Swiss Authorized Representative
for medical devices
CH REP
Swissmedic compliance
Swiss Authorized Representative
According to the Swiss Medical Devices Ordinance (MedDO, SR 812.213), non-Swiss manufacturers placing medical devices or in vitro diagnostics on the Swiss market must appoint a Swiss Authorized Representative, also known as CH-REP.
The CH-REP acts as the official legal representative of the foreign manufacturer in Switzerland. . This role includes supporting compliance with Swissmedic requirements, acting as the primary point of contact with the authorities and managing product registration in Swissdamed, the Swiss national database for medical devices.
ALTRION, based in Ticino, operates as a local CH-REP for medical devices and IVDs. The service supports regulatory alignment, proper labeling in the required Swiss languages, including German, French and Italian, and continuous compliance throughout the product life cycle.
CH-REP appointment and Swissdamed registration
ALTRION supports the formal CH-REP appointment for non-Swiss manufacturers placing medical devices or IVDs on the Swiss market. The service includes registration in Swissdamed for all device classes, including Class I, IIa, IIb, III and IVDs.
A correct CH-REP appointment is essential to ensure that the manufacturer has an official legal representative in Switzerland and that the required information is properly managed in the Swiss medical device regulatory system.
Labeling, IFU and multilingual compliance
Medical device labeling and Instructions for Use must be aligned with MedDO and MedDO-IVD language requirements. . ALTRION verifies labeling, IFU and multilingual documentation to support compliance with the Swiss regulatory framework.
This activity is particularly important for manufacturers entering the Swiss market, where documentation and product information must be clear, consistent and available in the required Swiss languages.. ALTRION helps ensure that the CH-REP information, labeling elements and user-facing documentation are properly reviewed before and after market placement.
Declaration of Conformity and technical documentation review
ALTRION reviews the Declaration of Conformity and supporting Technical Documentation to verify consistency with MDR and IVDR requirements and the regulatory evidence supporting the device. This review helps manufacturers ensure that the documentation used for Swiss market access is complete, coherent and aligned with applicable European and Swiss regulatory requirements.
The objective is to identify inconsistencies, documentation gaps and potential compliance issues, improving the overall quality and reliability of the regulatory file available for Swissmedic inspections, market surveillance activities and economic operator obligations.
Where documentation is incomplete, outdated or not yet available, ALTRION can also support the manufacturer in the preparation, remediation and maintenance of MDR and IVDR Technical Documentation. Depending on the project needs, our regulatory specialists can develop individual documentation elements or create a complete Technical Documentation package from the ground up.
Support may include:
- Declaration of Conformity preparation and review;
- General Safety and Performance Requirements (GSPR) compliance checklists;
- Risk Management documentation according to ISO 14971;
- Clinical Evaluation Reports (CER) and Performance Evaluation documentation;
- PMS, PMCF and PSUR documentation;
- Labeling, UDI and Instructions for Use (IFU) review;
- Regulatory gap assessments and remediation plans;
- Technical Documentation structure and compilation according to MDR/IVDR Annexes II and III.
Particular attention is given to Swiss-specific requirements, including CH-REP and importer obligations, Swiss labeling requirements, Swissdamed registration requirements and the practical expectations of Swissmedic. This allows manufacturers to establish a regulatory framework that supports both European and Swiss market access through a consistent and compliant documentation package.
Swissmedic communication and notifications
As CH-REP, ALTRION can support communication with Swissmedic on behalf of the manufacturer. This includes regulatory notifications, vigilance reporting and market surveillance follow-up where required.
Having a local representative able to manage communication with Swissmedic helps non-Swiss manufacturers maintain a clearer and more controlled regulatory process. ALTRION acts as a structured point of contact between the manufacturer and the Swiss authority.
Post-Market Surveillance and FSCA coordination
Swiss compliance continues after the device has been placed on the market. ALTRION supports the management of Post-Market Surveillance (PMS) activities and coordinates Field Safety Corrective Actions (FSCA) when required.
This support helps manufacturers monitor device performance, manage safety-related information and respond properly to post-market obligations in Switzerland. PMS and FSCA coordination are essential parts of maintaining compliance throughout the device life cycle.
Regulatory documentation archiving in Switzerland
ALTRION manages the archiving and maintenance of regulatory documentation in Switzerland, ensuring traceability and immediate availability for Swissmedic review.
Reliable documentation management is an important responsibility for manufacturers and their Swiss Authorized Representative. ALTRION helps ensure that the relevant records are securely maintained and can be made available when required by the Swiss authority.
Renewals, modifications and Swissdamed updates
ALTRION supports renewals, modifications and Swissdamed updates, including Basic UDI-DI and manufacturer data changes. This service helps manufacturers keep their Swiss regulatory data accurate and aligned with product or company updates over time.
Maintaining Swissdamed information is not a one-time activity. It requires continuous attention when products, manufacturers, documentation or regulatory details change. ALTRION supports these updates as part of ongoing CH-REP compliance.
Regulatory intelligence service
ALTRION can also provide an optional regulatory intelligence service with updates on Swissmedic guidance and EU-Swiss bilateral alignment.
This support helps manufacturers stay informed about regulatory developments that may affect Swiss market access, CH-REP obligations, documentation expectations or product life-cycle compliance.
FAQ about Swiss Authorized Representative for medical devices
What is a CH-REP for medical devices?
A CH-REP is the Swiss Authorized Representative appointed by a non-Swiss manufacturer to act as its official legal representative for medical devices or IVDs placed on the Swiss market.
Who needs a Swiss Authorized Representative?
Non-Swiss manufacturers placing medical devices or in vitro diagnostics on the Swiss market must appoint a Swiss Authorized Representative according to the Swiss Medical Devices Ordinance.
What does a CH-REP do?
A CH-REP supports compliance with Swissmedic requirements, acts as the primary point of contact with Swiss authorities, manages Swissdamed registration and supports post-market obligations such as vigilance and PMS activities.
Does labeling need to be adapted for Switzerland?
Yes. Labeling, Instructions for Use and relevant product documentation must comply with MedDO and MedDO-IVD language requirements. ALTRION supports proper labeling in the required Swiss languages.
Can ALTRION support Swissdamed updates?
Yes. ALTRION supports Swissdamed registration and updates, including renewals, modifications, Basic UDI-DI and manufacturer data changes.
Why choose ALTRION
ALTRION is a registered Swiss legal entity located in Ticino, ensuring official local presence and legal standing under MedDO.. Its multilingual regulatory team is fluent in Italian, English, German and French, supporting proper communication and document review in all Swiss official languages. ALTRION also brings extensive experience in EU-Swiss regulatory alignment, MDR-to-MedDO transition and adaptation to Swissdamed data requirements.. Through efficient and transparent communication with Swissmedic and with the manufacturer’s EU-REP, ALTRION helps streamline submissions and regulatory follow-up.. The service is supported by a secure document management system compliant with ISO 13485 and GDPR requirements, and is part of a global representation network covering EU (EU-REP), UK (UKRP) and US FDA Agent services.
Can ALTRION act as Swiss Importer?
Yes. In addition to CH-REP services, ALTRION can act as the Swiss Importer for medical devices and IVDs originating from outside Switzerland. Under Swiss medical device legislation, the importer is not a formally designated regulatory role in the same way as the CH-REP. An entity becomes the importer by introducing products from abroad and making them available on the Swiss market. This may include supplying a distributor, healthcare institution, clinic, physician or end user located in Switzerland.
As part of this service, ALTRION manages the importation process through qualified logistics and customs partners, ensuring that products are lawfully introduced into Switzerland and delivered directly to the customer identified by the manufacturer.
ALTRION does not provide warehousing or stockholding services. Products are shipped directly from the foreign manufacturer to the identified Swiss recipient, while ALTRION manages the commercial import transaction and the related customs and administrative requirements.
In practice, ALTRION purchases the products from the foreign manufacturer and resells them to the Swiss economic operator identified by the manufacturer. A service margin, typically around 15%, is applied to cover transportation, customs clearance, importation costs and administrative management activities.
This model allows manufacturers without a Swiss legal entity to access the Swiss market efficiently while ensuring compliance with Swiss importer obligations.
This model allows manufacturers without a Swiss legal entity to access the Swiss market efficiently while ensuring compliance with Swiss importer obligations.
Deliverables
ALTRION provides the key documentation and regulatory outputs needed to support CH-REP appointment, Swissdamed registration and ongoing Swiss market compliance.
- CH-REP Designation Letter and Service Agreement compliant with Article 51 MedDO requirements.
- Confirmation of Swissdamed registration, including manufacturer and device listing.
- Contact details for labeling and documentation, as required by Annex IX MedDO.
- Annual PMS and vigilance summary report, including Swissmedic communications log.
- Ongoing regulatory support for product renewals and data updates in Swissdamed.
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