SWEDEN ----------------------------------------------------------------------------------------------- Medical Products Agency Socialstyrelsen Codes of Statutes Dossier Requirements for Type I Variations Fees Forms and Format Notice to Applicants Summary of Products Characteristics (SPC) National Board of Health and Welfare Medical Devices - CE marking Acts and Regulations CE Marking Incident Report - Initial Incident Information from EU Commission New Rules for Medical Devices Organisation and Contacts Vigilance System Standardiseringen i Sverige (SIS)