Category: Medical Device Registration

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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Romania Medical Device Registration

MEDICAL DEVICE REGISTRATION IN ROMANIA

How OMC Medical can assist you with the process Act as your Romanian AR    Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities.   Translate your documents to Romanian for submission. Regulatory Authority: National Agency for Medicines and Medical Devices of Romania  Link for MoH: https://www.anm.ro/en/  Local Listing or Registration: Yes, Local listing is required.  Local […]
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