CH-REP vs Swiss importer vs distributor: what's the difference (and can one company do multiple roles)?

## CH-REP vs Swiss Importer vs Distributor: What's the Difference? Understanding the distinction between CH-REP, importer, and distributor roles is critical for compliance. These are **separate legal roles** with different obligations, though a single company can sometimes fulfill multiple roles. ### The Three Roles #### 1. **CH-REP (Swiss Authorized Representative)** - **Regulatory role** - Represents the manufacturer for formal and safety-related issues - **Required for**: Non-Swiss manufacturers placing devices on the Swiss market - **Key responsibilities**: - Hold or ensure access to technical documentation - Ensure vigilance reporting to Swissmedic - Cooperate with Swissmedic on regulatory matters - Maintain written mandate with manufacturer #### 2. **Swiss Importer** - **Supply chain role** - Company that places a device from outside Switzerland on the Swiss market - **Required for**: Any device imported into Switzerland - **Key responsibilities**: - Verify device has appropriate markings and documentation - Verify manufacturer and CH-REP (if applicable) are identified - Maintain complaint registers - Cooperate with Swissmedic on market surveillance - Register for CHRN #### 3. **Distributor** - **Commercial role** - Company that makes a device available on the market (but doesn't import it) - **Required for**: Companies selling devices already on the Swiss market - **Key responsibilities**: - Verify device has appropriate markings - Verify device is registered if required - Maintain complaint registers - Not distribute devices that don't comply - **Does NOT need to register for CHRN** ### Key Distinctions According to Swissmedic's obligations sheet, these roles have **distinct responsibilities**: | Aspect | CH-REP | Importer | Distributor | |--------|--------|----------|-------------| | **Primary Role** | Regulatory | Supply Chain | Commercial | | **CHRN Required?** | Yes | Yes | No | | **Technical Documentation** | Must hold/ensure access | Must verify availability | Must verify compliance | | **Vigilance Reporting** | Responsible for ensuring reports | Must report incidents | Must report incidents | | **Labeling Requirements** | Name/address on label | Name/address on label (optional) | Verify labeling present | ### Can One Company Do Multiple Roles? **Yes, but with important caveats:** #### CH-REP + Importer A single company **can** be both CH-REP and importer, but: - Must meet **both sets of obligations** - May need to register **separately for each role** - May receive **two separate CHRNs** (one for each role) - Must clearly distinguish the roles in operations - Must comply with all requirements for both roles #### Importer + Distributor A company can be both importer and distributor, but must meet obligations for both roles. #### CH-REP + Distributor A CH-REP can also act as a distributor, but the regulatory role (CH-REP) is separate from the commercial role (distributor). ### Important Practical Implications #### 1. **CHRN Registration** - **CH-REP**: Must register for CHRN - **Importer**: Must register for CHRN - **Distributor**: **No CHRN registration required** (Swissmedic explicitly states this) #### 2. **Labeling Requirements** - **Manufacturer**: Must always be indicated on label - **CH-REP**: Must be indicated on label (for non-Swiss manufacturers) - **Importer**: Can be indicated on device/packaging/accompanying document under Swiss rules - **Distributor**: No specific labeling requirement #### 3. **Documentation Access** - **CH-REP**: Must hold or ensure 7-day access to technical documentation - **Importer**: Must verify documentation is available - **Distributor**: Must verify device compliance #### 4. **Vigilance Reporting** - **CH-REP**: Responsible for ensuring reports are sent to Swissmedic - **Importer**: Must report serious incidents - **Distributor**: Must report serious incidents ### Common Scenarios #### Scenario 1: EU Manufacturer → Swiss Importer → Swiss Distributor - **Manufacturer**: EU-based, needs CH-REP - **Importer**: Swiss company, imports from EU, needs CHRN - **Distributor**: Swiss company, distributes imported devices, no CHRN needed #### Scenario 2: US Manufacturer → Swiss CH-REP (who also imports) - **Manufacturer**: US-based, needs CH-REP - **CH-REP/Importer**: Swiss company serving both roles, needs CHRN for both roles (may get two CHRNs) #### Scenario 3: Swiss Manufacturer - **Manufacturer**: Swiss-based, no CH-REP needed, but needs CHRN as manufacturer ### Best Practices 1. **Clarify Roles Early** - Determine which roles each party will play 2. **Document Responsibilities** - Clearly define obligations in contracts 3. **Register Appropriately** - Ensure all required parties register for CHRN 4. **Maintain Separation** - If one company serves multiple roles, maintain clear operational separation 5. **Regular Review** - Periodically review role assignments as your business evolves ### Red Flags - ⚠️ Company claiming to be "CH-REP" but not registered for CHRN - ⚠️ Distributor claiming they need CHRN registration - ⚠️ Unclear division of responsibilities between roles - ⚠️ Missing written mandate for CH-REP relationship ### Next Steps 1. **[Compare Swiss CH-REP providers & request quotes](https://cruxi.ai/regulatory-directories/ch_rep)** - Use our directory to find and compare qualified CH-REP providers --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Swissmedic - Economic Operator Roles](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)