CH-REP (Authorised Representative) Service
Required to represent a manufacturer located in another country
We SUPPORT YOU
Your uncomplicated way to continue supplying medical devices to Switzerland COMPLIANTLY
Recipe for success – we deal with Swissmedic, and you focus on your innovation and product(s),
Our advantages
How It Works
Easy 5 Steps Process
- Establish contact with us
- You will receive the contract and a list of the required information
- We will review and verify the information supplied by you
- We will advise on labeling
- Final check
Full Compliance
We dedicate us to maintain safe and compliant medical devices and IVDs market in SwitzerlandÂ
- registered with Swissmedic
- deep knowledge of relevant laws and regulations
- knowledgable Person Responsible for Regulatory Compliance
| CH-REP small | CH-REP medium | CH-REP large |
|---|---|---|
| CHF 99.-/month | CHF 199.-/month | upon request |
| Class I medical devices only | Class I medical devices only | All Classes of medical devices or IVDs |
| Up to 10 devices | 11 to 50 devices | 51 or more devices |
| Scope of services: - Provide labeling guidelines - Review compliance - Contact for Swissmedic - Fulfill vigilance and incident reporting requirements - Assistance with required registrations |
Scope of services: - Provide labeling guidelines - Review compliance - Contact for Swissmedic - Fulfill vigilance and incident reporting requirements - Assistance with required registrations |
Scope of services: - Provide labeling guidelines - Review compliance - Contact for Swissmedic - Fulfill vigilance and incident reporting requirements - Assistance with required registrations |
| Optional or on-demand services: CHF 199.-/hour |
Optional or on-demand services: CHF 199.-/hour |
Optional or on-demand services: CHF 199.-/hour |
| Setup fee: To Be Agreed / one time |
Setup fee: To Be Agreed / one time |
Setup fee: To Be Agreed / one time |
| Key terms of the contract: Cancelable with 3-months notice |
Key terms of the contract: Cancelable with 3-months notice |
Key terms of the contract: Cancelable with 3-months notice |
Transparent and Affordable Fees
You pay generally a fixed fee. Only in specific situations we apply our hourly rate to cover extra efforts.
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