Our team of experts has extensive experience in the field of medical device and in vitro
diagnostics registration and quality assurance, as well as legal representation for non-Swiss
companies within Switzerland. We are registered with Swissmedic and hold certifications as both
a CH-REP (Authorized Representative) and a CH-Importer.
Motivated and dedicated to your success
Pursuing goal-oriented approach for all of our mandates
Eager to work with small and
medium companies
Always acting in full adherence to
Swiss laws and regulations
Striving to maintain the highest level of compliance
The company that knows!
As your trusted partner, we take on the legal representation as CH-REP and/or CH Importer of your
company in Switzerland, ensuring that you meet all regulatory requirements. Our customized
solutions and comprehensive expertise allow you to focus on your core business
while we take care of all regulatory aspects.
Discover the possibilities of our exceptional services! If you are interested in what
we have to offer, do not hesitate to get in touch.
Additional Information:
Switzerland enforces strict regulatory requirements for medical devices and in vitro diagnostics (IVDs). If you are a non-Swiss manufacturer or distributor looking to place your products on the Swiss market, you must appoint a CH-REP (Swiss Authorized Representative) and, in many cases, a CH-Importer to ensure full compliance with the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Ordinance (IvDO). Without these key compliance partners, medical devices and IVDs cannot legally be sold in Switzerland.
What is a CH-REP?
A CH-REP serves as the official representative for non-Swiss medical device manufacturers, acting as the primary contact for Swissmedic, overseeing regulatory compliance, and maintaining technical documentation. The CH-REP is responsible for ensuring post-market surveillance, vigilance reporting, and regulatory updates. Choosing an experienced CH-REP is crucial for ensuring smooth operations and preventing regulatory obstacles that could disrupt market access.
What is a CH-Importer?
A CH-Importer plays a critical role in ensuring that imported medical devices and IVDs comply with Swiss regulations. This includes verifying labeling and language requirements, registering products with Swissmedic, and ensuring all documentation is in order before the products reach the market. Without a designated CH-Importer, manufacturers and distributors risk compliance failures, shipment delays, and potential penalties.
Who Checks Compliance?
Both the CH-REP and CH-Importer have compliance responsibilities. The CH-Importer must verify that all imported products meet regulatory requirements, including correct labeling, language, and registration with Swissmedic. Meanwhile, the CH-REP ensures that the manufacturer maintains technical documentation, conducts post-market surveillance, and follows regulatory updates. Swissmedic can conduct audits, and non-compliance may lead to product recalls, fines, or market bans. Choosing a trusted regulatory partner is essential to avoid legal risks and ensure smooth market access.
Why Choose Our CH-REP & CH-Importer Services?
We offer comprehensive, reliable, and expert-driven CH-REP and CH-Importer services to ensure hassle-free market entry and ongoing compliance. Our team has extensive experience in Swiss regulatory affairs, helping you navigate legal complexities with ease.
With our support, you can focus on growing your business while we handle regulatory requirements, compliance checks, and Swissmedic interactions on your behalf.
Stay Informed with the CHREP.me Blog
Looking for the latest updates on Swiss medical device regulations? The CHREP.me Blog is your go-to resource for news, insights, and expert analysis on CH-REP and CH-Importer requirements. Stay ahead of regulatory changes, compliance updates, and best practices to ensure smooth market access in Switzerland.
Contact us today to ensure your medical devices meet all Swiss requirements and gain seamless access to the Swiss market!
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