Dear Buket,
The OGYEI link that Péter shared in 2022 is still good. If you read that page, they explain that registration is required for companies domiciled in Hungary.
Germany is a member state, too, so a German manufacturer with a device conforming to MDR or IVDR can freely place it on the market there.
(Happy retirement, Péter!)
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Anne LeBlanc
United States
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Original Message:
Sent: 22-Jun-2023 09:57
From: Peter Miko
Subject: DISTRIBUTION OF MEDICAL DEVICES IN HUNGARY
Dear Buket,
thank you for your mail. Unfortunately, I cannot help, as I have retired and do not follow the developments in the area since early 2023.
with best regards
Péter Mikó
Original Message:
Sent: 6/21/2023 4:58:00 AM
From: Buket Meric
Subject: RE: DISTRIBUTION OF MEDICAL DEVICES IN HUNGARY
Dear Peter,
I would like to ask if as a Legal Manufacturer/Distributor (not domiciled in Hungary) located in Germany should we need a local licence holder in Hungary to perform local registration into the OGYEI?
Is the medical device registration a kind of electronic submission or not?
If so, what are the document and information requirements which should be provided to local representative? Is there a registrations fee?
Are Letter of Authorization and Free Sales Certificate from CoO required?
How long it takes to submit registration and get approval? Is there any notification certificate delivered due to the approval?
Thank you so much in advance.
Best regards,
Buket
Alsanza Medizintekhnik und Pharma GmbH
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Buket Meric
İstanbul
Turkey
Original Message:
Sent: 17-Apr-2022 12:16
From: Peter Miko
Subject: DISTRIBUTION OF MEDICAL DEVICES IN HUNGARY
Dear Valentina,
as Hungary is one of the Member States of the EU, the devices to be marketed need to be CE-marked and have valid DoC. In case the ERs are not fulfilled, CE-marking is not possible, therefore the device cannot be marketed (as in any EU MSs). You may find useful information here: Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (gov.hu)
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
Original Message:
Sent: 15-Apr-2022 05:16
From: Valentina Faziani
Subject: DISTRIBUTION OF MEDICAL DEVICES IN HUNGARY
Hi everyone,
as regards distribution of medical devices in Hungary, if devices are manufactured and registered in a EU country and the conformity assessment evaluation was already carried out, it is not necessary to notify it to the Competent Authority in Hungary (OGYÉI), given that the essential requirements as of Annex I MDR (i.e., packaging, IFU and labeling in Hungarian, etc.) are fulfilled.
My question is, if the essential requirements are not fulfilled, how is it necessary to do in order to sell the products?
Thank you
Best regards
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Valentina Faziani
Regulatory Affairs Specialist
Thema s.r.l.
Italy
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