Medical Device & Cosmetic Product Compliance
We make your regulatory compliance our mission.
WHY CHOOSE US
We are attentive to your specific needs while partnering to safeguard access to market.
Are you a manufacturer in Israel wishing to penetrate the EU, UK, Swiss or USA markets? Obelis Group is here to assist you.
We will review your technical documentation, upload your products to the relevant registration portals and assume the role of EU Authorized/Legal Representative, EU/UK Responsible Person and/or US Agent to ensure your products can safely enter the market without incidents or being blocked at customs.
MoCRA establishes that facilities based outside the United States must have an in-country representative: a US Agent.
EU Authorized Representative
You can appoint us as your EU Authorised Representative (EC REP) for different products, such as medical devices.
Consultancy
For all manufacturers and brand-owners, we offer consultancy services to guide you through the applicable regulatory requirements.
Product Registration
Depending on the applicable legislation, we perform a product registration or notification to access the EU, UK, and Swiss market.
GET YOUR FREE CONSULTATION
Obelis Group
Boulevard Brand Whitlock 30,
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
sales@obelis.net
© Obelis Group 2025
EU Responsible Person
To sell cosmetics in the European Union, brand-owners must appoint an EU Responsible Person (RP).
Swiss Authorized Representative
All non-Swiss manufacturers must designate a Swiss Authorised Representative (CH REP) to sell their medical devices in Switzerland.
US Agent
EU, UK & USA registration & market access
UK Responsible Person
You can appoint us as your UK Responsible Person (UK RP) for different products, such as medical devices.
Trainings
For all manufacturers and brand-owners, we offer training services to help you navigate the EU regulatory landscape.
Obelis Group and SYNC Projects are working towards the same goal, “creating compliance for safer markets”. As of February 20, 2022, SYNC Projects Ltd. has been acquired by Obelis Group, allowing us to expand our operations to the Israeli Market, in addition to the European Union, United Kingdom, Switzerland and US.
This collaboration enables us both to fortify the market's safety while delivering top-quality services and expertise. Manufacturers of Medical Devices, In-Vitro Diagnostic Devices and Cosmetics in Israel can now benefit from the security of selling fully compliant and safe products, supervised by the joint expertise of Obelis Group and SYNC Projects’ professional regulatory consultants.
Obelis Group & SYNC PROJECTS
