Regulatory Open Forum

Hello all.  Could you give me your thoughts on a situation regarding supply chain and regulatory requirements please?

We're a British based manufacturer and sell Class I sterile surgical instruments to a distributor in the USA.  The devices are listed on FURLS and GUDID, we've got a US Agent, and our US distributor is our importer and listed as such on FURLS.  The devices are UKCA marked from our UK certification body, however they are not CE marked and are not distributed in the EU or N.Ireland.  All labels comply with UK MDR and 21 CFR 801 (Great Britain and America being our two main markets).

Our US distributor sells the devices they import from us to their end-user customers in the USA.  The US distributor is now wanting to sell these imported devices into Israel and Egypt.  Our devices are not registered into either of these countries, by us or by the US distributor.

We've sold the products legally into the USA but do we need to register our devices in Israel/Egypt before the US distributor exports them?  Do we need to comply with Israeli/Egyptian regulations, even though we don't place them on those markets? 

(I'm checking the US's distribution agreement though any comments would be helpful in the meantime).

I'd value your thoughts on this one.

Many thanks,

Dave

Hello Dave

The short answer is yes. Unless there is some sort of emergency exception, normally the Israeli registration holder (who could be the distributor in Israel) needs to register the device before importing and selling it, and a similar arrangement in Egypt. The US listing can help to expedite the process, and the US distributor could facilitate communications, but there are still some documents that may require the manufacturer's signature, and you would still have some responsibilities in case of vigilance matters. (Unless the US distributor is also putting them into a kit, repackaging, or relabeling and taking the manufacturer role.)

Hello all.  Could you give me your thoughts on a situation regarding supply chain and regulatory requirements please?

We're a British based manufacturer and sell Class I sterile surgical instruments to a distributor in the USA.  The devices are listed on FURLS and GUDID, we've got a US Agent, and our US distributor is our importer and listed as such on FURLS.  The devices are UKCA marked from our UK certification body, however they are not CE marked and are not distributed in the EU or N.Ireland.  All labels comply with UK MDR and 21 CFR 801 (Great Britain and America being our two main markets).

Our US distributor sells the devices they import from us to their end-user customers in the USA.  The US distributor is now wanting to sell these imported devices into Israel and Egypt.  Our devices are not registered into either of these countries, by us or by the US distributor.

We've sold the products legally into the USA but do we need to register our devices in Israel/Egypt before the US distributor exports them?  Do we need to comply with Israeli/Egyptian regulations, even though we don't place them on those markets? 

(I'm checking the US's distribution agreement though any comments would be helpful in the meantime).

I'd value your thoughts on this one.

Many thanks,

Dave

Good day Dave,

Wherever a finished medical device is used with a human patient, regardless of how it got there, needs to be properly registered, cleared, approved, and/or accepted in the country where the product is being used.  As the (legal) Manufacturer of the device, the company is completely responsible for quality and regulatory aspects where the product is sold and used.  Thus it is important to know where distributors may then be further selling your device to not get some out of the blue email/call from a regulator in Country X.  In your specific case, the medical device manufactured by your company would need to be properly registered or approved in Israel and Egypt regardless whether you sold it there directly or a US distributor is going to further sell-on the device.

There are some other options.  The US distributor can take the responsibility as the (legal) Manufacturer for placing those devices in the markets of Israel or Egypt, but then they would be responsible for all quality and regulatory (this would be a completely different business relationship with your company then).  If they are Class I sterile surgical instruments, there may be some expediated pathway or only a registration process which might be straight-forward (depending on the exact device).  If the distributor continues or proceeds to import into those countries, then that is a completely different situation your company will have in the relationship with them - because as the Manufacturer you are still legally responsible for those devices viewed by most all regulatory agencies around the world.

Hello Dave

The short answer is yes. Unless there is some sort of emergency exception, normally the Israeli registration holder (who could be the distributor in Israel) needs to register the device before importing and selling it, and a similar arrangement in Egypt. The US listing can help to expedite the process, and the US distributor could facilitate communications, but there are still some documents that may require the manufacturer's signature, and you would still have some responsibilities in case of vigilance matters. (Unless the US distributor is also putting them into a kit, repackaging, or relabeling and taking the manufacturer role.)

Hello all.  Could you give me your thoughts on a situation regarding supply chain and regulatory requirements please?

We're a British based manufacturer and sell Class I sterile surgical instruments to a distributor in the USA.  The devices are listed on FURLS and GUDID, we've got a US Agent, and our US distributor is our importer and listed as such on FURLS.  The devices are UKCA marked from our UK certification body, however they are not CE marked and are not distributed in the EU or N.Ireland.  All labels comply with UK MDR and 21 CFR 801 (Great Britain and America being our two main markets).

Our US distributor sells the devices they import from us to their end-user customers in the USA.  The US distributor is now wanting to sell these imported devices into Israel and Egypt.  Our devices are not registered into either of these countries, by us or by the US distributor.

We've sold the products legally into the USA but do we need to register our devices in Israel/Egypt before the US distributor exports them?  Do we need to comply with Israeli/Egyptian regulations, even though we don't place them on those markets? 

(I'm checking the US's distribution agreement though any comments would be helpful in the meantime).

I'd value your thoughts on this one.

Many thanks,

Dave

Hello Dave

The short answer is yes. Unless there is some sort of emergency exception, normally the Israeli registration holder (who could be the distributor in Israel) needs to register the device before importing and selling it, and a similar arrangement in Egypt. The US listing can help to expedite the process, and the US distributor could facilitate communications, but there are still some documents that may require the manufacturer's signature, and you would still have some responsibilities in case of vigilance matters. (Unless the US distributor is also putting them into a kit, repackaging, or relabeling and taking the manufacturer role.)

Hello all.  Could you give me your thoughts on a situation regarding supply chain and regulatory requirements please?

We're a British based manufacturer and sell Class I sterile surgical instruments to a distributor in the USA.  The devices are listed on FURLS and GUDID, we've got a US Agent, and our US distributor is our importer and listed as such on FURLS.  The devices are UKCA marked from our UK certification body, however they are not CE marked and are not distributed in the EU or N.Ireland.  All labels comply with UK MDR and 21 CFR 801 (Great Britain and America being our two main markets).

Our US distributor sells the devices they import from us to their end-user customers in the USA.  The US distributor is now wanting to sell these imported devices into Israel and Egypt.  Our devices are not registered into either of these countries, by us or by the US distributor.

We've sold the products legally into the USA but do we need to register our devices in Israel/Egypt before the US distributor exports them?  Do we need to comply with Israeli/Egyptian regulations, even though we don't place them on those markets? 

(I'm checking the US's distribution agreement though any comments would be helpful in the meantime).

I'd value your thoughts on this one.

Many thanks,

Dave