Research, development and the manufacturing of medical devices are becoming very important globally. The European Union and the U.S. are currently the largest markets for these types of devices. This doesn’t have to be the case, as there are other countries like Brazil, Australia, Russia, China and India.
It’s not just the question of hiring a professional translator and getting the medical devices translated and localised to fit the new language and market. Every country requires approval before the medical device ends up on the market. You need to register your medical devices business in each country and obtain regulatory approval. This does often include performing a medical translation of your medical device’s user details.
Australia’s medical device requirement
To sell medical devices in Australia, it has to be first registered with the Australian Register of Therapeutic Goods and approval has to be granted from Australia’s Therapeutic Goods Administration. However, the process is far easier if the medical device has a CE Mark. This is needed before these devices can be released into the EU market.
Before a medical device can be sold in Brazil it must be approved and registered by the Agência Nacional de Vigilância Sanitária. In China, a medical device has to be approved by the China Drug and Food Administration. In order to try and sell a medical device to the Indian market, your company will need to meet the Central Drugs Standard Control Organization requirements.
This means that you need to provide evidence that the medical device has been approved back in your home country for the purpose of selling. In Russia, before a medical device can be sold it must be approved by the Federal Service for Control over Healthcare and Social Development, also referred to as the Roszdravnadzor Declaration of Conformity certificate, issued by Gosstandardt, is required as well.
A professional translation is important
It doesn’t take much to work out that any country that a medical device is sold in will require an appropriate translation otherwise the agency approving the device will not understand its purpose. A good medical translation specialist can ensure the translation of the description and use of the medical device will be both appropriate and accurate and will be localised to meet the language requirements of that country’s market.