Going to America, When can I register

[DutchMarten]

So the company I work for, a class I medical device manufacturer situated in the Netherlands, is looking into expanding to the US.

We have 2 potential distributors, either of which can act as our U.S. agent and we are exempt from most things difficult (e.g. 501K). However we still need to register our company and devices with the FDA. It seemed at first to me that registration was only possible in the period of oktober-december, which I did found a bit strange to begin with. However on reading 21 CFR 807.22 again it seems there is a distinction between intitial registration (new to the market such as we would be) and annual registration (with the before mentioned period).

Is it thus that you can register at any time when you come on new to the market, but after that have to renew the registration before every fiscal in the period between 01st october and 31st december? How will this work will with fee that you have to pay up front then? Say we would do an intitial registration in july, do you the pay the same amount for half a year as you would for the full year? Or is your initial payment discounted from the next year.

We're still pretty flexible in when to enter the market and this bit of information could assist in planning.
CFR - Code of Federal Regulations Title 21 (fda.gov)

Hope there's someone who can shed some light on this.

 

[Ed Panek]

I can answer the timing question. I believe the fiscal govt calendar is from Oct 1 --> Sept 30 of any year. So Oct to December is Q1

 

[DutchMarten]

Thank you. Right, I was under the impression that a fiscal year would just be from January to December.

Still don't understand how and if that would work if we would register in july, though.

 

[chris1price]

Hi, yes you can register at any time, but then have to renew in the Q1 period. You actually have to pay before you can register

There is a lot of information on the FDA website, but this is a good starting point.

Device Registration and Listing

 

[DutchMarten]

Ok so basically you pay $6,493 if you start in october and $12,986 if you start in september and then have to renew in october. That's an expensive month haha. However I do think in the end it doesn't really matter all that much as our projections for the market are that it will easily make up for either of those amounts.

It just seemed to me to be a strange logic for a government organization.

Yes I looked at the website but it wasn't really clear to me.

 

[Michael_M]

It just seemed to me to be a strange logic for a government organization.

Off Topic: Your making the mistake of thinking 'logic' applies. Sorry, could not help inserting a joke. You can go back the proper topic now.

 

[mihzago]

Most organization that have an annual membership charge you full amount for the membership/registration regardless when you sign up, so the FDA is not unique in this.

If you plan to launch in September, then you may as well just wait with the registration until October 1st.

One more thing. You mentioned distributors and US Agent. Keep in mind you also have to appoint an Initial Importer, who also has to register and pay the fee.

 

[DutchMarten]

Most organization that have an annual membership charge you full amount for the membership/registration regardless when you sign up, so the FDA is not unique in this.

If you plan to launch in September, then you may as well just wait with the registration until October 1st.

One more thing. You mentioned distributors and US Agent. Keep in mind you also have to appoint an Initial Importer, who also has to register and pay the fee.

That's true.

Thank you for drawing my attention to the initial importer. I've looked into the Initial Importer and the US agent. As I understand it the US agent is a more administrative role although they also facilitate communication between the FDA (and provide information) and the manufacturer, whereas the Initial Importer is a more extensive role in the sense that they are responsible for regulatory compliance within the US, correct?

How does this usually take form? Can both roles be taken up by a company that is the distributor of our products in the US? Or is it better to have a seperate specialized company or even set up a subsidiary company to take on the role of Initial importer (since it has to deal with regulatory compliance and company sensitive information). There's quite some information on the US agent on the FDA website, but the information on the Initial Importer is limited to a few sentences in a part about definitions of establishment activities.

 

[mihzago]

Similarly to the US Agent, almost anyone with a US address can also be the Initial Importer; however, as you noticed, the importer has a few additional responsibilities related to regulatory compliance (complaints, MDRs, recalls, initial contact for any questions from US Customs). As a result, many distributors don't want to get involved.
Also, importers must register and pay establishment registration fee, whereas US Agents do not, which is why many US Agents don't offer this service.
It may be cheaper and easier to find a consulting firm that offers Initial Importer services.

 

[DutchMarten]

Thank you, this makes things a whole lot clearer for me.

As I've read on another topic you can have more than one Initial Importer (which given the word 'initial' seemed counterintuitive to me; I would think it would be the first one that registers). But this is not required, right. Especially given that some distributors might not be willing to take on this role. Or does every distributor that gets overseas shipments from us and then sells on the products have to be an Initial Importer, surely not right?

So as an example. If we have three interested companies that want to sell our products on the US market. We either pick one to be our US agent and Initial Importer or pick one to be our US agent and one seperate consulting firm to be our initial importer. Sales do not soley have to go through this distributor that is the US agent (i.e. the other two distributors have to buy through this company), it is merely a more close tie in terms of information and where the FDA can come knocking, correct?