CH-REP & CH-Importer Service

Supplying Medical Devices

To Switzerland?

Are You Compliant?

New Legal Requirements

Major revision of medical devices law in Switzerland

The new Swiss regulations related to medical devices and in vitro diagnostics establish two main types of economic operators:

With effect from 26 May 2021, the Mutual Recognition Agreement with the EU was terminated. Switzerland has enacted its own Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO).

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.

CH-REP - Swiss Representative

The CH-REP (Swiss Representative) acts as a link between non-Swiss manufacturers of medical devices and in vitro

diagnostics and the Swiss authorities. A CH-REP is a contact person based in Switzerland who ensures compliance with

Swiss laws. Without a CH-REP, a non-Swiss manufacturer of medical devices and in vitro diagnostics is not in compliance

and is not allowed to sell its products in the Swiss market.

Icon showing a group of people – symbolizing the representation of a foreign manufacturer in Switzerland.

Swiss flag icon – indicating the company's location in Switzerland for regulatory compliance.

Handshake infront of building – representing expertise as a Person Responsible for Regulatory Compliance (PRRC) for medical devices and in vitro diagnostics

Clipboard with a checkmark – symbolizing the verification of a manufacturer’s registration obligations.

Document with a pen – representing the registration of complaints, non-compliant products, product recalls, and withdrawals.

Document with an exclamation mark – symbolizing the reporting of serious incidents and corrective measures

Required to represent a manufacturer from another country

Based in Switzerland

Possesses the necessary expertise in the field of medical devices (Person Responsible for Regulatory Compliance), in vitro diagnostics

Checks the manufacturer's registration obligations regarding the products

Registers complaints, non-compliant products, recalls, and withdrawals

Reports serious incidents and corrective measures

Checklist document icon – indicating official registration with Swissmedic and an individual Swiss registration number (CHRN).

Hand holding a gear – symbolizing responsibility for formal and safety-related matters

Hand holding a checklist – representing the review of declarations of conformity, technical documentation, and conformity assessment procedures.

Speech bubble with an exclamation mark – symbolizing the redirection of complaints and reports of suspected incidents.

Handshake with a globe – representing cooperation with Swissmedic on preventive or corrective actions

Registered with Swissmedic and has a Swiss

individual registration number (CHRN)

Responsible for formal and safety-related matters

Reviews declarations of conformity, technical documentation, and conformity assessment procedures

Redirects complaints and reports of suspected incidents

Cooperates with Swissmedic on all preventive or corrective actions

CH-REP Info & Price List

Our transparent and cost-effective pricing structure.

CH-Importer

The import of medical devices and in vitro diagnostics into Switzerland is only allowed for companies registered with

Swissmedic. A non-Swiss manufacturer or distributor cannot register as an importer of medical devices and in vitro

diagnostics. Therefore, they require a CH-Importer if they intend to deliver these products to end customers in

Switzerland. This task can also be undertaken by a Swiss distributor who imports the medical devices. However,

registration as a CH-Importer with Swissmedic is a prerequisite.

Globe with connected people – representing the requirement to act as a representative for foreign manufacturers bringing medical devices or in vitro diagnostics to the Swiss market.

Handshake with a globe – symbolizing cooperation with manufacturers, authorized representatives, notified bodies, and relevant authorities.

Clipboard with a pen – representing the registration of complaints, non-compliant products, product recalls, and withdrawals.

Required to represent anyone bringing a medical device/in vitro diagnostics from a foreign country to the Swiss market

Registered with Swissmedic and has an individual Swiss

registration number (CHRN)

Cooperates with the manufacturer, the authorized representative, the notified body, and the relevant authorities

Registers complaints, non-compliant products,

recalls, and withdrawals

Speech bubble with an exclamation mark – symbolizing the redirection of complaints and suspected incident reports

Shield with a checkmark – representing the verification of conformity with the Medical Devices Ordinance (MedDO) or In Vitro Diagnostics Ordinance (IvDO).

Handshake with action lines – symbolizing support for the implementation of corrective actions, including recalls.

Redirects complaints and reports of suspected

incidents

Verifies conformity with the Medical Devices

Ordinance (MedDO) or In Vitro Diagnostics

Ordinance (IvDO)

Supports the implementation of corrective actions (including recalls)

Based in Switzerland

CH-Importer Info & Price List

Our transparent and cost-effective pricing structure.

Interested in Our Services as a CH-Rep or CH-Importer?

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