The objective of this paper is to have an overview of different printing processes used to print medical products and packages and the regulatory requirements for printing process and inks used in medical device packaging. Printing is crucial in medical device products or packages, since it gives the information about the medical products to the user and variable printing like barcodes helps to give the traceability of the medical products that impacts on safety of patients. The printed information should be legible and readable throughout the shelf life of the medical products. In fact, without appropriate printed information on medical products or packages, a high risk is posed to the patients’ health, with the likelihood of using wrong medication or in the worst case, death. With such risk involved, this is why the medical device labelling is among the highest regulated for medical device packaging. Thus, The paper presents an overview of the commonly used printing processes for medical products and packages and regulatory standard requirements of printing processes and inks.
