New Registration Process for Economic Operators in Switzerland: Key Dates You Can’t Miss!
Exciting news for all manufacturers, authorized representatives, and importers in Switzerland! Swissmedic is rolling out a new registration system via the swissdamed Actors module starting August 2024. Here’s what you need to know:
📅 Key Dates:
🗓️ Until July 26, 2024: Last day to submit PDF forms for CHRN registration and modifications.
🗓️ August 2024: Launch of the swissdamed Actors module. All registrations will be exclusively through this platform.
🗓️ Early August 2024: Registered operators will receive next steps via their provided contact person.
🚨 What’s Changing?
🔒 Exclusive Registration in swissdamed: No more PDF forms after July 26, 2024. All processes will be conducted through the new module.
🔢 CHRN (Swiss Single Registration Number): Assigned once by Swissmedic, this unique number will identify economic operators in Switzerland.
👥 Who Does This Affect?
This change impacts all manufacturers, authorized representatives, and importers operating in Switzerland as per Art. 55 MedDO and Art. 48 IvDO. Ensure you register with Swissmedic and provide the required info within three months of introducing a device to the Swiss market.
📄 Application Requirements:
Proof of domicile in Switzerland (extract from the commercial register or certificate of residence).
This streamlined system aims to prevent delays in marketing compliant devices and ensures a steady supply in Switzerland.
Stay ahead and be prepared for swissdamed! 🚀
