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Medical Device Registration Around the World
January 24, 2017 - By: - In: Medical Device Translation - Comments Off on Medical Device Registration Around the World

Does your medical device firm want to expand its reach into new markets?

While the United States and the European Union are the two biggest markets for medical devices in the world, they are not the only markets. In fact, there are a number of opportunities available for medical device firms wanting to commercialize their products in other countries, and especially those with large populations, such as Australia, Brazil, China, India and Russia.

Before being able to access those markets and reap the rewards, however, your firm must register the medical devices you wish to sell and obtain regulatory approval in each market you want to enter. This often includes translation of the medical device’s user information and packaging materials. As your firm begins to map the opportunities, threats and requirements involved in entering different markets, here is what you need to know to get started with medical device registration and approval in five countries with large populations and significant market potential.


To sell a medical device in Australia, it needs to be registered in the Australian Register of Therapeutic Goods and receive approval from the Australian Therapeutic Goods Administration. The good news is that if your medical device has already received a CE Mark (which is required to sell a medical device in Europe), the process will be simpler.


To sell a medical device in Brazil, it must be registered and approved by the Agência Nacional de Vigilância Sanitária. However, if you do not have a physical location in Brazil, your firm has to name a Brazilian Registration Holder who will obtain the necessary approvals on your behalf.


To sell a medical device in China, it needs to be approved by the China Food and Drug Administration. As part of the process, your firm may or may not need to conduct clinical trials in China.


To sell a medical device in India, your firm needs to comply with the requirements of the Central Drugs Standard Control Organization. This includes providing proof that your firm’s medical device is approved for sale in your home market as well as authorized to be sold in Australia, Canada, the European Union, Japan or the United States.


To sell a medical device in Russia, it has to be approved by the Federal Service for Control over Healthcare and Social Development, also referred to as Roszdravnadzor, and receive a Declaration of Conformity certificate issued by Gosstandardt. The medical device approval process requires product testing to be conducted in Russia.

Need More Information?

Responsive Translation can help you navigate the regulatory requirements for most medical device markets, including any translation requirements.

For more information or to discuss your firm’s specific needs, please get in touch at 212-355-4455 ext 208 or

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