RPag1951]

Hi
I believe that the main issue for the long delay is because your are dealing with the Chinese Government. They are extremely slow! Also it depends on what major city in China that you are working out of. Politics play a major factor!

 

[sreenu927]

Hi Mike,

I shared my experience through our China RA counterpart.
I haven't directly liaise with SFDA.

If you need any specific details, do let me know by mailing to sreenu.bme(at)gmail(dot)com or through this forum.

Regards
Sreenu

 

[dajobimi]

Hi Mike,

I am in the middle of product registration in China. Some experiences I
would like to share with you:
- You need a permanent legal agent / after sales agent representation in China, who is the primary contact for the legal authorities in China. This role could be fullfilled by a distributor, or independent organisation.
- All documents you submit, must be translated in Chinese. This also holds
for instructions for use, ISO Certificates, Declaration of Conformity.
- Your product (Class II and III) will be tested in an SFDA laboratory. This
could be done based on the instructions for use.
- You need to provide clinical evidence (e.g. a scientific literature evaluation)
that the product is safe and effective.
- The whole process can take 1 - 1.5 years.

And yes, I would recommend you consult a dedicated agency to do this for you.

Dajobimi.

 

[sreenu927]

Hi Mike,

Reg ur e-mail queries, I have got the following information.
1. For local manufacturers, SFDA audit the site and no site audit for Foreign Manufacturers.
2. So the processing time is more for local manufacturers than the foreign manufacturing sites.
3. You appoint an AFter Sales Agent to do submission, translation acitvities.

Regards
Sreenu

 

[Michael Malis]

Thanks to all for your information.

In reference to this, it is still not clear to me why the local manufacturer was able to get to the market faster...

We have people in China who are following up on a regular basis...
So what does the local company know that we don't?

 

[LeeFu]

Thanks to all for your information.

In reference to this, it is still not clear to me why the local manufacturer was able to get to the market faster...

We have people in China who are following up on a regular basis...
So what does the local company know that we don't?

If I may response to your confuse:

1. The local companies are required to test their product to be registried in authorized national test labs. SFDA, relies on these labs, to evaluate the product performance. But some foreign comanies want to use their existed test reports.

2. SFDA, sometimes, will request some information very difficult to prepare.

If you have any questions, you may send me email.