As a CH-REP, we facilitate
your market access in Switzerland.
Our high level of compliance and regulatory knowledge was confirmed by Swissmedic.
According to the revised Swiss Medical Devices Ordinance (MedDO) and the new In-Vitro Diagnostics Ordinance (IvDO), manufacturers based outside Switzerland need a Swiss Authorised Representative (CH-REP) to sell their products in Switzerland. A detailed explanation can be found on our blog.
Decomplix offers the CH-REP service to medical device and in-vitro diagnostic manufacturers of all types and sizes from all around the globe.
100+ customers trust Decomplix
Our customers confirm: We offer a fast and smooth process.
- Fees based on number of GMDN codes or TechDocs per device class
- CH-REP contract signing
- Manufacturer’s updates to QMS and CH-REP labeling
- Verification of key TechDoc files and QMS SOPs
- Verification statement by Decomplix
- Start and maintain Swiss market access
- Communications with Swissmedic
- Ensuring Vigilance reporting
- Regulatory updates
Decomplix’ CH-REP service includes:
Ensuring compliance with registration requirements in Switzerland under the MedDO and IvDO.
Verifying compliance of CE marking documentation and key QMS processes with MedDO/IvDO requirements.
Verifying that device labeling fulfills the requirements in Switzerland.
Communications with the Swiss competent authority, Swissmedic, as well as with all relevant economic operators.
Cooperating with Swissmedic on preventive and corrective actions during audits and/or requests for product samples.
Ensuring that copies of the technical documentation, declarations of conformity and, if applicable, the relevant notified body certificates are made available to the Swiss competent authority (Swissmedic) upon request.
Ensuring the reporting of serious incidents occurring in Switzerland, Field Safety Corrective Actions (FSCA) implemented in Switzerland, and trend reports to Swissmedic (Vigilance reporting).
In addition, maintaining our customers informed on relevant regulatory updates.
Why Decomplix as your partner
100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Decomplix’ high level of compliance and regulatory knowledge was confirmed by a successful Swissmedic inspection. Decomplix is one of the few inspected CH-REPs without any non-conformities.
Decomplix operates under a ISO 13485 certified quality management system.
As a boutique regulatory consultancy, Decomplix always offers you high quality in a short time and with personal support from our experts.
Decomplix stands by as a coach in compliance matters and as the customer’s close contact to Swiss authorities.