Hello Tetiana,
In answer to your questions:
- In most cases, the answer is always yes. There can be a number of reasons an address is changed as simple as moving manufacturing from one place to another. Or the reasons may be more complicated such as now outsourcing to an external entity. A change of address can have many significant changes, so in Europe as an example this would require a notification.
- Depending on why the address is changing, this may require a "supplement" audit for the EU. In the ASEAN countries, typically it would not require an audit, but there may be additional activities which have to occur such as providing update to an ISO 13485 certificate or similar.
- Yes, though again it depends on the country whereas in Europe this is accepted with of course a Quality Plan describing the address change transition, i.e. labelling, certificate(s), etc. Some countries in ASEAN it is only a notification, while others need further information which again a Quality Plan of the address change should be in place.
- This can vary from a few months to a few days depending on the country. As an example, if an audit is needed in the European Union this could take a few months to schedule. A notification to Japan may take a couple weeks to be accepted.
- This can vary significant because it depends on why the address is being changed. If this is a facility move from one location to another, there could be quite a number of documents impacted and some which would need to be provided.
Hope that helps, in the European Union because it is the EU, can deal directly with your Notified Body or local registration. Though in ASEAN would need to consider each country which the product is current registration or approved.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 05-Jan-2024 01:37
From: Barry Evers-Buckland
Subject: Legal manufacturer's address change
Tetiana, I can't answer for the Ukraine but for both the EU and ASEAN countries the answer is yes.
2. Generally speaking no but it is possible for a high risk device. They may ask you for a copy of the audit finding from the Notified Body to ensure that the quality management system still meets the requirements. They also may ask for the reasons for the change.
3. to the best of my knowledge yes but don't take to long about it. Also, be aware of the fact that you may be importing product which has the new address but your customs declaration may have the old address.
4. In most ASEAN countries it varies
5. It varies .
Regards
Barry
EBR Consulting Services
Australia.
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Barry Evers-Buckland
Director
Eltham North VIC
Australia
Original Message:
Sent: 04-Jan-2024 05:19
From: Tetiana Slavnikova
Subject: Legal manufacturer's address change
Hi! I need some kind of advice or guidance, what happens and what should be done if the legal manufacturerer's adress changes? For EU, Ukraine and ASEAN countries.
1) Is the change notification required?
2) Is an audit required?
3) Is it possible to sell devices in transition period?
4) Timeline to complete change notification
5) Documents required?
I will be very thankful for any guidance and reference links.
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Tetiana Slavnikova
HTW Berlin
Berlin
Germany
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