Law firm CMS offers companies guidelines for placing DTx on the market

20.10.2023 12:38

The international commercial law firm CMS has published the DTx Legal Navigator, the first international guide of its kind for the market launch of digital therapeutics. Companies can now find practical instructions for a total of 18 countries, which clearly explain the legal requirements and limits for the marketing, promotion and payment of digital therapeutics. The guide thus supports understanding and penetrating the legally complex framework for so-called DTx and covers the most important legal aspects that companies are confronted with when accessing the market and the subsequent process.

Comments on this Dr. Roland Wiring, partner and lawyer in the life sciences & healthcare sector: “DTx is a growth market. The question of international scaling is becoming increasingly important. But what works in one market may not be legal in another country. After successfully entering the market in one country, companies are often faced with the question of which regulations and legal requirements must be met in other countries. There are significant regulatory hurdles here that pose difficulties for companies. With the DTx Legal Navigator, we now offer helpful and, above all, targeted guidance to penetrate the legal jungle on the core questions of market access, marketing and payment across 18 countries.”

The content of the CMS DTx Legal Navigator is divided into three parts, which cover questions about the general and most important legal requirements for the necessary qualifications of the software, the most relevant legal aspects when marketing products in the respective market and the legal issues in connection with the sale of the Divide the product.

The guide is now online at https://cms.law/en/int/publication/cms-dtx-legal-navigator usable and accessible.