A revised Therapeutic Products Act (Heilmittelgesetz, revHMG) will come into force in Switzerland on May 26th, 2021. Is there a need for an Authorised Representative?
In the revHMG, the legal basis for issuing export certificates and confirmations (Free Sales Certificate) will be adapted, analogous to the provisions of the European Union (MDR / IVDR).
What will change?
In accordance with currently applicable law (Art. 50, Paragraph 2, HMG), all persons carrying out the work can apply for export certificates and confirmations from Swissmedic, the Swiss therapeutic products institute. Natural or legal persons based in Switzerland are currently entitled to do so. In practice, this basically means all economic actors, regardless of their role in the value chain of medical devices, can order export certificates and confirmations from Swissmedic.
In the future, it will only be possible for economic operators based in Switzerland to apply for this if they either assume the role of manufacturer or Authorised Representative.
Importers, distributers and other economic actors are no longer entitled to place orders. Accordingly, Swissmedic will no longer issue a Manufacturing Certificate (MC) after the revised Therapeutic Products Act has come into force.
- The changes apply immediately after the new HMG provisions come into force.
- The law does not provide for any transition periods.
Otherwise, the EU and Switzerland have not yet come any closer to the conclusion of a Mutual Recognition Agreement (MRA) under MDR regulations, which would guarantee the trouble-free movement of medical devices as in the MDD era. Accordingly, manufacturers are well advised to take care of an Authorised Representative for the time being.
On the BAG website (Bundesamt für Gesundheit, Federal Office of Public Health) you will find detailed information on the ongoing revision of medical device law.