Clarification on Direct Shipment of Finished Devices from Vietnam to the EU

[Mariahhh]

Hi all,


We are an Australian manufacturer of Class I and Class IIa custom-made devices compliant with the MDR. Our contract manufacturer, located in Vietnam, is assessed under our QMS as a critical supplier and holds MDSAP certification.


We are considering shipping finished devices directly from Vietnam to the EU. Are there any regulatory concerns or restrictions with this approach? From my understanding, the FDA is the only authority that requires contract manufacturers to be registered.


As we are the legal manufacturer responsible for MDR compliance—not the contract manufacturer—could you please confirm if there are any additional compliance-related obligations that would apply to the contract manufacturer in this scenario?

Thank you in advance.

 

[Quindana]

You need to clarify in detail who is the importer, exporter, distributer and LM. Because as an importer or distributor in the EU you have much the same obligations as an LM would have. And you do want to keep control over all related processes. So for each process you need to clearly describe who is responsible for what and make sure you have the relevant controls in place or taken care of by your supplier (which is not a given). From that than follows who can do product/batch releases, who can consign shipment papers, who can do receiving on the EU side and who is responsible for incoming inspection and distribution to the customer on the EU side and who is responsible for customer complaints and execution of recalls. What makes this a bit more complicated is that next to the legalities of the EU-MDR there are also the jurisdictional items as the customer rights and data protection acts and all kinds of registration obligations. And then on top of that, as the LM you still hold the end-responsibility of the whole chain, but if you didn’t arrange a legally more complicated distribution correctly, in medical devices, you’ll run into trouble fast. And also you do not want to be responsible for items that got messed up, at a supplier and for which you are not actually in full control. Perhaps also check in EU’s “blue guide” on the description of responsibilities for each role regarding placing regulated products (so not only EU-MDR, but also the recently changed Environmental regulations like Energy consumption, use of packaging materials, RoHS and WEEE or consumer goods under EMC and LVD or items under machinery directive etc) on the harmonized EU-market under a CE label.

 

[Bengal]

Hi,

Please accept my apologise for hijacking your thread.

I'm working with a US based manufacturer who is about to be MDR compliant for custom Class III implantable and wanted to enter the AU market. I was wondering if a certificate of some sort was given after MDR was obtained and if that was able to be used as the Manufacturer Evidence and during the Device Applciation? Or did you have to go through a TGA conformity assessment to be included in the ARTG?

 

[EmiliaBedelia]

Hi,

Please accept my apologise for hijacking your thread.

I'm working with a US based manufacturer who is about to be MDR compliant for custom Class III implantable and wanted to enter the AU market. I was wondering if a certificate of some sort was given after MDR was obtained and if that was able to be used as the Manufacturer Evidence and during the Device Applciation? Or did you have to go through a TGA conformity assessment to be included in the ARTG?

https://www.tga.gov.au/products/medical-devices/manufacturing/obtain-and-maintain-regulatory-evidence/overseas-regulatory-evidence-options-medical-device-application

This webpage should answer all your questions.