Greetings from
Freyr Switzerland
With a combination of public and private healthcare systems, Switzerland stands as a lucrative destination for foreign medical devices and medicine manufacturers. To ensure the high quality of the products to be imported, SWISSMEDIC – the Swiss agency for therapeutic products (medicinal products and medical devices) oversees the regulations and legal mandates in the region. Organizations have to comply with the Swiss requirements regarding product safety. But the Regulatory procedural complexities involved might challenge the manufacturers’ market entry strategies.
Freyr, a full-service global Regulatory partner focusing exclusively on the entire Regulatory value-chain, assists manufacturers to be abreast with Swiss market updates and guides them through the end-to-end market authorization procedures. Freyr’s Regulatory services in Switzerland span across:
Industries We Serve in Switzerland
Switzerland is a prominent leader in medical technology innovations. After, exiting from the EU’s single market, it developed its regulatory framework – Medical Device Ordinance (MedDo) and In Vitro Diagnostic Devices Ordinance (IVDO). This ordinance was outlined in line with the European Directives, but later it was revised and aligned with the European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746. The MedDO came into effect on May 26, 2021, while the IVDO came into effect on May 26, 2022. Foreign medical device manufacturers must appoint a Swiss authorised representative (CH-REP) to help them comply with Switzerland medical device registration guidelines.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- Dossier Management
- Market Authorization Transfer
- CE Marking
- EMEA filing
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with SWISSMEDIC
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines
