medical devices

Should agents or distributors be involved in translations of medical device literature?

medical devices

A prevailing question on the minds of manufacturers and exporters of medical devices is how agents or distributors should be involved in translations of medical device literature. Should they be assigned to carry out the translations themselves, provide approval on translations or arrange for professional linguists to carry out the work? Should local markets therefore take ownership of translation, or should this be managed centrally at head office? As with any export activities, there aren’t straightforward answers to these questions. In our latest blog, we take a look at the involvement of local agents and distributors in the translation process from a risk-analysis angle and try to recommend the best courses of action.

Quality Control

For any Quality Control, Compliance and Regulatory Affairs department – sooner or later – the question of accountability for translations will arise. It is more often an afterthought since many companies, having operated for years under the non-direct sale model, will have assigned agents or distributors to carry out translations in the respective countries. Literature needing translation can range from marketing materials, packaging and labels, and more terminology-heavy documents such as technical files or Instructions for Use.

While your local agents or distributors may be native speakers and will posses a certain degree of industry knowledge, it can be a rather high expectation that they will be able to translate to a professional standard. If in some other cases, local agents decide to engage the services of a professional linguist to carry out the work, the manufacturer will most likely have no knowledge of their credentials and suitability for the task at hand. Both of these approaches thus bring bring to mind doubts regarding the overall quality of the translations.

It goes without saying that the safety of the patient comes first, which is evident from the very first stages of product design and testing. This principle should also govern the production of any literature that will accompany the product itself, including translation of said literature. A manufacturer whose product causes injury to a patient due to an error in the translations of the Instructions for Use will be held liable, irrespective of the agent/distributor actually having provided the translation. Even specialist insurance will not waive this risk.

Data Management

Many QA/RA professionals in medical device companies are scratching their heads when it comes to keeping track of all translations being produced across the different markets throughout the product-to-market life cycle.

Let’s imagine a typical scenario: a catheter manufactured in Britain is CE marked and actively sold by distributors in 10 EU countries. The agents represent the UK manufacturer at a few local medical industry exhibitions, distributing localised marketing materials, and also promote the product on the company website. The IFUs have been translated and are available in print format inside the product package and as downloadable PDFs available online. The translation process for all of these materials takes place in 10 distinct markets, with the processes applied varying from distributor to distributor, or agent to agent.

Leaving quality control aside, how can UK manufacturers keep track of all this literature being distributed under their brand name? If translations are not managed centrally, any updates or amends are very likely to be done in-market on an ad-hoc basis, without being captured across the board. Consistency will therefore become affected. With similar products or updated versions likely to be produced in the near future, wouldn’t it be useful to be able to readily tap into the previous content you have stored on file? By centralising the translation process with a reputable and trusted translation agency partner to take care of translations for all markets, they will use Translation Memory software to safely store your translations. This will allow you to tweak and reuse your content as much as possible to accelerate the new product’s time-to-market, and keep the terminology in line with the company jargon at all times.

Cost Efficiency

It can be tempting to shift the responsibility for literature onto your local partners in exchange for their exclusive market representation. This seemingly cost-effective way to enter a new market is however only a short-term saving. In the long run it may not only harm the brand, but bring on costly lawsuits and settlements related to the previously mentioned erroneous translations. On top of that, content is not managed in a structured way, and the cost-reductions and speed efficiencies resulting from utilising professional translation memory software are not being taken advantage of. A specialist translation agency partner will ensure that as more and more content is translated, these benefits are felt more and more year by year, reducing cost exponentially and alleviating the original spend.

So where do agents or distributors really come in handy?

Market research focus groups and customer feedback

Being closest to your target audience, they are well positioned to facilitate local focus groups preceding the launch of a new product. They will be also receive valuable customer feedback, which they can relay to you as the manufacturer.

In-market reviews

As with most translation projects, it is very useful to assign your in-country agents and distributors to review and approve translations once they have been completed by the professionals. This ensures that local insights into the relevance and appropriateness of the translated content are captured, to ensure it has the right ‘flavour’ for the end-users. It also ensures that any local company-specific terminology is utilised, which linguists or the UK team may not be aware of initially. A good translation agency will encourage this process and make reviews and market feedback capture easy and seamless.

If you are looking to launch a medical product into a new market overseas and have any questions about how to approach translation requirements, please contact a member of our team on + 44 (0) 1926 335 681 or email

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