One company, two roles: why the representative and importer each need their own CHRN

This article is the 32nd 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

A Swiss company that acts simultaneously as the authorized representative of a foreign manufacturer and as the actual importer must hold two CHRNs: the Actors module of swissdamed issues numbers per role, and the system does not support a single number carrying multiple roles. This is not formalism for its own sake. The representative and the importer face different obligation provisions under the MedDO (Art. 51/52 versus Art. 53); if only one number is held, the obligations of the other role have no corresponding registration record, and Swissmedic cannot trace responsibility back to that role during verification. The practical consequence is that a dual-role company must run two complete registration records in parallel, each anchored to its own statutory duties, and any audit, inspection or change of address touches both records separately.

The dual-role constellation is common among smaller market entrants, because a single Swiss entity is cheaper to run than two. The rule of this article is therefore a planning rule rather than a prohibition: the combination itself is lawful, and what the law requires is that each role carry its own verifiable registration record, its own deadlines and its own traceable line of responsibility toward Swissmedic.

2. Legal basis

3. Expert insights

1. One legal entity with two roles is permitted in Switzerland, but the regulator deliberately does not merge them. Under the EU MDR the same entity may combine the roles of authorized representative and importer; Switzerland does not prohibit such a combination, yet it preserves role granularity at the registration level. The basis is that Art. 55(1) lists the manufacturer or its authorized representative and the importer separately as registration subjects, and Art. 55(4) provides that Swissmedic assigns the CHRN after verification — the number is the result of a verification, not the identity of the legal person. The trade-off is explicit: a measure of registration convenience is sacrificed so that the regulator can locate the responsible entity by role.

1. Two numbers bring two sets of deadlines, not one. The registration deadline of the representative anchors on first placement, and the same is true for the importer; the 1-week change-reporting duty of Art. 55(2) runs independently for each number. The common error is updating only the representative-side number while address or contact-person changes on the importer side remain unreported for a long time — at inspection this is treated as two independent violations, not one. Companies that discover this late typically also discover that their internal change-control process was designed around a single master-data record, which is itself part of the root cause.

1. The cost impact is limited, but roles must never be merged to save one fee. Under Annex 2, CHRN issuance carries a fixed fee; two roles mean two issuances. Set against possible subsequent hourly billing (Art. 4(2), CHF 270 per working hour from 1 July 2026), what is saved is only a small fixed fee, while the risk taken on is an unclear attribution of duties. The opposing view is that small businesses would genuinely prefer a single number to simplify maintenance; the system does not support it, so that demand can only be met through internal processes — one responsible person maintaining both numbers — and never by applying for one fewer number.

4. Practical recommendations

1. In the swissdamed Actors module, submit separate applications for the representative role and the importer role for the same legal entity; do not attempt to reuse an already issued number.
2. Maintain independent information files for the two numbers: separate contact persons, places of business, change records and reporting dates, so that no change is ever shared across a single record.
3. Build the budget on the basis of two fixed fees of CHF 200 (CHF 400 in total, practical estimate: subject to the actual Swissmedic invoice).
4. Clarify internally who performs each role: the PRRC of the representative (Art. 52(1)) and the verification owner of the importer may be different natural persons, and the division of duties should be documented in writing.
5. The number format example is CHRN-MF-23456789; where two numbers coexist, cite them separately in labels, accompanying documents and the technical documentation index, avoiding any mixed use.

5. Verification checklist

• □ It has been confirmed that the same legal entity performs both the representative and the importer roles
• □ Separate applications for the two roles have been submitted in the swissdamed Actors module
• □ Both CHRNs have been issued and are in valid status, example format CHRN-MF-23456789
• □ Changes to each of the two numbers are reported within the 1-week deadline
• □ The persons performing the representative-side and importer-side duties have been designated in writing internally
• □ The budget has been built on two fixed fees of CHF 200

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For dual-role constellations GRZAN provides Swiss authorized representative (CH-REP) services together with importer-role compliance support, sets up and maintains the two CHRNs required in the swissdamed Actors module, keeps the 1-week change-reporting duties current for both numbers, and prepares fee budget models covering CHRN fixed fees, device registration fees and hourly-based charges so that Swiss market entry costs stay predictable. For CH-REP appointment, dual-role registration or fee budgeting support for the Swiss market, contact info@grzanglobal.com.