Category: Switzerland AR Responsibilities

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 to the Medical Device Ordinance. Who needs to Appoint an AR? Any medical device manufacturer not based in Switzerland shall sell their products in the Swiss market only after a Switzerland based Authorized Representative is appointed. Where AR name has […]
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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 commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of […]
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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 drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at […]
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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 Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2. Which current Switzerland medical device regulations need to be followed by stakeholders? From May 26th, 2021, Stakeholders need to follow the revised Medical Devices Ordinance. (MedDO) and […]
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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 not updated the Mutual Recognition Agreement (MRA) No barrier free access to the EU internal market Swiss has been downgraded to the third country Swiss manufactures has stricter requirements when exporting their medical devices to the EU. The Swiss MedTech […]
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Switzerland Authorised Representative - www.omcmedical.com

Switzerland Authorised Representative

Switzerland Medical Device Regulations Medical devices are regulated by : Swiss Agency for Therapeutic Product Manufacturer Responsibility Ensuring medical device placed on the market is in accordance with the requirement of the medical device ordinance. Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR. Keep technical documentation, declaration of […]
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