Swissmedic, the Swiss Agency for Therapeutic Products, has conducted a focus campaign on importers of medical devices, resulting in significant findings that impact the industry. As of January 30, 2026, importers must adhere to stricter guidelines to ensure compliance with medical device regulations.
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Findings of the Focus Campaign | Frequently Asked Questions | Conclusion | Disclaimer
Findings of the Focus Campaign
The focus campaign revealed that several importers were not complying with the requirements for medical devices, particularly in regards to labeling and instructions for use. Swissmedic emphasizes the importance of accurate labeling and clear instructions to ensure patient safety.
Labeling Requirements
Importers must ensure that medical devices are labeled in accordance with the relevant regulations, including the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Labels must be clear, concise, and in the official language of the country where the device is marketed.
Instructions for Use
Instructions for use must be provided with each medical device, and these instructions must be clear, concise, and easy to understand. Importers are responsible for ensuring that instructions are accurate and comply with the relevant regulations.
Frequently Asked Questions
1. What are the consequences of non-compliance?
Importers who fail to comply with the requirements for medical devices may face penalties, including fines and suspension of their licenses.
2. How can importers ensure compliance?
Importers can ensure compliance by conducting regular audits, providing training to staff, and implementing quality management systems.
Conclusion
The focus campaign conducted by Swissmedic highlights the importance of compliance with medical device regulations. Importers must take immediate action to ensure that their products meet the required standards, and they must be prepared to face the consequences of non-compliance.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Importers should consult the relevant regulations and seek professional advice to ensure compliance.
For full information about the Swissmedic announcement, see the link below.