The system you ultimately put together should not be targeted at a single regulation but should be designed to provide building blocks of functionality, which can be applied differently to the same products shipped into many different regulatory environments around the globe.
Waiting for new, nonbinding guidance from the FDA is less important than recognizing the increasing number of binding regulations emerging around the world.
A key to baking in flexibility is to maintain a global regulatory “knowledge base.” GS1 Healthcare maintains an up-to-date database for access by its members. One benefit of their database is that most of the documents have already been translated into English by a professional translator.
You also have the option of selecting a vendor to maintain this library of up-to-date regulations for every country, or you can choose to set this up as part of an in-house quality compliance team.
This library of country-specific regulations should be reviewed and refreshed regularly. Look at each country, your trading partner or customer in that country, and any product-specific requirements there may be. Information on global regulations should be maintained in a user-friendly format that standardizes the core data that is required, and it must be shared with the entire team.
This will assure the selection of the right code and label (2D barcode, stacked linear code, even human-readable where dictated).
Best practice is to track regulations in all countries, even those in which you do not currently operate. This will allow a smoother and more efficient transition to serialized production should the opportunity arise to expand into another region.
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![Instruments and consumables used for IVD [In Vitro Diagnostics] testing represent a $51.3 billion market in 2013, with a compound annual growth rate (CAGR) forecast of 7.2% between 2012 and 2017.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2013/12/hp_23148_bloodtest.png?auto=format%2Ccompress&fit=crop&h=167&q=70&w=250)
