Hamburg – International commercial law firm CMS has published the DTx Legal Navigator, the first international guide of its kind to placing digital therapeutics (DTx) on the market. It provides practical guidance for a total of 18 jurisdictions, explaining in an easy-to-understand way the legal requirements and boundaries for placing a DTx on the market, promoting the DTx and getting paid for it. The guide thus assists in understanding the legally complex framework around DTx and getting to the heart of the issues. It also covers the key legal aspects that companies face when accessing the market and in the subsequent phase.
Dr Roland Wiring, a partner and lawyer in the Life Sciences & Healthcare practice, commented: “DTx is a growth market, with the question of international scaling becoming increasingly important. But what works in one market may not be legally permissible in another jurisdiction. As a result, companies that have successfully entered the market in one country find themselves grappling repeatedly with the regulations and legal requirements that must be met in other countries. The considerable regulatory hurdles that arise make it difficult for businesses. We can now offer the DTx Legal Navigator, a helpful and above all effective guide to tackling the legal jungle around the core issues of market access, marketing and getting paid across 18 countries.”
The CMS DTx Legal Navigator is divided into three parts: the key legal requirements with regard to the software’s essential attributes, the most relevant legal aspects of product marketing in the particular market, and legal issues related to selling the product.
The guide is now available online at https://cms.law/en/int/publication/cms-dtx-legal-navigator.
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