Good day Anon,
To answer your questions regarding marketing materials.
1. Yes they can, well anyone can translate marketing materials, even your own company. However, there is no requirements beyond those you establish by your own organisation what is required such as certificate of translation or conducting back-translations. Edit: while there is no "clear" requirement there are definitely expectations for what companies say their products can do and indications for use. While marketing materials are not labelling, the level of scrutiny might be similar depending on the regulatory region you are selling. In addition, translation of marketing materials should be reviewed carefully because any claims being made or transposition/translation of words can have a regulatory impact even for marketing materials. Remember, you as the (legal) Manufacturer are responsible for the medical device in the country sold including any related information such as marketing materials, brochures, and of course the labelling.
2. As noted above, be very careful about having distributors translate marketing materials, brochures, and presentations to ensure what is being conveyed. This is even more important for the Instructions for Use and training material, because even a single word translated wrong can have a significant regulatory impact. Your company should have the full awareness, understanding, and know what is being translated because the regulatory burden would be with the regulatory responsible - the company responsible for the medical device.
3. You might want to seek further expert advice on using different indications in different countries - especially on marketing material or videos which are posted in social media channels. Sadly, in my experience usually there is needed different marketing material for regions when the indications for use are different. The local regulatory authorities do not look favourably on companies which have mixed indications on the same IFU/marketing materials. Because this lends itself to much more off-label use of a device because the healthcare professional sees an indication and thinks: I can use the device for that too.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 30-Jan-2023 08:24
From: Anonymous Member
Subject: Marketing materials
This message was posted by a user wishing to remain anonymous
Hello,
I have few questions regarding marketing materials:
- Can the distributer translate the marketing material? Does the distributer must provide the legal manufacturer a certificate of translation? Should the manufacturer do a back translation?
- Can distributers translate presentations, brochures, IFU and training material (training material is part of our qualification to use our product)
- The approved indications for use are differ between countries – Can we add a disclaimer on brochures and videos that state the following: our system has WW distribution please, check that if the clinical indications for use discussed in this video are cleared in your country. We would like to avoid managing different marketing materials for each country.
Thanks!