Medical Translation Regulations
By Surinder Singh
Partly reblogged from The Language Blog by K International with permission from the author (including the image)
Medical translation is serious business. Mistakes can be a matter of life or death. As such, medical translation is one of the most heavily regulated segments of the translation industry.
Translation vendors and clients alike must navigate a complex labyrinth of rules at the local, national and international levels in order to stay compliant. Regulations govern what material must be translated, how data is transmitted and stored and the translation process itself.
Medical translation requirements can vary greatly depending on the product in question and the target markets. In most markets you need to have public-facing documents such as patient information sheets, marketing materials and forms for clinical trials translated into the local language. You may need to translate into minority languages, as well. Most of the time, material aimed at healthcare professionals must be translated, too, along with patent applications and applications for regulatory approval.
Translation Regulations for Medical Devices
Medical devices are big business, amounting to €95 billion in sales in the European Union alone. To sell products internationally, medical device manufacturers must comply with requirements for all relevant target markets. Each country has its own regulatory body and its own standards. In the European Union, sales of medical devices are governed by the following directives, depending on device type:
- 90/385/EEC on active implantable medical devices (also referred to as the Active Implantable Medical Devices Directive, or AIMDD)
- 93/42/EEC on medical devices (aka the Medical Devices Directive, or MDD)
- 98/79/EC on in vitro diagnostic medical devices (Invitro Diagnostic Medical Devices Directive, or IVDD)
Translation requirements depend on the type of device and the target market. Materials that need to be translated could include but are not limited to marketing material, instructions for medical professionals and for patients and user interfaces for device software and firmware. Software interfaces may also need to be changed to accommodate local scripts.
Naturally, target languages for translation also depend on the desired market, the type of device being sold and the intended audience. In the EU, that might mean making marketing materials available in all of the 24 official and working languages of the member states. In other countries, expect to translate to the official language of your target market, and possibly into minority languages as well.
The type of device also matters. For example, currently the EU breaks medical devices down into four classes depending on the level of risk they pose to patients, with separate requirements for each category. Intended audience is another a factor- in a few countries, such as Ireland, the United Kingdom, Cyprus, Luxembourg, Malta and Poland, you may be able to provide medical device labelling in English only if the device is intended for use by medical professionals only. However, labelling a device “for professional use only” will not absolve the manufacturer of liability for injuries caused by inadequate translation!
It may seem like a minor oversight, but failing to provide appropriately translated materials can have serious consequences, including product seizures, denial of insurance coverage, and even criminal prosecution for medical device manufacturers. This is no place to cut corners!
Regulations governing medical translation, including for medical devices, are constantly changing. In fact, in September of 2012, the European Commission proposed new regulations to replace the current directives governing the sale of medical devices. These are expected to be adopted in 2014 or 2015 and to be phased in over the next several years.
Pharmaceutical Translation Regulations
Like medical devices, pharmaceutical products are strictly regulated in virtually every country, but each country has its own rules. In the EU, your company must comply with guidelines set up by the European Medicines Agency (EMA) and its Committee for Human Medicinal Products (CHMP), as well as local regulations. In Japan, you need the approval of the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), both of which require application materials in Japanese. In China, documents must be translated to Standard Chinese before submission to the State Food and Drug Administration (SFDA).
The scope of pharmaceutical translation projects can include everything from Phase I clinical research trials to final marketing materials and everything in between: Phase II clinical trials and all the associated paperwork, licensing agreements; process, MSDS and manufacturing documentation, packaging and information for both patients and healthcare providers. All of it must be properly translated into all required target languages. There is no room for error or ambiguity.
Some regulatory agencies (such as the EMA) also have technical formatting requirements for translated documents, including details like font size and colours.
Patient Privacy and Security
Medical translation projects often need additional data security safeguards in order to comply with laws protecting patient privacy. These laws can effect how materials to be translated may be transmitted and stored.
Translation Quality and the Medical Translation Process
Translations must be high quality and free of mistakes to pass muster with all of the different regulatory agencies. Even slight shifts in meaning can be enough to put patients in danger and throw your product out of compliance. Depending on the market and the agencies involved, specific quality control procedures such as back translation and reconciliation may be necessary not only as a matter of choice but as a matter of legal compliance.