Tag: Regulatory Country Submission

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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