Switzerland Medical Device Registration
Swiss Agency for Therapeutic Products (Swissmedic) approval timelines and requirements
Switzerland Medical Device Registration Overview
Switzerland medical device registration through Swissmedic typically takes 3-5 months for Class I devices. The official Swissmedic target is 2-4 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Switzerland uses a 4-class (I, IIa, IIb, III) - EU MDR aligned risk-based classification system. Foreign manufacturers must appoint a Swiss Authorized Representative (CH-REP) to register devices in Switzerland. Registration is valid for 5 years (aligned with CE certificate).
Switzerland uses a 4-class (I, IIa, IIb, III) - EU MDR aligned risk-based classification system.
Class I
Self-certification
Accelerated with: EU CE Mark (full recognition until 2028)
• EU CE Mark fully recognized during transition period
Class IIa
Conformity Assessment
Accelerated with: EU CE Mark (immediate access)
• CH-REP required for non-Swiss manufacturers
Class IIb
Enhanced Conformity Assessment
Accelerated with: EU CE Mark (immediate access)
• Clinical evaluation required
Class III
Full Assessment
Accelerated with: EU CE Mark (immediate access)
• Clinical data typically required
EU CE Mark Recognition
Full recognition of EU CE marked devices until 2028
MRA with EU
Mutual Recognition Agreement with EU (resumed 2024)
Existing approvals from other regulatory authorities can accelerate your Switzerland registration.
- Swiss Authorized Representative (CH-REP) for foreign manufacturers
- EU MDR technical documentation
- Swiss specific labeling requirements
- Swissmedic registration
5 years (aligned with CE certificate)
Switzerland Medical Device Registration Process
Step-by-step Swissmedic registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Swissmedic. Appoint a Swiss Authorized Representative (CH-REP).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Swissmedic including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksSwissmedic reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
2-4 monthsIn-depth technical assessment of device safety and performance. Swissmedic may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Swissmedic issues Switzerland market authorization certificate.
Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.