Medical Devices & Special foods and Food Supplements

 

Market Access
Other Services
Scientific Service
Medical Devices\Foods
Proxy Service

Medical Devices

  • Verification of the conformity of the technical documentation and requirements;
  • Notification of medical devices in the database of Ministry of Health;
  • Notification of in vitro diagnostic devices to the Ministry of Health;
  • Preparation of technical dossier;
  • Consultancy for obtaining the CE marking;
  • Obtaining Certificates of Free Sale;
  • Revision of advertising material and, if necessary, request for authorization.

Special foods and food supplements

  • Complying with labeling requirements; notification, evaluation of claims and advertising;
  • Check labeling and defining the information to be included on the label;
  • Notification to the Ministry of Health.

Regulatory support in Extra-EU Countries

  • Support for the registration and maintenance of medicinal products in Extra-EU Countries (e.g. Middle East, North-Central and South America, Asia, Africa, etc.), in accordance to local procedures and requirements.
  • Development of the registration dossier and support during all registration process phases, also with co-operation with local agents.