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.
When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.