R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Small Label, Big Impact

There have been a bunch of countries recently that have changed their regulations to require a native language registration label on medical devices. These labels must call out a specific set of information including manufacturing location and address, and the Registration Number of the device. The label doesn’t need much information on it – these labels are usually very small. Countries like China and Brazil have had this requirement for quite some time, and recently countries such as Argentina, Venezuela and Mexico are following suit. I can truly understand why these countries are making this labeling requirement, as it makes it easy to check if a medical device is registered. However, these requirements are causing logistical problems for manufacturers which make the cost of registration in these countries prohibitive.

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