A revised Therapeutic Products Act (revHMG) will come into force in Switzerland on 26 May 2021.
The rev TPA will amend the legal basis for issuing export certificates and confirmationsFree Sales Certificatein line with the provisions of the European UnionMDR/IVDR.
What will change?
Under current law (Art. 50 para. 2 TPA), all exporters can apply for export certificates and confirmations from Swissmedic, the Swiss Agency for Therapeutic Products. Natural or legal persons domiciled in Switzerland are currently still authorised to do so.
In practice, this means that all economic operators, regardless of their role in the value chain of medical devices, can order export certificates and confirmations from Swissmedic.
In future, it will only be possible for economic operators based in Switzerland to apply for these if they fulfil the role of either manufacturer or authorised representative.
However, importers, distributors and other economic operators are no longer authorised to place orders. Accordingly, Swissmedic will no longer issue a Manufacturing Certificate (MC) once the revised Therapeutic Products Act comes into force.
- The changes will apply immediately after the new TPA provisions come into force.
- The law does not provide for any transitional periods.
Otherwise, as far as we are aware, the EU and Switzerland have not yet come any closer to concluding a Mutual Recognition Agreements (MRA) under MDR regulations, which would ensure the problem-free movement of medical devices as in the MDD era. Consequently, manufacturers are well advised to look for an EU representative (Authorised Representative) for the time being.
On the website of the BAG (Federal Office of Public Health) you will find detailed information on the ongoing revision of medical device legislation.
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