Choose Medical Device Distributors prior to Device Registration?

Hi Guys,

I hope you can help.

My company, based in the UK, hold a CE mark for a class IIb medical device. I am putting together a report detailing the requirements for registration of this device in Japan, China, Russia, South Korea, Brazil and Canada and would like to know whether I need to have chosen a Distributor/Importer for each of these countries BEFORE I can fill out the application forms for registration, or can these be selected once registration has been awarded.

Your help will be very much appreciated.

Thank you in advance,

Jo

I believe in all of those countries other than Canada, the registration or equivalent process must be undertaken by a party that is located within the subject country. This might be your distributor, or a third party registration agent, or your own in-country affiliate office if such exists.

This consideration might be related to your question, depending on how you approach it.

Thank you Miregmgr, but I think I need to rephrase the question:

If you choose not to use a Distributor to register your product in these countries and utilise the services of a local agent who does not distribute product, would you have to declare on the application form who your eventual Distributor is going to be, or can you select them after you've been registered.

My understanding is that in Japan, Canada and Brazil, a distributor does not have to be declared at time of registration. We have a China registration that did include declaration of a distributor, but I don't think that was mandatory. Korea, I think, does require declaration of a distributor/importer. I don't know the answer to this question for Russia.

In the case of Korea, there is no requirement to declare who will be the distributor. Only the license holder will be declared when registering

In all cases excluding Korea and Canada, I have had to declare the importer/distributor.

For Brazil registration the importer must appear on your proudct and packaging labelling and this is approved through ANVISA during the registration process.

I can't 100% answer for Russia, as we are using a distirbutor as the registration agent however our registration (been in progress since June 2013 and changed several times) has included the declaration of the importer/distributor since the start.

For China you have to declare the intended legal agent, after service agent and distribution authorisation, and any changes to this after the fact are notifiable to the CFDA. Again, our current registration is through a distributor, who will own the registration afterwards and you will need their authorisation to change any details. If you register via a consultancy or dedicated legal agent, you may not have any issues in changing these details afterwards.

For Brazil our experience was somewhat different, in that the importer and distributor are different parties. Thus yes, we also had to identify the importer to ANVISA, but there was no identification of that importer on the labeling, and the distributor was not identified to ANVISA.

We got approval for a family of products through a third party agent, acting as our in-country Brazil Registration Holder (BRH) who declared themselves to be the importer of record. We didn't yet know at that time who would be the eventual distributor(s). The BRH didn't declare themselves to be the distributor, as that would have been non-factual.