Change of Medical Device Company Registered Address - Implications

[Sue789]

Not sure I have posted this in the correct forum?

I am a start-up medical device company and growing in size as the Company expands we move offices and have a new registered address in the UK each time. We are looking into a permanent registered address.

Once our product is for sale is there any problems having a Registered Address which is not our head office address and only a virtual office for forwarding address for mail and any visitors that turn up?

My company will be ISO 13485 and FDA 21 CFR 820 would this cause a problem to the notified body and the FDA or any other regulatory authority, the only thought I have is customer complaints.

I am aware that when we change our Registered address then all our labelling will need to be change and the product reregistered hence why we are considering this an option.

Any thoughts?

Not sure I have posted this in the correct forum?

I am a start-up medical device company and growing in size as the Company expands we move offices and have a new registered address in the UK each time. We are looking into a permanent registered address.

Once our product is for sale is there any problems having a Registered Address which is not our head office address and only a virtual office for forwarding address for mail and any visitors that turn up?

My company will be ISO 13485 and FDA 21 CFR 820 would this cause a problem to the notified body and the FDA or any other regulatory authority, the only thought I have is customer complaints.

I am aware that when we change our Registered address then all our labelling will need to be change and the product reregistered hence why we are considering this an option.

Any thoughts?

 

[somashekar]

Re: Change of Registered Address - Implications

The ISO13485 Stage 1 assessment will find this and then this will not stand a clearance for the Stage 2 assessment leading to certification.

 

[MIREGMGR]

Once our product is for sale is there any problems having a Registered Address which is not our head office address and only a virtual office for forwarding address for mail and any visitors that turn up?

My company will be ISO 13485 and FDA 21 CFR 820 would this cause a problem to the notified body and the FDA or any other regulatory authority (...)

The MDD says in Annex I, "address", without clarifying whether a postal address is sufficient or a street address is mandatory. I'm under the impression that a reputable CB will not issue a ISO13485 certificate on which is stated only a postal address, or some other address than where the certified work is actually done.

US FDA is very clear on this. https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM095308.pdf says (bold added by me):

The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.

There is an exception for not providing any address if the actual street address is generally known and generally available in standard references. There is no exception for instead providing a different address than the actual street address.

 

[Sue789]

Thanks for the reply, the address of my Head office will be an actual building so will have a street address we are thinking of a virtual office with 'Regus' who will forward any mail or visitors to our current location. The Regus address will be on all our labels under our company name.

I will be speaking a CB next week and will clarify with them.