Medical Device Registration in Hungary
General information for EU member states without any additional local domestic requirements:
As a member state of the European Union, medical devices and IVDs are regulated according to the relevant EU Directives:
- The Medical Device Directive 93/42 EEC
- The In Vitro Device Directive 98/79/EC
- The Active Implantable Medical Device Directive 90/385/EEC
Devices that have a CE-Mark under any one of these directives do not require additional registration or regulatory processes to be marketed in that country.
As of 2012, Arazy Group now offers our new service, LICENSALE.COM™. This unique, cloud-based application provides you, the medical or IVD device manufacturer, with a comprehensive service that results in the successful registration of your product in the EU and ownership of the registration license through your company.
Once you register in the EU through LICENSALE.COM™, a global compliance profile is generated that easily facilitates the registration of your product in more than 80 countries around the world. LICENSALE.COM™ creates a foundation that makes registration simpler, faster, and more cost-effective than any alternative available today.
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