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
Guide

   

Medicinal products for veterinary use
Guide

   

Cosmetics and hygiene products for humans
Guide

   

Cosmetics and hygiene products for animals
Guide

   

Medical devices
Guide



 
 
 
 

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