Your Trusted Partner in Switzerland

The Swiss market demands the best—and rewards them. We ensure your products meet rigorous Swiss standards, unlocking a market renowned for discerning consumers and premium prices.

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Swiss Authorised Representative

All non-Swiss manufacturers must designate a Swiss Authorised Representative (CH REP) to sell their medical devices in Switzerland.

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Product registration

Depending on the applicable legislation, we perform a product registration or notification to access the EU, UK, and Swiss market.

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Technical documentation

A compliant technical file is a key aspect when aiming to obtain the CE marking for the European markets.

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Consultancy, Legal and Training

For all manufacturers and brand-owners, we offer consultancy services to guide you through the applicable regulatory requirements.

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Switzerland

Consequences of non-compliance

Companies that fail to comply with Swiss regulations risk serious consequences. Contact Obelis today for expert guidance and support with your regulatory compliance needs.

Significant fines are levied against non-compliance, with amounts determined by the severity of the violation and potential harm caused.

Lawsuits or administrative proceedings for damages, unfair competition, or other regulatory violations.

Swiss consumers and businesses value ethical behaviour and adherence to regulations. Non-compliance can damage a company’s reputation and trustworthiness.

Depending on the industry, violations can lead to suspension of activities, revocation of permits, or product recalls, disrupting operations.

Non-compliance with Swiss regulations can also create barriers to doing business in the EU or other international markets.

Partner with us

By partnering with us you get

Thorough Compliance

We meticulously guide you through the complex regulatory landscape in Switzerland, ensuring your products meet all requirements.

Risk Mitigation

We identify and address potential compliance issues early, protecting your investment and minimising risk.

Peace of Mind

Focus on growing your business while we handle the regulatory complexities, giving you the confidence to launch successfully in Switzerland.

We register your product within 3 working days.

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