We provide regulatory services (MEDICAL DEVICES / In Vitro Diagnostics)
Supplying medical devices to Switzerland?
Are you compliant?
NEW REGULATORY LANDSCAPE
Major revision of medical devices law in Switzerland
In a nutshell: Switzerland is now a “third country”, and any foreign manufacturer or distributor placing medical devices or IVDs onto the Swiss market needs to be represented by a CH-REP and/or CH Importer.
New Swiss regulations related to medical devices and IVDs establish two main types of economic operators:
The CH-REP (Authorised Representative) is a liaison between non-Swiss manufacturers of medical devices and IVDs and the Swiss authorities. A CH-REP is a Swiss-domiciled point of contact that ensures Swiss laws’ compliance. Without a CH-REP, a non-Swiss manufacturer of medical devices and IVDs is non-compliant and cannot sell his products on the Swiss market.
The CH Importer is a liaison between a non-Swiss distributor of medical devices and IVDs and the Swiss authorities. A CH Importer is a Swiss-domiciled point of contact that ensures Swiss laws’ compliance. Without a CH Importer, a non-Swiss distributor is non-compliant and cannot import any non-Swiss medical devices and IVDs into Switzerland.
WHAT CAN WE DO FOR YOU
CH-REP & CH Importer Services made easy
Our experts will help you to significantly reduce the regulatory burden and corresponding financial costs
CH-REP (Authorised Representative) Service
- Required to represent a manufacturer located in another country
- Registered with Swissmedic and has the Swiss Single Registration Number (CHRN)
- Domiciled in Switzerland
- Responsibility for the formal and safety-related issues
- Possesses the requisite expertise in the field of medical devices (Person Responsible for Regulatory Compliance)
- Checks declarations of conformity/technical documentation/conformity assessment procedures
- Checks the manufacturer's registration obligations regarding devices
- Reports serious incidents and safety corrective actions
- Forwards complaints and reports about suspected incidents
- Registers complaints, non-conforming devices, recalls and withdrawals
- Cooperates with Swissmedic in all preventive or corrective actions
CH Importer Service
- Required to represent anyone who places a device from a foreign country on the Swiss market
- Registered with Swissmedic and has the Swiss Single Registration Number (CHRN)
- Domiciled in Switzerland
- Verifies compliance with MedDO or IvDO
- Cooperates with the manufacturer, authorised representative, designated body and competent authorities
- Forwards complaints and reports about suspected incidents​
- Registers complaints, non-conforming devices, recalls and withdrawals
- Assists with the implementation of corrective actions (including recalls)
We will answer any of your questions.
Please click the question in order to show the corresponding answer.
Unfortunately, no. The regulatory landscape has changed, and you should take additional steps to remain compliant. We’ll make sure to minimize the administrative and financial burden.
It is possible and usually done by large manufacturers.
Please note that it requires establishing own legal person in Switzerland and has relatively high (estimated as 15k+ CHF/year minimum) associated costs (e.g., office rent, legal/accounting services, employment of PRRC (Person Responsible for Regulatory Compliance) person).
Absolutely yes.
Deadlines for manufacturers established in an EU/EEA state or which have an authorised representative in an EU/EEA
MDD/AIMDD and MDR devices:Â
- Classes III, IIb implantable and AIMD: 31 December 2021Â
- Non-implantable Class IIb, Class IIa: 31 March 2022Â
- Class I: 31 July 2022Â
- Systems and procedure packs: 31 July 2022Â
IVDD and IVDR devices:Â
- Class D: 31 December 2022Â
- Classes C and B: 31 March 2023Â
- Class A: 31 July 2023Â
All other foreign manufacturers are required to appoint a Swiss authorised representative with effect from 26 May 2021 (for MDD/AIMDD and MDR devices) or from 26 May 2022 (for IVDD and IVDR devices).Â
Despite its small population, Switzerland accounts for ca. 4.5% of the €140 billions European medical device market (see MedTech Europe publication).
And we have created an easy 5 steps process to get your medical devices and IVDs compliant with the Swiss regulations.
- 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
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