Medical Device Import/Export Translation Requirements for each country

K

KAMay

#1
Does anyone have a list, or a link to a list, detailing export/import requirements for each country in relation to Directive 2007/47/EC and translating manuals/software (For example, I saw the post about Royal Decree 1591/2009 for Spain..)

I've been googling each country individually but thought if I could find a list it would save me some time

Is anyone else as distressed as me with trying to get to grips with the translation requirements for software in a medical device by March 21st :confused:
 
Elsmar Forum Sponsor
U

Umang Vidyarthi

#2
Re: Import/Export translation requirements

Does anyone have a list, or a link to a list, detailing export/import requirements for each country in relation to Directive 2007/47/EC and translating manuals/software (For example, I saw the post about Royal Decree 1591/2009 for Spain..)

I've been googling each country individually but thought if I could find a list it would save me some time

Is anyone else as distressed as me with trying to get to grips with the translation requirements for software in a medical device by March 21st :confused:
Someone here may be able to help you with a list, for translations you may try This Link.

Umang :D
 
M

MiaQMS

#4
Re: Import/Export translation requirements

Hi...I've been struggling with this myself. How is everyone tackling this in their procedures?
 
K

KAMay

#8
Thanks Blewispunk, these lists are great..

My only question - I was under the impression that 'for professional use' was no longer an excuse to not translate into the National language, all of these lists still have that as an option for some countries, is that right?
 
A

Alexisss

#9
I can only speak for the Greek transition law of the MDD:
Class I and ClassIIa can not have Greek instructions if they are for professionals' use, ANDDDDDD you get a perimission from the National Competent Authority.

Which means that for whatever products you have for professional use, you must get permission from the Greek NCA ("EOF": www.eof.gr). If you do decide to do it, i wish you good luck with all my heart :rolleyes:

But here comes another point, as I mentioned earlier: having an "open" market in Europe, means that suppose you are in England and you sell your product to a customer in England for example, and this customer then ships the product to a company in Greece. The Greek NCA will have to run after the manufacturer. But you did not do something wrong.

In this way, everybody who does not have instructions/labels for each specific country, must be printing on the labels "not for sale in A C B D E countries". Can you imagine what will happen ?

I am seriously thinking of informing a member of the European Parliament on this, and have him file a formal question at the Europarliament. DG Sanco must look into this.....

Thanks
 
K

KAMay

#10
But here comes another point, as I mentioned earlier: having an "open" market in Europe, means that suppose you are in England and you sell your product to a customer in England for example, and this customer then ships the product to a company in Greece. The Greek NCA will have to run after the manufacturer. But you did not do something wrong.

In this way, everybody who does not have instructions/labels for each specific country, must be printing on the labels "not for sale in A C B D E countries". Can you imagine what will happen ?

I am seriously thinking of informing a member of the European Parliament on this, and have him file a formal question at the Europarliament. DG Sanco must look into this.....

Thanks
Very good point, it almost strikes me, that to cover all possibilities you need to have 22 versions of the IFUs etc (I think there is 22 languages) That is a financial nightmare for us!
 
Thread starter Similar threads Forum Replies Date
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
A Brazil - Import Medical Device Spare Parts - Without license Other Medical Device Regulations World-Wide 5
P Import-Export of Medical Device components into the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 24
G Transfer of Import Licenses - Medical Device Regulations in South Africa Other Medical Device Regulations World-Wide 5
G Import to Export through a Distributor - Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom