Hi, I am hoping someone has experience with registering products in China.

My situation is this: we are a European manufacturer of general IVD's (ELISA-kits), which are CE-marked by Declaration of Conformity.
Most of our production is outsourced to an ISO 13485 certified company, but we are handling final packaging, shipping, and after sales service incl. vigilance and traceability.
We are not ISO certified at present, but working towards this and quite far along.

We have found what seems to be a very proficient partner in China and would like to proceed with registration of one of our products. It is my understanding, that this entails
1. obtaining a Manufacturing Establishment License - in our name
2. obtaining product registration - via our partner
3. clinical trials - via our partner
4. application for approval - by both

I am wondering about the process for obtaining manufacturing establishment license.
Is it a requirement that we be ISO certified?
Will we be inspected? and if so, when?
Will our sub-contractor be inspected?
What is the timeline for this process usually?

Obviously, our partner has given some input to these questions, but I would like to double check their information as we are currently negotiating the contract. Any input on the issues above will be greatly appreciated.

Regards
Camilla

Hi Camilla,

When you refer to the Establishment Registration, are you refrring to the registration by China / US ?

As per the rgeulations, if your partner manufacturers the Class I device (ELISA kits fall under Class I), they will have to get Manufacturing Enterprise License issued by the local SFDA (State Food and Drug Administration). For this, approach the provincial office of the SFDA where your partner's plant is located. The SFDA visit plants annually, at a minimum.

Its very easy to get this license.

Hi Camilla,

When you refer to the Establishment Registration, are you refrring to the registration by China / US ?

As per the rgeulations, if your partner manufacturers the Class I device (ELISA kits fall under Class I), they will have to get Manufacturing Enterprise License issued by the local SFDA (State Food and Drug Administration). For this, approach the provincial office of the SFDA where your partner's plant is located. The SFDA visit plants annually, at a minimum.

Its very easy to get this license.

Thank you for replying so soon.
I am not sure what you mean by Chine/US? I am based in Europe.
I guess the situation is complicated.
We are based ei Denmark, Europe and are the legal manufacturer.
Parts of production is outsourced to a German company.
Our Chineese Distributor is assisting in the registration, and will be selling the product in China - but in our name.

They say that WE need to get the manufacturing license, since the product will be sold in our name, but by the Chineese distributor. I want the license in our name, so we are free to change representation in China, should the need occur.
Does this change your answer?

Camilla

Oh, I thought that you would want to manufacture the kits in China ! If the kits were to be manufactured in China, the SFDA wants the Chinese organization to get a "Manufacturing Enterprise license".

For any questions on product registration, have a look at this website - ITA (http://www.ita.doc.gov/td/health/chinaregs.html)