SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
recognises conformity certificates (CE markings) issued by recognised bodies in EU/European Economic Area (EEA) countries (Article 25 para- graph 4 of the MedDO and Article 21 paragraph 4 of the IvDO), provided additional requirements are met. These additional requirements include the appointment of an authorised representative in Switzerland, who is responsible for ensuring compliance with both formal and safety-related requirements and who must be registered with Swissmedic (Articles 51 and 55 of the MedDO and Articles 44 and 48 of the IvDO). In terms of recent developments, in 2022, the two Swiss parliamentary chambers adopted a motion mandating the Swiss Federal Council to amend the current legislation so that medical devices conforming to non-European regulatory systems (including FDA-approved devices) can be placed on the market in Switzerland by way of unilateral recognition. The FOPH is currently examining how this motion can be implemented. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices The manufacture of medicinal products in Swit- zerland is subject to a mandatory licence (Article 5 paragraph 1 lit a of the TPA). The same applies to anyone withdrawing blood from humans for the purpose of transfusion or the manufacture of therapeutic products or for supply to a third party (Article 34 of thr TPA). The licence is issued if Swissmedic has successfully verified during an inspection that the necessary technical and operational conditions have been fulfilled and an appropriate system of quality assurance exists
(Article 6 of the TPA and Articles 3 et seq of the MPLO). The licence is issued for an unlimited period of time, whereby Swissmedic performs periodic inspections and may revoke licences if the requirements are no longer fulfilled. Manufacturers of medical devices are not subject to licensing requirements in Switzerland. How- ever, if a manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised rep- resentative in Switzerland who is responsible for the related formal and safety-related aspects and is registered with Swissmedic (Articles 51 and 55 of the MedDO, Articles 44 and 48 of the IvDO, Article 11of the EU-MDR/EU-IVDR). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Any person engaged in the wholesale trade of medicinal products must possess a licence (Arti- cle 28 paragraph 1 of the TPA). The licence is issued following an inspection by Swissmedic (Article 28 paragraph 2 of the TPA and Articles 11 et seq of the MPLO). No licences are required for the wholesale (Article 4 paragraph 1 lit i of the MedDO and Article 4 paragraph 1 lit h of the IvDO) of medi- cal devices. Foreign manufacturers, however, need to appoint an authorised representative domiciled in Switzerland (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices ).
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