Responsibility matrix for the three economic operators: CH-REP, importer and distributor

This article is the 31st instalment of Volume 4, License-holder Import and Fees, of the Swiss Medical Device Registration 50-Article Series. Together with the remaining nine articles of this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below, so that readers can cite this article unambiguously and locate its companion pieces.

1. Key takeaways

Switzerland imposes no licence and no market-entry permit on the CH-REP, the importer or the distributor, yet the obligations of the license-holder side are not lightened in any way as a result. A manufacturer established outside Switzerland must appoint an authorized representative established in Switzerland by written mandate before placing devices on the market (Art. 51(1)); the representative and the importer must each obtain a CHRN; the distributor, although under no mandatory registration duty, must still carry out the pre-placement verification under Art. 54. What truly distinguishes the three roles is therefore not whether a certificate exists, but where the obligations land: the representative carries the formal and safety-related duties and acts as the backstop for vigilance reporting; the importer carries compliance verification and information labelling at the import stage; the distributor carries sampling-based due diligence in the distribution stage. Reading the three roles side by side, one matrix governs them all, and every allocation of duty in this volume of the series hangs on that matrix.

2. Legal basis

3. Expert insights

1. Needing no licence does not mean needing no identity. Art. 55(1) places the registration duty expressly on two categories of entity, the manufacturer or its authorized representative and the importer, with a deadline of 3 months from first placing on the market, while Art. 55(2) requires changes to be reported within 1 week. The legislative trade-off is clear: the regulator sets no prior-approval gate and instead obtains a traceable identity number after the event, leaving the speed of market access to companies while keeping traceable responsibility in the hands of Swissmedic. The opposing error is equally real: companies assume that where no licence exists there is no filing milestone, remember registration only in the fourth month after first placement, and thereby fall into delay, because a late filing is a violation even though no licence was ever required.

1. The representative’s duties are a Swiss-reinforced edition, not a copy of the EU MDR. Art. 52(1) requires the CH-REP to maintain permanently and continuously at least one PRRC, for which the EU MDR has no counterpart; Art. 51(3bis) allows an arrangement under which the manufacturer submits the technical documentation directly to Swissmedic upon request, but the CH-REP must ensure submission within 7 days; Art. 66(2bis) further makes the CH-REP the backstop for reporting serious incidents and FSCA occurring in Switzerland and for proactively submitting trend reports covering events both inside and outside the country. The common logic across these three points is that the Swiss regulator can only reach an entity established in Switzerland, so being reachable and being accountable are built into the representative as a hard configuration. The price is that the standing cost of a Swiss representative is markedly higher than that of an EU counterpart.

1. The verification lists of the importer and the distributor are highly similar, but the exemption structures differ. Art. 53(1) and Art. 54(1) each contain five checks; the difference is that Art. 54(2) allows the distributor to verify, on a sampling basis, every item other than whether the importer has provided information under Art. 53(2), while the importer enjoys no such exemption. The legislative judgment is that the importer is the last complete gate through which foreign products enter Switzerland and must therefore verify every single item, whereas the distributor sits downstream in distribution and may trade sampling for efficiency. Read the other way round, this is precisely why handing the importer role to a company that only performs logistics is a high-risk arrangement: that company bears a full verification duty, not a mere receiving signature.

4. Practical recommendations

1. Fix the legal entities, addresses and contact persons of the three roles in a single role matrix before discussing any mandate; once roles are misplaced — for example, a distributor signed up as an importer — the full verification duty of Art. 53 lands on an entity that lacks verification capability.
2. When the foreign manufacturer signs the written mandate under Art. 51(1), settle at the same time the direct-submission arrangement of Art. 51(3bis) and write the 7-day response deadline into the service terms of the mandate letter.
3. Build milestones from the day of first placement as T0: complete CHRN registration within 3 months of T0, and report any change to the registration information within 1 week thereafter; a missed deadline is treated as a continuing violation.
4. Configure the PRRC of the CH-REP as a permanent position in line with Art. 52(1), avoiding any substitution of external consultants providing on-demand support for the statutory wording of permanent and continuous availability.
5. The distributor should retain the written sampling plan and sampling records; the sampling ratio and the selection of batches must be defensible, otherwise the exemption of Art. 54(2) will be difficult to invoke during an inspection.

5. Verification checklist

• □ The foreign manufacturer has signed the written mandate under Art. 51(1) and the representative is established in Switzerland
• □ The CH-REP maintains at least one PRRC permanently and continuously under Art. 52(1)
• □ Both the representative and the importer have obtained a CHRN and the registered information matches the actual situation (Art. 55(1))
• □ Registration completed within 3 months of first placement and changes reported within 1 week (Art. 55(2))
• □ The importer has labelled its name, place of business and contact address on the device, the packaging or the accompanying documents (Art. 53(2))
• □ The distributor has established and keeps a written sampling plan and records for the sampling verification under Art. 54(2)

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For this topic GRZAN acts as or supports your Swiss authorized representative (CH-REP), maintains the standing PRRC configuration required by Art. 52(1), manages CHRN registration and change reporting in swissdamed, and reviews the division of duties among the CH-REP, importer and distributor so that the role matrix matches the statutory obligations before the first device is placed on the market. GRZAN also builds fee budget models covering CHRN fixed fees, device registration fees and hourly-based charges, keeping Swiss market entry costs predictable. For CH-REP appointment, role-matrix review or fee budgeting support for the Swiss market, contact info@grzanglobal.com.