Regulatory GuideOctober 12, 2026 · 20 min read · VEMERIX

A CHRN Is Not a Device Registration: Swiss Importer Linking in swissdamed

Swiss importers link their CHRN to devices someone else has registered; they never register products. What must exist before linking, who pays which fee, and how 31 December 2026 and 1 April 2027 split between supplier and importer.

Diagram of the swissdamed chain: a Swiss authorised representative registers a foreign manufacturer's device UDI-DIs, the Swiss importer links its CHRN to those records, and distributors have no registration duty.

The scenario: what must be true before you place a device on the Swiss market?

This guide is for a Swiss importer or distributor that buys sterile single-use devices from a manufacturer outside Switzerland, and for that manufacturer's export team. A typical case: you buy CE-marked consumables such as circumcision devices, trocars or drainage accessories from a factory in China that has appointed a Swiss authorised representative (CH-REP). Your company already holds an importer CHRN in the format CHRN-IM-2xxxxxxx.4 Year-end orders are being placed and the linking function is newly live. Do you have to register the devices yourself, what has to be true before the first unit is placed on the Swiss market, and which deadline belongs to whom?

The short answer: Swiss importers never register devices in swissdamed.1 Device registration sits with Swiss manufacturers and Swiss persons who assemble systems or procedure packs and, for a foreign manufacturer, with its CH-REP, which can let the foreign manufacturer upload devices to its own mandate.4 The importer's duty under Art. 53(4) MedDO and Art. 46(4) IvDO is to add its own details to each registered device it places on the market. swissdamed implements that duty as a link between the importer actor and each device's UDI-DI, the device-identifier part of the unique device identifier.1

The catch is dependency. You cannot link what your supplier has not registered, and swissdamed only lets you link UDI-DIs that are registered with the status “On the market”.1 The supplier's transition ends on 31 December 2026; from 1 January 2027, registration must precede placing a sales unit on the market.4,5 Swissmedic's information sheet on economic operators also lists, from 1 January 2027, an importer duty to verify that devices are registered in swissdamed.9 Swissmedic's tolerance until 1 April 2027 covers only a missing link. It does not cover an unregistered device.1 The same confusion between an operator registration and product authorization appears elsewhere; compare what a Thai importer establishment registration does and does not cover.

swissdamed has two modules: the Actors module, used for economic-operator registration since August 2024, and the UDI Devices module, open for voluntary device registration since August 2025 and mandatory since 1 July 2026.2 An importer link is the last step in a chain whose earlier steps belong to other parties. Five conditions have to hold:

  1. A designated CH-REP. A device whose manufacturer is not domiciled in Switzerland may only be placed on the market if the manufacturer has designated an authorised representative domiciled in Switzerland by written mandate (Art. 51(1) MedDO).7 The CH-REP registers as an actor and receives its own CHRN; Swissmedic's format is “CHRN”, a role abbreviation and an eight-digit number.15
  2. A mandate entered in swissdamed and currently valid. Mandates reported to Swissmedic before swissdamed were not imported and must be entered again.4 swissdamed identifies a foreign manufacturer by a mandate ID rather than a CHRN.5 If today's date falls outside the mandate's “Mandate valid from” and “Mandate valid until” dates, the mandate shows “Not valid”, and devices under it cannot be set to “On the market”.12
  3. Device records uploaded under that mandate. The CH-REP, or a foreign-manufacturer user it has given the “UDI Editor” role on the mandate, uploads each Basic UDI-DI and UDI-DI by XML, online editor or machine-to-machine interface. Where a device has electronic instructions for use, the eIFU URL is mandatory.4,11 Nothing is copied over from EUDAMED automatically.4
  4. Market status set to “On the market”. Uploaded records stay in “Draft”, hidden from the public and not considered registered, until a market status is set; drafts are deleted automatically 30 days after their last update. A UDI-DI marked “No longer placed on the market” cannot be linked.11
  5. Your own importer actor and a linking user. The importer needs a CHRN in the importer role under Art. 55 MedDO or Art. 48 IvDO. Swissmedic has up to 30 days to process an application, and an objection restarts that period once the gaps are fixed.4 The person who registers the importer actor receives the “UDI Linker” profile, which can link and unlink UDI-DIs but cannot upload or update devices.12

If an earlier step is missing, the importer cannot fix it alone. Examples include a mandate never entered in swissdamed, a “Not valid” mandate, or a UDI-DI on the carton that differs from the registered one. swissdamed's bulk-link check reports a code as not linkable if it is not found, was not registered by a foreign manufacturer, is marked “No longer placed on the market”, exists under two issuing entities, or was entered twice.11

RoleActor registration (CHRN)MandateDevice (UDI-DI) registrationImporter linkDevice registration fee
Swiss manufacturerRequired (for example CHRN-MF-…)15Not applicableRegisters its own devicesNot applicableInvoiced directly10
Foreign manufacturerNo Swiss CHRN; must designate a CH-REP by written mandate4,7Held by the CH-REP; identified by a mandate ID5Through its mandate, by the CH-REP or by a foreign-manufacturer user with the UDI Editor role4Not applicableCalculated per manufacturer; invoice goes to the CH-REP10
Swiss authorised representative (CH-REP)Required (CHRN-AR)Creates the mandate and maintains its validity dates12Registers mandated devices or delegates the uploadNot applicableReceives a separate invoice per mandate10
Swiss importerRequired (CHRN-IM)4NoneCannot register devices; its users hold the UDI Linker profile12Links its CHRN to each imported UDI-DI1None; linking is free1
Swiss distributorNo registration (“no / not possible”)9NoneNoneNoneNone
Table 1: Who does what in swissdamed

Source: Swissmedic swissdamed FAQ, user guides of 1 October 2026, fee information sheet of 9 July 2026 and economic-operator information sheet of 1 May 2026; MedDO Art. 51 and 55 (checked 12 October 2026). Swiss persons who assemble systems or procedure packs register as actors and register their systems and procedure packs much as manufacturers do.

Two role boundaries catch buyers out. First, an importer is not appointed: Swissmedic says the role arises from the activity of a Swiss person placing a device from another country on the Swiss market. A “distributor” that buys straight from a foreign factory is therefore the importer for those goods.9 Second, one company may hold several roles, but each needs its own application; Swissmedic does not issue a single CHRN for several roles.4

What does an importer do in swissdamed, and what should it never do?

Swissmedic designed swissdamed to resemble EUDAMED, but the importer data differ. Its May 2026 webinar lists “Link between Swiss importer and the imported UDI-DIs” as a swissdamed-only element, and the link between an EU importer and the foreign manufacturer as EUDAMED-only.5 The legal source is shared, because Swiss law applies Article 13(4) of the EU regulations to importers.1 What differs is the level of detail. A team that handles both markets should not assume its EUDAMED set-up covers Switzerland; there is no interface between the two databases.4

What a Swiss importer does:

  • Verify, then place. Before placing a device on the market, check the conformity marking, the declaration of conformity, that the manufacturer is identified and has designated a CH-REP, the labelling and instructions for use, and UDI assignment (Art. 53(1) MedDO).7 From 1 January 2027, Swissmedic's information sheet adds verifying that the device is registered in swissdamed.9
  • Link each imported UDI-DI. Under “My UDIs” → “UDI Linking”, search one or several UDI-DIs (separated by spaces), select them and confirm; a “Linked” column shows which are already linked to your importer. For volume, “Bulk link” accepts a space-separated list of UDI-DIs or EUDAMED IDs, up to 1,000 per operation.11,1
  • Unlink when the record is wrong. A link can be cancelled with the unlink function.1 Swissmedic sets no rule on when to unlink. A sensible internal rule is to review links when you stop importing a UDI-DI or find one linked in error.
  • Keep actor data current. Report changes to your actor data to Swissmedic within one week (Art. 55(2) MedDO; Art. 48(2) IvDO). swissdamed also flags actors that have not been updated for 365 or 720 days until their data are confirmed.4
  • Make sure your details travel with the goods. Indicate your name, place of business and contact address on the device, on its packaging or in a document accompanying the device (Art. 53(2) MedDO; Art. 46(2) IvDO).7,8 Swissmedic accepts, for example, a delivery note, invoice, customs document or sticker on the packaging as such a document.9

What a Swiss importer should not do:

  • Do not try to register the device. The UDI Linker profile cannot upload or update UDIs; a missing record goes back to the manufacturer's CH-REP.12,1
  • Do not rely on an EU SRN. An SRN issued through EUDAMED by an EU Member State authority does not replace the CHRN.4
  • Do not stretch one CHRN across roles. If you also act as CH-REP or manufacturer for other lines, each role needs its own application and CHRN.4
  • Do not ask downstream distributors for a CHRN. Distributors have no registration requirement in swissdamed.4 They do have to verify that an imported device carries the importer's details (Art. 54(1)(d) MedDO), which is another reason to get those details right.7

Which deadline binds whom: 31 December 2026, January 2027 or 1 April 2027?

The supplier's registration deadline and the importer's linking tolerance are easy to conflate in a commercial negotiation. Table 2 sets out the dates Swissmedic has published and what each means for an importer.

DateWhoWhat happensWhat it means for an importer
6 August 2024Swiss manufacturers, CH-REPs, importersActors module goes live in swissdamed13Your importer CHRN is the prerequisite for any link.
18 August 2025Manufacturers, assemblers, CH-REPsVoluntary device registration opens in the UDI Devices module10,13Some suppliers already have records; check the public search.
1 July 2026Manufacturers, assemblers, CH-REPsRegistration becomes mandatory for devices whose sales units are placed on the Swiss market after 1 July. It replaces notification for class I devices, systems and procedure packs, MD-DEVIT products and IVDs; notification continues for repackaged or relabelled, in-house, custom-made and DEVIT products.3Transition to 31 December 2026, except devices with a serious incident, field safety corrective action or trend to report, which must be registered immediately.3
1 October 2026Importers; CH-REPsImporter linking goes live; mandates outside their validity dates are now automatically shown as “Not valid”.1,13Link as soon as the supplier's UDI-DIs are “On the market”.
10 November 2026All swissdamed usersSwissmedic webinar on registration, importer linking, fees, device transfer and data download14Watch for clarifications before year-end.
31 December 2026Manufacturers, assemblers, CH-REPsEnd of the registration transition; fee reference date for UDI-DIs then “On the market”4,10From 1 January 2027 a device must be registered before a sales unit is placed on the market.5
January 2027Swiss manufacturers and assemblers; CH-REPs for foreign manufacturersFirst invoices for UDI-DIs registered up to 31 December 2026; later registrations billed monthly10No Swissmedic invoice to the importer for linking.1
1 April 2027ImportersEnd of the linking tolerance1Any delay between placing an imported device on the market and linking it is no longer accepted.1
1 November 2028Spectacle frames, spectacle lenses, ready-to-wear reading spectaclesLater date for Master UDI-DI assignment, registration and linkage1Applies only to these eyewear products.
Table 2: swissdamed dates that matter to a Swiss importer

Source: Swissmedic importer page, announcement of 1 July 2026, FAQ, release notes, fee information sheet, webinar presentation of 28 May 2026 and event notice for 10 November 2026 (checked 12 October 2026).

The practical point: do not wait until April 2027 to check your supply chain. Swissmedic's wording is: “During the period until 1 April 2027, Swissmedic will not take any enforcement measures solely due to a missing link.”1 By its terms that covers the link only. Nothing in it excuses a device left unregistered after 31 December 2026 or one under an invalid mandate. If a supplier misses 31 December 2026, the importer's problem in early 2027 is not the missing link. It is whether the device may be placed on the market at all, since registration must now come first and the importer is expected to verify it.5,9

What does linking cost, and who pays the registration and CHRN fees?

Three charges are easy to blur together: the actor fee for a CHRN, the device registration fee and the importer link. They have different payers and different timing. Both fees come from the Swissmedic fee ordinance (FeeO-Swissmedic, SR 812.214.5): Annex 2 sets CHF 200 for issuing a CHRN and, since 1 July 2026, CHF 200 and CHF 20 for device registrations, and Art. 13a caps a manufacturer's registration fees at CHF 10,000 per calendar year.6,10

ChargeAmountWho is invoicedTiming and rules
Issuing a CHRN (any role)CHF 200 flat fee4,6The applicant: Swiss manufacturer, CH-REP, importer or assemblerCharged on issue. A refused application is charged at actual cost on an hourly basis (Art. 4(2) FeeO-Swissmedic).4
Device registration: basic feeCHF 200 for the first UDI-DI a manufacturer or assembler registers in a calendar year10Swiss manufacturers and assemblers directly; for foreign manufacturers, the CH-REP, with a separate invoice per mandate10One-time per UDI-DI. The first billing, from January 2027, covers UDI-DIs registered up to 31 December 2026 that are “On the market” on that date; later registrations are billed monthly.10
Device registration: unit feeCHF 20 for each additional UDI-DI registered in the same calendar year10As aboveUpdating an existing UDI-DI is free; re-registering a discarded UDI-DI is charged again.10
Annual ceilingCHF 10,000 per calendar year per manufacturer or assembler (Art. 13a FeeO-Swissmedic)6,10As aboveReached at 491 UDI-DIs; nothing further from the 492nd in that year. The cap applies per manufacturer, not across all of a CH-REP's mandates, and resets on 1 January.10
Not chargedCHF 0Not applicableDrafts, deleted uploads and UDI-DIs marked “No longer placed on the market” as at 31 December 2026.10,11
Importer linkCHF 0Not applicable“Importers do not incur any costs for this linkage.”1
Table 3: swissdamed charges by payer

Source: Swissmedic medical device registration fee information sheet (9 July 2026), swissdamed FAQ and importer page; FeeO-Swissmedic (checked 12 October 2026).

Two consequences follow. An importer has no Swissmedic charge to recover for linking, so if a supplier or service provider prices the linking step, that is a commercial charge rather than a pass-through. And a foreign manufacturer's device fees land on its CH-REP's desk, first in January 2027.10 Who finally bears them is a question for the mandate and the supply contract, which is why the agreement terms below name the payer.

One-time device registration fees for UDI-DIs one manufacturer registers in a single calendar year
1 UDI-DIRegistration fee (CHF): 20020010 UDI-DIsRegistration fee (CHF): 38038014 UDI-DIs (worked example)Registration fee (CHF): 46046050 UDI-DIsRegistration fee (CHF): 1,1801,180250 UDI-DIsRegistration fee (CHF): 5,1805,180491 or more UDI-DIs (cap)Registration fee (CHF): 10,00010,000
View chart data
CategoryRegistration fee (CHF)
1 UDI-DI200
10 UDI-DIs380
14 UDI-DIs (worked example)460
50 UDI-DIs1180
250 UDI-DIs5180
491 or more UDI-DIs (cap)10000
  • Computed by VEMERIX from Swissmedic's fee information sheet of 9 July 2026: CHF 200 for the first UDI-DI registered in the calendar year plus CHF 20 for each additional one, capped at CHF 10,000 per manufacturer per year. Each UDI-DI is billed once, in the year it is registered; the amounts do not recur for UDI-DIs registered in earlier years. Assumes these are the manufacturer's only registrations that year. Importer linking costs nothing.

A worked example with hypothetical numbers: a manufacturer whose circumcision-ring family has 14 size codes, each with its own UDI-DI, and which registers nothing else that year pays CHF 460 once (CHF 200 + 13 × CHF 20). If it had already registered another device earlier in the year, the basic fee would already be spent and the 14 UDI-DIs would add CHF 280. The same UDI-DIs are not billed again in later years.10

How do you check a supplier's Swiss registration before ordering?

swissdamed's public search shows registered device data and the registered economic operators, so an importer does not have to rely on a supplier's assurance that registration is in hand.2,4 Draft records are not public, so a device that does not appear has not been registered.11 The checklist below uses four checks in the public search and the published actor list, one in your own login and one on the goods.

StepCheckWherePassIf it fails
1Device record existsPublic UDI/device searchThe exact UDI-DI on your labels, and its Basic UDI-DI, are returnedNot registered. Ask the CH-REP for a date; from 1 January 2027 do not place the device on the market until it is registered.5
2Market statusDevice details in the public search“On the market”A UDI-DI marked “No longer placed on the market” cannot be linked; ask the manufacturer why.11
3Mandate validityPublic UDI/device search resultsNo “Not valid” mandate indicationWithout a valid mandate no devices may be placed on the Swiss market (Art. 51 MedDO); escalate before shipping.4
4CH-REP identityPublic actor search or Swissmedic's published actor listThe CH-REP named on the label appears as a registered authorised representativeClarify before placing on the market; Art. 53(1)(c) MedDO requires the importer to verify that the manufacturer has designated an authorised representative.7,15
5Your link“My UDIs” → “UDI Linking”, logged in as UDI LinkerThe UDI-DI shows as linked to your importer actorCheck the stated reason: not found, not registered by a foreign manufacturer, no longer on the market, two issuing entities or a duplicate entry.11
6Importer details with the goodsDevice, packaging or accompanying documentYour name, place of business and contact address appearAdd them before placing on the market, on the packaging or in an accompanying document such as a delivery note, invoice or sticker.7,9
Table 4: Pre-shipment swissdamed checklist for a Swiss importer

Source: VEMERIX editorial checklist built from the Swissmedic FAQ, user guides and economic-operator information sheet and from MedDO Art. 51 and 53 (checked 12 October 2026). A working aid, not a Swissmedic form.

Running these checks on every non-Swiss supplier before year-end shipments leaves time for its CH-REP to complete registrations before the transition ends on 31 December 2026.3 For the label side of the CH-REP role, see our guide to EU REP, UK Responsible Person and CH-REP indications on device labels.

What happens when a CH-REP mandate lapses or actor data goes stale?

A completed link does not freeze a device's status. In swissdamed, a foreign manufacturer's devices are registered under its mandate, so what happens to the mandate happens to the devices.11,12

Since 1 October 2026, swissdamed automatically marks a mandate “Not valid” when the current date lies outside its “Mandate valid from” and “Mandate valid until” dates, and emails the CH-REP.13,4 The indication appears in the mandate details, in the details of the associated UDIs and in public device search results.4 While a mandate is “Not valid”, devices can still be uploaded and updated, but none can be set to “On the market”.12 Extending or correcting the dates restores the status “Registered”.4

If the validity is not updated within the specified deadline, Swissmedic may take legal measures in the context of an administrative procedure. This includes, in particular, the inactivation of the mandate, which results in the linked UDI-DIs being assigned the market status “No longer placed on the market”.— Swissmedic, swissdamed Questions and answers, mandate section

Swissmedic's Actors user guide sets that deadline at 30 days after the mandate becomes “Not valid”.12 A second path exists. If the CH-REP itself is inactivated, its mandate admins have 30 days, which can be postponed once by another 30, to transfer or inactivate each mandate. After that the mandate is inactivated automatically and its devices change from “On the market” to “No longer placed on the market”.12 A proper change of CH-REP uses swissdamed's mandate transfer, which moves the mandate and its registered devices to the new representative on the transfer date.12,11

For the importer, a valid CHRN-IM and a completed link do not help if the mandate behind the device lapses. Art. 51(1) MedDO allows a foreign manufacturer's device on the market only through a designated Swiss authorised representative, and Swissmedic's FAQ states that without a valid mandate no devices may be placed on the Swiss market.7,4 Placing on the market refers to each individual device, so stock not yet placed on the market should be held until the mandate is valid again.9

Stale importer data is a separate problem. Changes to your actor data must be reported within one week (Art. 55(2) MedDO), and swissdamed flags actors that have not been updated for 365 or 720 days until the data are confirmed.7,4 If an importer actor is inactivated, its users drop to read-only access and can no longer link.12

What should a distribution agreement fix about swissdamed steps?

Swiss law assigns the database duties but does not settle commercial delays between supplier and importer. The terms below are commercial practice, not legal requirements, and the numbers in them are starting points to negotiate.

  • Registration covenant. The manufacturer, through its CH-REP, registers every contracted UDI-DI in swissdamed with the status “On the market” before the first lot for Switzerland ships, and keeps the UDI-DIs on the labels identical to the registered ones.
  • Mandate maintenance and notice. The manufacturer keeps its CH-REP mandate valid, uses swissdamed's mandate transfer for any change of representative, and gives written notice, for example 90 days, before the mandate expires, ends or moves to another CH-REP.
  • Fee allocation. State who bears the CHRN and device registration fees invoiced to the CH-REP, including the one-time CHF 200 and CHF 20 per UDI-DI charges, and record that importer linking carries no Swissmedic fee.
  • Data hand-over and linking window. The manufacturer sends the UDI-DIs and Basic UDI-DIs for each order early enough, for example 15 business days before dispatch, for the importer to confirm registration and link before the first unit is placed on the market.
  • Remedies. Allocate the costs of quarantined stock, added importer stickers or delayed deliveries caused by a missing registration or an invalid mandate attributable to the manufacturer or its CH-REP.

For the wider document pack these clauses sit beside, see the market-entry evidence pack for disposable circumcision devices. For the EU counterpart of this database discipline, see whether a missing EUDAMED device record is still allowed.

Where VEMERIX fits—and where due diligence still begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

Its catalogue lists the Auto-Circumcision Ring (Circumcision Device) as CE-marked and registered with China's NMPA as a Class II device (Lu Mech Reg. 20172020238), EO-sterilized and supplied in individual sterile blisters across 14 size codes for the treatment of phimosis and redundant prepuce. That listing says nothing about Switzerland. VEMERIX does not claim a Swiss authorised representative, a CHRN, a swissdamed mandate or swissdamed device records, and nothing in this guide should be read as implying one.

A Swiss importer evaluating the ring, or any other non-Swiss consumable, should treat Table 4 as an entry condition rather than a formality. Before the first order, ask who the CH-REP will be, when the mandate and each UDI-DI will be registered, and who bears the registration fees, then write the answers into the distribution terms. The product catalogue is available to download; certificates, instructions for use and technical packs are supplied to qualified buyers on request through the contact form, and the quality page summarises the manufacturing and quality-system background.

Frequently asked questions

Does a Swiss distributor that never imports need a CHRN?

No. Swissmedic issues CHRNs to Swiss manufacturers, authorised representatives, importers and persons who assemble systems and procedure packs (Art. 55 MedDO; Art. 48 IvDO), and distributors have no registration requirement in swissdamed.4 Check the activity, though: a Swiss company that brings a device in from another country is the importer for that device, whatever its contracts call it.9

Does an EUDAMED SRN work in Switzerland?

No. An SRN issued through EUDAMED by an EU Member State authority does not replace the CHRN.4 The databases are not connected either. There is no interface, so Swissmedic cannot transfer or synchronise EUDAMED data, and the manufacturer's side must upload device data to swissdamed itself, for example by re-using an XML file downloaded from EUDAMED.4

No. There is no placeholder link. swissdamed links only UDI-DIs registered with the status “On the market”, and a code it cannot find is reported as not linkable.1,11 The fix sits with the manufacturer and its CH-REP.

Do importers pay the CHF 200 and CHF 20 swissdamed registration fees?

No. Linking costs importers nothing.1 Device registration fees are calculated per manufacturer or assembler and invoiced to the Swiss manufacturer or, for a foreign manufacturer, to its CH-REP, and each UDI-DI is billed once.10 In swissdamed, the importer's own Swissmedic charge is the CHF 200 for issuing its CHRN, plus hourly charges in specific cases such as a refused application.4

Do legacy devices and eyewear follow the same deadlines?

Not entirely. “Old devices”, placed on the Swiss market before the MDD/AIMDD/IVDD rules or under them before the EU MDR/IVDR applied, need no swissdamed registration, although vigilance reporting still applies. “Legacy devices” under Art. 101 MedDO or Art. 82 IvDO must be registered by 31 December 2026 if further sales units are placed on the market after 1 July 2026, unless the same device is already registered under the current rules.4 Legacy devices that would need a Master UDI-DI cannot be uploaded; their vigilance cases go to Swissmedic by manufacturer incident report.4 Spectacle frames, spectacle lenses and ready-to-wear reading spectacles have until 1 November 2028 for Master UDI-DI assignment, registration and linkage.1

Can anyone see our linked devices in swissdamed?

Partly. All registered device data are public, and the public search also covers registered economic operators, including importers.4,2 Drafts are not public.11 Swissmedic's guides do not describe how an importer link is displayed publicly, so check the public view after linking. Swissmedic has also said it will make device data available for public download by 2027 at the latest.5

Sources

  1. Swissmedic, Importers: obligations of importers in swissdamed (linking, availability since 1 October 2026, transition to 1 April 2027)
  2. Swissmedic, swissdamed – swiss database on medical devices (modules, public search and legal basis)
  3. Swissmedic announcement, swissdamed: As of 1 July 2026, mandatory registration applies to medical devices and in vitro diagnostic medical devices (1 July 2026)
  4. Swissmedic, swissdamed Questions and answers (CHRN, mandates, device registration, importers)
  5. Swissmedic, Webinar swissdamed Swiss Database on Medical Devices, presentation (28 May 2026)
  6. Ordinance of 14 September 2018 on the Fees Levied by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic, SR 812.214.5), Art. 4, Art. 13a and Annex 2, Fedlex (official German text; version in force from 1 July 2026)
  7. Medical Devices Ordinance of 1 July 2020 (MedDO, SR 812.213), Articles 51, 53, 54 and 55, Fedlex (version in force from 1 July 2026)
  8. Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219), Articles 46 and 48, Fedlex
  9. Swissmedic, Information sheet: Obligations Economic Operators CH (MU600_00_016, version 7.0, valid from 1 May 2026)
  10. Swissmedic, Information sheet: Medical device registration fee (BW630_40_001, version 1.0, valid from 9 July 2026)
  11. Swissmedic, swissdamed User Guide UDI Devices Module (BW630_40_841, version 5.0, 1 October 2026), chapters 4 and 14
  12. Swissmedic, Handbook swissdamed User Guide Actors (BW630_40_001, version 4.0, 1 October 2026), user roles, inactivation and mandates
  13. Swissmedic, swissdamed release notes (version 2.6.0 of 1 October 2026 and earlier releases)
  14. Swissmedic event notice, swissdamed Webinar 10 November 2026
  15. Swissmedic, Registering economic operators (CHRN): format and published actor list

Talk to VEMERIX

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.