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Countries that require Medical Device Model Number Registration


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Good day,

Does anyone happen to know what countries require registration of specific model numbers?

For example, a manufacturer can only export cadastro medical devices to Brazil that are specifically listed on their Certificate of Free Sales and registered with ANIVSA. So if a product needed a new model number assigned to it(i.e., same product family but slight variation), it wouldn't be eligible for export until it wen't through the registration process and was added to a legalized and translated Certificate of Free Sale.

My understanding is that even if it was the same exact product except for a different model number(M-30.1 instead of M-30) it still wouldn't be eligible for export.

This the beginning of my list:


Please let me know what you think. Thanks.


Many countries do require you to register the exact part/item/model numbers and you cannot import numbers that have not been registered. If you intend to send unregistered parts (same product different part numbers), you will have to go through the entire registration process again as the country's customs do not have it in their system.

To my knowledge and experience: Australia, Italy, Spain, India, Brazil, Argentina, Japan, Panama, Peru, and Colombia can only import products that are registered in the respective country.

Hope I was able to answer your question.
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