What is a CHRN, who needs it, and how fast/costly is registration?

## What is a CHRN, Who Needs It, and How Fast/Costly Is Registration? A **CHRN (Swiss Single Registration Number)** is Swissmedic's unique identifier for certain economic operators in the Swiss medical device market. Understanding who needs it, the timeline, and costs is essential for market entry planning. ### What is CHRN? The CHRN is used for **registering economic operators** (not products). It's similar to the EU's Single Registration Number (SRN) but specific to Switzerland. Each registered economic operator receives a unique CHRN that must be used in communications with Swissmedic. ### Who Needs CHRN? According to Swissmedic, the following economic operators must register for CHRN: 1. **Swiss manufacturers** - Manufacturers established in Switzerland 2. **Authorized representatives (CH-REPs)** - All CH-REPs must register 3. **Importers** - Companies importing devices into Switzerland 4. **Systems/procedure pack manufacturers** - Companies assembling systems or procedure packs **Important**: Distributors do **not** need to register for CHRN. Swissmedic explicitly states there is no requirement for distributors to register. ### Registration Deadline Economic operators must register within **3 months of first placing a device on the Swiss market**. This means: - If you start selling devices in Switzerland on January 1st, you must register by April 1st - The clock starts from your first commercial placement, not from when you engage a CH-REP - Late registration can result in regulatory non-compliance ### How to Apply Since **August 6, 2024**, all applications, changes, and mandate notifications go through the **Swissdamed portal** (Swiss Database on Medical Devices). The previous paper-based process has been replaced with this digital system. **Application Process:** 1. Access the Swissdamed portal at [www.swissdamed.ch](https://www.swissdamed.ch) 2. Create an account for your organization 3. Complete the registration form with required information 4. Submit supporting documentation 5. Pay the registration fee 6. Wait for Swissmedic processing ### Processing Time Swissmedic states that processing takes **up to 30 days in principle**. However, actual timelines may vary based on: - Completeness of application - Volume of applications at Swissmedic - Complexity of your organization structure - Whether you're registering multiple roles (e.g., both CH-REP and importer) **Best Practice**: Apply well before your 3-month deadline to account for potential delays. ### Registration Fee Swissmedic lists a **flat fee of CHF 200** for issuing a CHRN. This is a one-time fee per registration, though there may be additional fees for: - Changes to registration information - Renewals (if applicable in the future) - Additional roles (if registering as both CH-REP and importer, you may need separate registrations) ### Key Considerations 1. **Multiple Roles**: If a single company serves as both CH-REP and importer, they may receive **two separate CHRNs**—one for each role. Each role must meet its respective obligations. 2. **Updates**: Any changes to your registration information (address, contact details, etc.) must be updated in Swissdamed promptly. 3. **Mandate Notifications**: When you engage a CH-REP, the mandate must be notified to Swissmedic through Swissdamed. 4. **Documentation**: Keep records of your CHRN registration and any correspondence with Swissmedic. ### Practical Tips - **Start Early**: Don't wait until the last minute—begin the registration process as soon as you know you'll be placing devices on the market - **Prepare Documentation**: Have all required company information, addresses, and contact details ready - **Budget Accordingly**: Include the CHF 200 fee in your market entry budget - **Track Deadlines**: Set calendar reminders for your 3-month registration deadline ### 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 - CHRN Registration](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html) - [Swissdamed Portal](https://www.swissdamed.ch)