Docs for Medical Device registration in China - List of certificates

[alyona]

Hello everyone!
Tell me please about a list of certificates which I should ask in chinese company to registration medical device in other country.
It will be CFDA, FDA. What else?

 

[JoshuaFroud]

Re: Docs for registration in other country

Hi Good Morning and welcome to the Cove.



The list of documents and information required will greatly depend on the country you wish to register the device in.



Also, I do not quite follow your post, you have a device you are sourcing from China and wish to sell it elsewhere and you are not the manufacturer? or are you the manufacturer?



Good luck!

 

[alyona]

Re: Docs for registration in other country

Hi Good Morning and welcome to the Cove.



The list of documents and information required will greatly depend on the country you wish to register the device in.



Also, I do not quite follow your post, you have a device you are sourcing from China and wish to sell it elsewhere and you are not the manufacturer? or are you the manufacturer?



Good luck!

Thanks.
Right, we are not manufacturer. I am looking the list of documents recuired for registration of chinese medical products on the territory of Russia Federation. For example for Europe it will be CE certificate, and we need to now what common certificate ask in chinese company.

 

[shimonv]

Hi alyona,
The regulation, standards and format for submission files in China are very different than in the west. Unless the company you are dealing with has product licenses in western countries (which is very rare) you are going to run into multiple issues with registering the products by yourself as a private label distributor.

 

[jawlong]

Hi,
According to me, it will better to contact with a reputed Medical device manufacturer. They will definitely make you confirm regarding your query. Except FDA & CFDA I know another two certificate named ISO & UL. If you want to know then you should contact Peterstechnology.com.
Thank you

 

[supadrai]

Here's our list for Russia (medical gloves) (EDIT: We are a Thai manufacturer):

1 Product specification
2 Declaration of Conformity
3 Instructions for Use (IFU)
4 Bio burden Reports
5 BSCI
6 Technical Documents/File
7 Clinical Study
8 Freedm From Holes - EN455-1
9 Dimension & Tensile - EN455-2
10 Protein - EN455-3
11 Shelf Life - EN455-4
12 EN1186 - Overall Migration Test
13 Essential documents
14 Cytotoxicity15EN374 - PPE
16 Irritation & sensitization reports
17 MSDS Report
18 Production Flow
19 Viral Penetration F1671
20 Certificates of Analysis
21 CE cert
22 GMP
23 ISO 9001
24 ISO 13485
25 Manufacturing License
26 Risk Analysis
27 Quality Manual File

And the cost is about 20,000 USD or so.

Russian Federation is our worst case scenario. They put India to shame when it comes to bureaucracy.

 

[WendyLu33]

I think ISO 13485, ISO 9001 and CE certificates are required, as well as FSC.