The SME Guide

This guide is aimed to help researchers and innovators planning to develop, or who are inte the process of developing, medicines, medical devices, cosmetics and/or hygiene products.

This guide provides easily available, brief information about requirements for clinical evaluations and trials, market approvals, as well as a general understanding of the regulations of medical products.

For more detailed information, this can be requested using the question-button in the right column of each page. In-depth, product specific advice is also available at the Swedish Medical Products Agency through our processes for regulatory and scientific advice.

Current guides

Medicinal products for human use


Medicinal products for veterinary use


Cosmetics and hygiene products for humans


Cosmetics and hygiene products for animals


Medical devices



Advice at the Swedish Medical Products Agency.

 Regulatory Advice

 Scientific Advice


Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | | Contact information