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.

The problem is that the product must be registered before it can be labeled, as the label cannot be created until the registration number is available. Then the label must be translated into the native language, usually at a translation vendor, and all products in inventory must be relabeled. In order to keep track of inventories, some companies are creating multiple country specific part numbers, the registration label being the only difference in the parts. This process is extremely costly and time consuming. It takes long enough to register products in the international market. Due to these labeling requirements, it can take several subsequent months for an already approved product to finally be able to reach its final destination. This increased cost has caused many companies to reevaluate their registration plans, and choose not to register in these countries.

I hope that country officials understand the full implication of this type of labeling requirement. In theory it seems like a small paperwork issue, but it has a true impact on which devices get registered in their countries. I wonder if country officials realize that in trying to improve the lives of their citizens, they have also restricted their access to products that could have made them more comfortable, healthier or even saved their lives.