Swissmedic: Market Surveillance of Medical Devices
Swissmedic: Market Surveillance of Medical Devices
Swissmedic, the Swiss regulatory and supervisory authority for therapeutic products, conducts comprehensive examinations for market surveillance and compliance with regulatory requirements for medical devices. These inspections ensure that medical devices comply with legal requirements and do not pose a risk to patients or users.
Types of Inspections by Swissmedic
Approval Review (Conformity Assessment)
- Before being placed on the market, a medical device must undergo a conformity assessment to ensure compliance with the Medical Devices Ordinance (MedDO, SR 812.213) and the Therapeutic Products Act (HMG).
- The manufacturer or the CH-REP is responsible for providing all required documentation, including technical documentation and the declaration of conformity.
- Swissmedic may verify the conformity assessment by the manufacturer or a notified body and, on a case-by-case basis, request additional evidence regarding the safety and performance of the product.
Market Surveillance (Post-Market Surveillance, PMS)
- Swissmedic conducts regular inspections and audits of manufacturers, importers, and distributors to ensure compliance with regulatory requirements and safety standards.
- As part of market surveillance, Swissmedic reviews vigilance reports related to adverse events, incidents, or safety issues associated with medical devices.
- Swissmedic may also carry out spot checks on products in the market and may take corrective actions if necessary.
Product Inspections and Audits
- Swissmedic may conduct both announced and unannounced inspections of manufacturers, importers, and other economic operators.
- These inspections verify whether processes, documentation, and reporting procedures comply with legal requirements.
- If non-compliance is suspected, further investigations or additional product testing may be ordered.
Inspections Related to Recalls and Safety Measures
- If safety risks are identified, Swissmedic may initiate an investigation to determine whether recalls or corrective actions are necessary.
- The CH-REP is responsible for coordinating these actions with Swissmedic and the affected companies.
- Swissmedic monitors the implementation of these measures and ensures that all relevant parties are informed.
Review of Advertising Activities
- Swissmedic ensures that advertising materials for medical devices comply with regulatory requirements.
- Advertising must not contain misleading or unproven statements regarding the safety or effectiveness of a product.
- Violations of advertising regulations may lead to sanctions or injunctions.
Consequences of Non-Compliance
If Swissmedic identifies violations of regulatory requirements during an inspection, various actions may follow:
- Ban on marketing the product in Switzerland
- Product recall from the market
- Administrative measures such as fines or legal action
- Withdrawal of product approval
- Requirement for corrective actions to be implemented
Sources
Swissmedic plays a central role in the surveillance of medical devices in Switzerland. Through these inspections, the agency significantly contributes to the safety and quality of the medical devices available on the Swiss market.
❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!
