Market surveillance and on-site inspections: TPA Art. 58 and the Swissmedic inspection logic

This article is the 44th instalment of Volume 5, Post-market Compliance and Regulatory Developments, of the 50-part series on medical device registration in Switzerland. Together with the remaining nine articles of this volume it forms the complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below.

1. Key takeaways

Market surveillance in Switzerland runs on two parallel tracks. The first is authorised by TPA Art. 58, under which Swissmedic exercises official market surveillance over economic operators, including entering premises, inspecting documents and taking samples. The second track operates on the healthcare institution side, where the GPMV-Spital guidance and the checklist IN615_10_004d_CL govern the device stewardship systems of hospitals. Treating inspection preparation as an exercise of assembling documents after a notification arrives is a high-risk approach in Switzerland. The surveillance power originates in the statute rather than in any licence condition, and the typical trigger for an inspection is a vigilance report, a complaint or a sampling result. Companies that can evidence their obligations continuously are inspected differently from companies that must reconstruct their records under time pressure.

2. Legal basis

3. Expert insights

1. The surveillance power sits at the level of the statute and is unaffected by whether a CHRN has been obtained. Official market surveillance under TPA Art. 58 is the general public authority Switzerland exercises over therapeutic products once they are placed on the market, and its exercise is not conditional on any registration step being complete. This means Swissmedic can open an inspection even while a registration procedure is still pending. The trade-off has two faces. On one side, the design guarantees there is no coverage gap in oversight. On the other, a company cannot use the status of its paperwork as a buffer, and the only defence that works is continuous, ordinary-course record keeping that is already in place when the inspector arrives.

2. The first point of inspection is usually the verification records of the economic operators. MedDO Art. 53(1) requires the importer to verify, before each placing on the market, the CE marking, the declaration of conformity, the designation of a CH-REP, the label and instructions for use, and the UDI. Art. 54(1)(2) requires the distributor to verify the same categories of items and permits sampling-based verification for all items except the representative information. What inspectors actually probe is not whether the checks were done but how it can be proven that they were done. The counterpoint lies in the sampling permission itself: Art. 54(2) lowers the cost of verification, but it also turns the reasonableness of the sampling plan into a new point of contention. A sampling rate that is too low will be treated as a failure to exercise the duty at all.

3. The hospital side is the underestimated segment of the Swiss surveillance system. Swissmedic has issued dedicated material for healthcare institutions: the GPMV-Spital good practice guidance on hospital device stewardship dated 1 April 2026, the checklist IN615_10_004d_CL dated 10 September 2026, and the guidance Procurement of medical devices in healthcare institutions, MU600_00_006e_MB, V5.3, dated 20 March 2026. The judgement behind this investment is that hospitals are both users of devices and reporting subjects as users under TPA Art. 59 para. 3, so extending inspection to procurement and stewardship adds a front-line filter upstream of vigilance. For manufacturers, the compliance pressure on hospitals travels back down the supply chain and reappears as demands on documentation quality and response speed.

4. Practical recommendations

1. Build a per-unit or per-batch verification record template around the five verification items of Art. 53(1), retaining the verifier, the time and the traceability of the batch checked.
2. Where a distributor uses sampling verification under Art. 54(2), document the sampling rate, the sample selection rules and the decision criteria, and review their reasonableness at fixed intervals.
3. Agree with the CH-REP on an inspection-response owner and response deadlines so technical documentation can be sent directly to Swissmedic within 7 days under the Art. 51(3bis) mechanism.
4. Treat vigilance reports, customer complaints and sampling results as internal early-warning signals: any single trigger opens a self-review, without waiting for a regulator’s notice.
5. Once a year, review your own obligations list against the current Swissmedic guidance Obligations Economic Operators CH (MU600_00_016e_MB, 2026 edition dated 1 May 2026).

5. Verification checklist

• □ The importer maintains pre-placement verification records covering the five items of Art. 53(1).
• □ The distributor’s sampling verification plan is documented and reviewed periodically under Art. 54(2).
• □ A 7-day direct-submission mechanism for technical documentation is agreed with the CH-REP under Art. 51(3bis).
• □ PRRC contact details are accurate and integrated into the inspection-response process under Art. 49.
• □ The document package for hospital customers is complete and includes trilingual product information.
• □ The annual self-review has been completed against the current Swissmedic guidance Obligations Economic Operators CH.

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers entering or operating in the Swiss market with post-market compliance services, covering vigilance reporting, field safety corrective actions and Swissmedic inspection readiness. Our team builds verification-record systems under MedDO Art. 53 and Art. 54, coordinates inspection response through the CH-REP and keeps evidence packages inspection-ready at all times. For support with your Swiss post-market obligations, contact info@grzanglobal.com.