Documents for export of non-CE product, manufactured in Italy, outside the EU

[Valery Kvant]

Dear all,
I do hope for your help in the following:

The Italian manufacturer had been producing a medical device with CE-mark till the May 2024. Then, the Company decided not to apply for MDR and CE-mark has been lost. The decision to have non-ce product has been made due to the fact that products are selling only outside the EU.
Now, we have to renew a certificate for this medical device in Kazakhstan. The Kazakh MoH asked to provide them with a kind of document to prove the registartion in Italy. But we don't have CE-certificate as well as FSC, as CE-mark expired in May 2024.

Please, advise, what kind of document can be provided to non-EU countries instead of CE-cert and FSC, as ISO 13485 only is not sufficient there.

Thanks for your help!

 

[Al_Z1]

Don't know, if it would be relevant to EU-produced medical device, but we registered our device in Kazakhstan based upon our own country (CIS, non-EU) national device registration, and it was ok for their MoH. May be you have EEU certification for your device, based on your former CE, or any national certification for EEU-part countries for your device? It possibly could help you with this update.
If anything else would be impossible, you could try to apply for EEU certification, but this procedure is long and relatively complicated and has its own specifics, for example, only test reports, made by specific EEU-approved test labs are accepted. Also, I am not shure, if relevant technical regulations for EEU are available in any language except russian.
HTH

 

[Valery Kvant]

Dear @AI_Z1 thank you for the response!
We'll try the option to provide the KZ MoH with the licenses, confirming registartion in other CIS countries...Because swith to EAEU regulation is not possible now - too long and too expensive procedure

Thank you!

 

[Al_Z1]

If your device is 1 or 2a danger class via EEU classification, than cerification is much easier, - you don't need test reports from EEU-approved labs, just any accredited labs, you don't need clinical trials, only clinical asssesment, possibly you don't need production inspection onsite. Also you can choose to do only KZ sertification, without Russia or any other countries, it should be faster and easier. You could discuss it via your authorised representative with KZ EEU NB (I guess, you have one authorised rep, cause you need it to do the first registration).

 

[Bob365]

Dear @AI_Z1 and @Vaert Kvant

I hope you might be able to help me. Just wondering if you found a solution to this problem?

I have almost the same problem, but with Taiwan. We do not have CE marking for our MedDev, it is made in the Netherlands and is being registered in Taiwan. They are requesting a CFS but iof course I cannot obtain one, they think there is a similar document available that lists our products and the manufacturer and is issued by the government (CIBG or Farmatec). We are FDA listed and have a CFG but this does not meet the requirement, they need one from the Netherlands. We are based in Australia but we do not sell in Australia so we cannot obtain one here either.

Many thanks in advance.

 

[Al_Z1]

List of documents needed is based on local registration requirements. Unfortunately, I don't know a thing about Taiwan medical devices registration requirements.
Taiwan FDA controls medical device registration. Google sent me to Registration of Medical Devices - Product Registration - Medical Devices - Food and Drug Administration, Department of Health page, may be there is something useful.

 

[Bob365]

@@AI_Z1 many thanks I will have a look.

 

[Bob365]

List of documents needed is based on local registration requirements. Unfortunately, I don't know a thing about Taiwan medical devices registration requirements.
Taiwan FDA controls medical device registration. Google sent me to Registration of Medical Devices - Product Registration - Medical Devices - Food and Drug Administration, Department of Health page, may be there is something useful.

Unfotunately this is what the consultant in Taiwan provided us, I am hoping the original poster might respond with their solution. Thanks anyway.