Regulations and requirements related to the registration of medical devices differ between continents and countries.

Fjord Consulting can support you in compiling relevant documentation, registration applications and in contact with authorities around the world.

In EU medical devices need to obtain a CE mark prior to being placed on the market. All documentation describing the design, development and manufacturing of the product are part of a technical file or design dossier and need to be available, and in many cases submitted, to the notified body in order to obtain a CE mark.

Similar regulations are applicable for the USA, where the documentation are compiled in a Design History File (DHF), and a Device Manufacturing Record (DMR). This documentation are part of the product approval application to FDA, a 510K or PMA application. Before the device can be placed on the market it needs a FDA approval.

Africa is a fast strong growing market for medical devices, and there is a need for innovative products that solve the problems and challenges in health care. Legal requirements in Southern Africa are approaching those found in Europe and the United States.