Traversing through the maze of regulations when it comes to domestic (US) labeling requirements can be extremely involved when marketing medical products. As medical product manufacturers market their products internationally, this task becomes even more daunting. Remember, labeling in the medical industry is not only isolated to “what is on the box”. International bodies (i.e. European Union and the Japan Ministry of Health, Labour and Welfare) define labeling very much the same as the US. FDA:
The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(k) defines “label” as a “display of written, printed, or graphic matter upon the immediate container of any article…” As we see, this pertains to “what is on the box”; however, Section 201(m) defines “labeling” as
“all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article’ at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.”
As one considers what is needed to be done to maintain compliance with international regulations, one must consider three important factors:
- International labeling regulations from the Ministries of Health differ (if only slightly) from US Domestic FDA regulations. Harmonization efforts have been pursued for many years now but full harmonization has not been accomplished. Don’t assume that because you r labeling is compliant with the US FDA that it is also compliant with International Ministries. Many international bodies will accept compliance with the US FDA standards; however this is not an “across the board” scenario.
- Many times there are labeling requirements for Import/Export in addition to the labeling requirements for the Ministries of Health. These governmental requirements must be considered in order to ship product into a country independent of what is required to market and sell the products once they are received in-country.
- There ARE language requirements for labeling in every country.
The first two points above are pretty straightforward and are firsthand knowledge to Regulatory Affairs professionals who have years of experience in the medical industry. However, point #3 is not always as straightforward as it may seem. Let’s take a brief look at what is involved.
Each country has an official language in which labeling MUST be written. There are some countries where the official language is English. In the cases where the official language is not English, the defense that all operators, end users, physicians, technicians, patients, etc. read and write English is not acceptable. A manufacturer simply cannot vouch for the level of English comprehension of the different groups of people previously listed. If there is an adverse event (someone is hurt or killed- i.e. patient, doctor, nurse, technician, etc) and the cause of this adverse event is traceable back to the labeling was translated incorrectly or not translated at all, the manufacturer is liable. Claiming not to know what languages are spoken in different countries is not an excuse either. Each country has an official language or official languages that are accepted; however, do not just assume that these are the languages in which your labeling needs to be written. There are exceptions, depending upon your product or how it is being distributed (sold for commercial use vs. investigative) that also must be taken into consideration. The best way to start is to first understand what the official language(s) are for the countries you will be marketing then check the requirements released by the Ministry of Health for that country. Your government agent (or Notified Body for EU) within the country or region will provide official guidance. Your medical translation partner, although unable to provide official guidance, can also point you in the right direction (unofficially) with their experience working with other medical manufacturers (i.e. we have many clients who sell products in X country and the languages they translate into are Y.)
Do not think you chances of getting caught being non-compliant are slim to none. Apart from an adverse event triggering six to sever figure law suits and recalls, investigations can be launched based upon government audits, custom officials, competitors, or unhappy customers. The benefits far outweigh the risks maintaining compliance with international labeling requirements.