Your Fast Track to a CH-Importer
Your Fast Track to a CH-Importer
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With the introduction of the Medical Device Ordinance (MedDO) and the Ordinance on In Vitro Diagnostics (IvDO) in 2021, strict regulatory requirements now apply to companies importing medical devices and IVDs into Switzerland. Any Swiss-based distributor that places such products from abroad onto the Swiss market is considered a CH-Importer and must ensure full compliance with Swiss regulations.
Without sufficient regulatory expertise, fulfilling CH-Importer obligations can be complex and time-consuming. Understanding the role, responsibilities, and legal requirements of a CH-Importer is essential to avoid compliance risks and ensure a smooth market entry.
Our simple and fast 5-step approach
Our simple and fast 5-step approach
After completing these five simple steps, you’ll be ready to sell your products in the Swiss market.
Reach out to us via email or phone.
You will receive the contract and a checklist of the required information.
We will review and verify the information you provide. If you are already MDR/IVDR compliant, this process will be quick and straightforward.
We will guide you through all the necessary steps, with a primary focus on documentation.
Typically, within 10 days after you have
provided us with the information.
50+
Distributors already trust us for their CH-Importer and CH-REP services.
CH-Importer Price List
CH-Importer Price List
Experience the simplicity, transparency, and cost-effectiveness of our processes and
pricing structure. Our CH-Importer package includes services that are typically more
than sufficient for our customers to enter the Swiss market. Additional expenses, which
are rarely required, will be calculated based on our hourly rate.
CH-Importer
CH-Importer
CHF 499.-/month
All Classes of medical devices or IVDs
Unlimited devices
Scope of services:
→ Review compliance
→ Contact for Swissmedic
→ Full vigilance and incident reporting requirements
→ NEW: Compliance Seal & Certificate for your website [view sample]
Optional or on-demand services:
CHF 199.-/hour
Setup Fee:
CHF 999.-/One time
Key terms of contract:
Cancelable with 3-month notice
I want to know more about your CH-Importer services!
I want to know more about your CH-Importer services!
Do not hesitate to contact our experts today.
Additional Information:
Switzerland’s medical device regulations require non-Swiss manufacturers to appoint a CH-Importer before placing their products on the Swiss market. A CH-Importer is responsible for ensuring that medical devices and in vitro diagnostics (IVDs) comply with Swiss law, including proper labeling, documentation, and post-market surveillance.
Since the termination of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, Switzerland now operates as a third country, meaning that medical device manufacturers from the EU and other regions must meet additional regulatory requirements. A CH-Importer, based in Switzerland, acts as the official importer of record and ensures compliance with the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Ordinance (IvDO).
Choosing a reliable CH-Importer is crucial for seamless market entry and avoiding regulatory hurdles. The CH-Importer is responsible for registering devices with Swissmedic, verifying compliance with Swiss labeling and language requirements, and ensuring proper vigilance reporting in case of incidents. Without an authorized CH-Importer, non-Swiss manufacturers cannot legally sell their medical devices in Switzerland.
If you are looking for a trusted CH-Importer to help you navigate Swiss regulations, ensure compliance, and facilitate a smooth entry into the market, we are here to support you. Contact us today to learn more about our CH-Importer services and how we can assist you in bringing your medical devices to Switzerland. Fast track.
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