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Labelling Requirements – Swiss Authorized Representative - www.omcmedical.com

Labelling Requirements – Swiss Authorized Representative

Who is a CH-REP? Swiss Authorized Representatives shall be referred to as CH-REP in accordance…
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Romania Medical Device Registration

MEDICAL DEVICE REGISTRATION IN ROMANIA

How OMC Medical can assist you with the process Act as your Romanian AR   …
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Swiss Manufacturer Obligations - www.omcmedical.com

Swiss Manufacturer Obligations

1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use…
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Switzerland AR Responsibilities - www.omcmedical.com

Switzerland AR Responsibilities

Obligations of the Swiss Authorised Representative 1. Verify the DoC and technical documentation have been…
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Swiss Regulation QA WHITE PAPER - www.omcmedical.com

Swiss Regulation QA WHITE PAPER

MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in…
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Switzerland Medical Device Regulations - www.omcmedical.com

Switzerland Medical Device Regulations

Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has…
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