Switzerland Product Registration & Certification
Important Notes
- Regulatory Mutual Recognition & Equivalence: Based on the EU-CH MRA, devices generally follow EU MDR/IVDR requirements with NB certification, but must be notified separately to Swissmedic.
- CH-REP Requirement: Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) responsible for registration, communication with Swissmedic, and post-market obligations.
- Labeling & Language: Labels must include CH-REP details, be in German, French, or Italian, and bear the Swiss Conformity Mark (alongside or instead of CE mark as applicable).
- UDI & Database Registration: Assign UDI per EU rules and submit information to the Swiss medical devices database (analogous to but separate from EUDAMED).
- Special Category Management: IVDs require particular attention; since 2022, high-risk IVDs must comply with Swiss rules analogous to EU IVDR.
- Payer Registration: For reimbursement, additional registration with the Federal Office of Public Health (FOPH) or health insurers is typically required.
Switzerlandecific Requirements
- EU-Aligned yet Independent System: Market access heavily relies on EU certification due to the MRA, but involves fully separate administrative and legal procedures.
- Post-EU Regulatory Evolution: Swiss regulations actively follow EU MDR/IVDR changes, creating an “equivalent but not synchronous” adaptation model; companies must monitor bilateral agreement updates.
- High-Value Niche Market: Leads in per capita healthcare spending, with high acceptance of premium and innovative products, but total market size is limited, concentrating competition in niches.
- Decentralized Payer & Procurement: The 26 cantons have high autonomy in procurement and reimbursement, requiring a strategy that combines federal rules with cantonal implementation.
- Multilingual & Cultural Nuance: Significant differences in business practices, clinical preferences, and communication styles exist across German, French, and Italian regions, necessitating精细化 local operations.
Medical Devices Registration
Regulatory Requirements
- CE Marking (Swiss MRA Recognition) or Swiss CHCG Marking
- Classification Management per Medical Devices Ordinance (MedDO) (Class I, IIa, IIb, III)
- Complete Technical Documentation and Clinical Evaluation Report
- Quality Management System Certificate (ISO 13485)
- Swiss Authorized Representative Appointment
- Swissmedic Registration (Class IIb, III products)
- Technical Documentation File
- Post-Market Surveillance Plan
- Unique Device Identification (UDI) Implementation
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Conformity Assessment Completion
- Swiss Representative Appointment
- Swissmedic Registration Submission
- Market Access Completion
Registration Timeline
8-18 months
Official Fees
CHF 3,000 - 40,000
Service Fees
$18,000 - $50,000
Regulatory System Overview
Swissmedic
Swiss Agency for Therapeutic Products
Responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and in vitro diagnostic devices. Operates as an independent regulatory authority under the Swiss Federal Office of Public Health.
BLV
Federal Food Safety and Veterinary Office
Responsible for safety regulation, market surveillance, and consumer protection of food, food supplements, and cosmetics, ensuring product safety and compliance
SECO
State Secretariat for Economic Affairs
Responsible for product quality and safety, technical standards, and market surveillance, implementing Switzerland-EU Mutual Recognition Agreement (MRA)
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to Swiss MedDO (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete technical documentation including clinical evaluation, performance verification, risk management
Conformity Assessment
Complete CE certification through EU Notified Body or Swiss CHCG certification
Swiss Representative Appointment
Appoint authorized representative in Switzerland responsible for regulatory compliance
Swissmedic Registration
Submit mandatory registration for Class IIb, III high-risk medical devices to Swissmedic
Cosmetics Registration
Regulatory Requirements
- Swiss Cosmetic Notification
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPS)
- Good Manufacturing Practice (ISO 22716)
- Swiss Official Language Labeling (German/French/Italian)
- Ingredient Safety Assessment
- Swiss Responsible Person Appointment
- Product Ingredient Inventory
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- Swiss Responsible Person Appointment
- Cosmetic Notification Submission
- Labeling Compliance Review
Registration Timeline
3-6 months
Official Fees
CHF 0 - 2,000
Service Fees
$6,000 - $15,000
Regulatory System Overview
Swissmedic
Swiss Agency for Therapeutic Products
Responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and in vitro diagnostic devices. Operates as an independent regulatory authority under the Swiss Federal Office of Public Health.
BLV
Federal Food Safety and Veterinary Office
Responsible for safety regulation, market surveillance, and consumer protection of food, food supplements, and cosmetics, ensuring product safety and compliance
SECO
State Secretariat for Economic Affairs
Responsible for product quality and safety, technical standards, and market surveillance, implementing Switzerland-EU Mutual Recognition Agreement (MRA)
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPS) by qualified safety assessor
PIF Preparation
Prepare complete product information file including all technical data
Swiss Responsible Person Appointment
Appoint responsible person in Switzerland for product compliance
Swiss Notification
Submit product information through Swiss cosmetic notification system
Multilingual Labeling
Ensure labeling complies with Swiss three official language requirements
Food Supplements Registration
Regulatory Requirements
- Swiss Food Safety Ordinance (LGV) Compliance
- Ingredient Compliance Assessment (Switzerland Permitted Ingredient Lists)
- Nutrition and Health Claims Compliance
- Swiss Official Language Labeling (German/French/Italian)
- Good Manufacturing Practice Certification
- Ingredient Specifications and Purity Proof
- Product Stability Data
- Swiss Importer Appointment
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Swiss Importer Appointment
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
3-6 months
Official Fees
CHF 800 - 3,000
Service Fees
$7,000 - $16,000
Regulatory System Overview
Swissmedic
Swiss Agency for Therapeutic Products
Responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and in vitro diagnostic devices. Operates as an independent regulatory authority under the Swiss Federal Office of Public Health.
BLV
Federal Food Safety and Veterinary Office
Responsible for safety regulation, market surveillance, and consumer protection of food, food supplements, and cosmetics, ensuring product safety and compliance
SECO
State Secretariat for Economic Affairs
Responsible for product quality and safety, technical standards, and market surveillance, implementing Switzerland-EU Mutual Recognition Agreement (MRA)
Food Supplements Registration Process
Ingredient Compliance Assessment
Evaluate all ingredients for compliance with Switzerland permitted ingredient lists
Technical Documentation Preparation
Prepare technical documents including safety evidence, quality specifications
Swiss Importer Appointment
Appoint importer in Switzerland responsible for product compliance
Multilingual Labeling Review
Ensure labeling complies with Swiss three official language regulations
Claims Compliance
Review all health claims for compliance with Swiss authorized lists