Requirements when moving locations - Class 1 Medical Device Manufacturer in the US

Hi All,
Our company, a Class 1 Medical Device manufacturer in the US, is moving locations in less than 6 months. What are the requirements as far as notifications to different countries regulatory bodies? Is there any place to find thins information in one place or do I need to check by individual country?

Many Thanks!
Nancy

Re: Requirements when moving locations - Class 1 Medical Device Manufacturer in the U

Nancy Allen said:

Hi All,
Our company, a Class 1 Medical Device manufacturer in the US, is moving locations in less than 6 months. What are the requirements as far as notifications to different countries regulatory bodies? Is there any place to find thins information in one place or do I need to check by individual country?

Many Thanks!
Nancy

Click to expand...

Hi,

As far as notifications go -

FDA: Update your establishment registration and device listing. There may be additional requirements under state legislation (the state(s) your facilities are and will be in).

EC: Contact your EC (Authorized) Representative - they are required to notify the the authorities.

If you specify other domains in which you sell, perhaps more specific advice can be provided.

Of course you'll have to handle the labeling change as well (probably already doing so).

I'm not aware of a single location where such requirements are listed for more than one regulatory domain. Sorry.

Cheers,
Ronen.

Re: Requirements when moving locations - Class 1 Medical Device Manufacturer in the U

Thanks, Ronen-
I have identified the FDA, Canada and the EU as the three agencies for which we (or our authorized rep) register directly. We use distributors for other countries to which we sell (e.g., Japan, China, Brazil and Audtralia), and they have had responsibility for any country registrations. I am thinking that we need to notify the distributors and not the country regulatory body directly, but I need a sanity check. Since you mention labeling, the other questuion that has come up is the labeling requirements for a prodcut that is built at our current location but shipped from our new one...... I am just starting to dig for answers and any input is greatly appreciated.

Re: Requirements when moving locations - Class 1 Medical Device Manufacturer in the U

Nancy Allen said:

Thanks, Ronen-
I have identified the FDA, Canada and the EU as the three agencies for which we (or our authorized rep) register directly. We use distributors for other countries to which we sell (e.g., Japan, China, Brazil and Audtralia), and they have had responsibility for any country registrations. I am thinking that we need to notify the distributors and not the country regulatory body directly, but I need a sanity check. Since you mention labeling, the other questuion that has come up is the labeling requirements for a prodcut that is built at our current location but shipped from our new one...... I am just starting to dig for answers and any input is greatly appreciated.

Click to expand...

As you have about 6 months time, and you will have to build up inventory to sustain your re-location and settling time, determine the volume / batches that you will build in the current location, and have your labels to meet this. There may be some safety stock labels that may go scrap, but this will take care of your present location labels and the cut-off batch details. The next batch onwards will be in your new location and the labels can as well be planned for them. You need to assess realistic dates and quantities based upon your experience. Once labelled, shipping from your new location is no issue as you have determined in advance where the product has been made.

Re: Requirements when moving locations - Class 1 Medical Device Manufacturer in the U

Nancy Allen said:

Thanks, Ronen-
I have identified the FDA, Canada and the EU as the three agencies for which we (or our authorized rep) register directly. We use distributors for other countries to which we sell (e.g., Japan, China, Brazil and Audtralia), and they have had responsibility for any country registrations. I am thinking that we need to notify the distributors and not the country regulatory body directly, but I need a sanity check. Since you mention labeling, the other questuion that has come up is the labeling requirements for a prodcut that is built at our current location but shipped from our new one...... I am just starting to dig for answers and any input is greatly appreciated.

Click to expand...

Hi,

I'm no expert on Canada, hopefully someone else will assist with that. For markets where a distributor is responsible for registration, it makes sense to me to contact those distributors and make sure that they're on top of things. For Australia I can tell you right away that the Australian Sponsor (=the importer who originally registered) will have to inform the TGA, and there may be some associated work. If you have a decent AU Sponsor they should be aware of the requirements and process.

WRT labeling, I tend to think that the location of actual manufacturing matters, and if certain units / batches are later shifted to a different storage / despatch location it shouldn't affect the label manufacturer address, but a careful review of the requirements for each domain is probably the right way to go. I assume the relocation is managed under change control, and that since it's such a big thing it has it's project leader, project team and project plan, so this kind of activity probably belongs there as one of the Gantt chart items...

Cheers,
Ronen.