FDA Authorized Representative Servicing EU and Switzerland

The Law Requires you to Register Through an FDA - AuthRep

Swissmedic prescribes , “If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed. This also applies to manufacturers with their registered place of business in the EU”. The mandate for an Authorized Representative prescribes that the appointed Authorized Representative serve in the supply chain processes for foreign medical products entering the market.

We can Support You in Switzerlan and EU

Our Services include:

  • EU declaration of conformity Verification: we ensure technical documentation has been drawn up and, where applicable, an appropriate conformity assessment procedure has been carried out by the manufacturer;

  • Keep available a copy of the technical documentation: we store and safe keep the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

  • Compliance with the registration obligations: we ensure that the manufacturer has complied with the obligations laid down in Articles 27, 29 and 31;

  • Response to a competent authority requests: we provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device in an official Union language determined by the Member State concerned;

  • Authority and user complaint notification: we cooperate with the competent authorities on any preventive or corrective action and immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents;

  • Termination: we terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.