Swissdamed Registry Analysis: 4,554 Swiss Actors and 60,611 Device Registrations
A data-driven analysis of Swissmedic's swissdamed database. We break down actor types, risk classes, legislations, and leading CH-REPs.
Switzerland's medical device market access requirements are undergoing a historic transformation. Following the lapse of the Swiss-EU Mutual Recognition Agreement (MRA) in 2021, Switzerland's regulator, Swissmedic, established swissdamed—the Swiss Database on Medical Devices. While the database has operated on a voluntary basis for the upload of device data, use of the Product Module becomes mandatory on July 1, 2026, with a final transition deadline of December 31, 2026.
Because Swissmedic does not provide a public dashboard or high-level summary of aggregate registry statistics, manufacturers and supply-chain managers must parse individual listings to understand the competitive landscape. To bridge this information gap, MedDeviceGuide conducted a comprehensive quantitative analysis of the live swissdamed database extract dated June 21, 2026. This article breaks down the registration volumes, risk classifications, legislative structures, and the leading Swiss Authorized Representatives (CH-REPs) dominating the market.
For a detailed walkthrough of the registration process and grace periods, see our companion swissdamed mandatory July 2026 guide. For the step-by-step pathway to clear products, consult the Swissmedic medical device registration guide.
How Many Economic Operators Are Registered in the swissdamed Actor Module?
The swissdamed Actor Module tracks the economic operators authorized to manufacture, import, or represent medical devices and in vitro diagnostics (IVDs) in the Swiss market. Every operator must secure a Swiss Single Registration Number (CHRN).
As of June 21, 2026, the registry contains 4,554 registered Swiss actors. Of these, 4,075 (89.5%) are in active ("REGISTERED") status, while 479 (10.5%) are marked as "INACTIVE."
Analyzing the active and inactive operator database by role reveals the following distribution:
| Actor Role | Count | Share (%) | Description |
|---|---|---|---|
| Importers (IM) | 2,311 | 50.7% | Swiss-based distributors and logistics companies bringing devices into Switzerland |
| Authorized Representatives (AR) | 1,345 | 29.5% | Domiciled representatives (CH-REPs) acting for foreign manufacturers |
| Manufacturers (MF) | 814 | 17.9% | Swiss-based device and IVD developers |
| System & Procedure Pack Producers (PR) | 84 | 1.8% | Assemblers of combined kits and surgical packs |
| Total | 4,554 | 100.0% | All registered operators |
Source: MedDeviceGuide analysis of Swissmedic swissdamed actor registry, June 21, 2026.
Geographic Concentration
Geographically, 4,530 registered actors (99.5%) are established in Switzerland (CH). The remaining 24 actors (0.5%) are located in Liechtenstein (LI). Under the long-standing customs union treaty and bilateral agreements between Switzerland and Liechtenstein, Liechtenstein-based economic operators are fully recognized within the Swiss regulatory system and register directly in swissdamed.
The fact that importers (2,311) and authorized representatives (1,345) outnumber domestic manufacturers (814) by a ratio of nearly 4.5 to 1 highlights the Swiss medical technology market's high reliance on foreign supply chains.
What is the Breakdown of Registered Swiss Devices by Risk Class and Legislation?
The swissdamed Product Module contains 60,611 UDI-DI device registrations (unique device identifiers at the device level). Our analysis categorized these registrations by their applicable regulatory legislation and risk classifications to understand the composition of products entering the market.
Device Registrations by Applicable Legislation
Swissmedic accepts registrations under both modern European regulations (MDR and IVDR) and legacy directives (MDD and IVDD) for devices covered by valid transition certificates.
- MDR (Medical Device Regulation): 56,249 registrations (92.8% of the registry)
- MDD (Legacy Medical Device Directive): 1,843 registrations (3.0% of the registry)
- IVDD (Legacy In Vitro Diagnostic Directive): 1,374 registrations (2.3% of the registry)
- IVDR (In Vitro Diagnostic Regulation): 1,145 registrations (1.9% of the registry)
The overwhelming dominance of MDR-compliant registrations (92.8%) suggests that manufacturers targeting the Swiss market have rapidly modernized their technical files to meet the newer EU standards. Conversely, the low volume of IVDR registrations (1.9%) reflects the slower transition timeline for diagnostics in Europe, with legacy IVDD products still making up a larger share of active diagnostics listings (2.3%).
Device Registrations by Risk Classification
Breaking down the 60,611 device registrations by risk class reveals that lower-risk, high-volume products represent the majority of entries.
| Risk Classification | Count | Share (%) | Typical Product Examples |
|---|---|---|---|
| Class I | 38,767 | 64.0% | Compression garments, manual surgical instruments, corrective spectacles |
| Class IIa | 13,996 | 23.1% | Hearing aids, dental fillings, ultrasound probes |
| Class IIb | 5,021 | 8.3% | Infusion pumps, ventilators, orthopedic bone screws |
| Class III | 308 | 0.5% | Pacemakers, structural heart valves, drug-eluting stents |
| Class A (IVDR) | 847 | 1.4% | Specimen receptacles, general culture media |
| Class B (IVDR) | 241 | 0.4% | Pregnancy self-tests, clinical chemistry reagents |
| Class C (IVDR) | 57 | 0.1% | Cancer companion diagnostics, blood glucose strips |
| Legacy IVD Categories | 1,374 | 2.3% | List A, List B, and general self-testing IVDs under IVDD |
| Total | 60,611 | 100.0% | All registered UDI-DI records |
Source: MedDeviceGuide analysis of Swissmedic swissdamed UDI-DI database, June 21, 2026.
Class I devices represent 64.0% of the database. This concentration is heavily driven by large-scale domestic registrations of medical textiles and accessories. For instance, Swiss manufacturer SIGVARIS AG alone accounts for 21,682 device registrations in the registry (35.8% of all registrations), representing their extensive catalog of size, color, and compression variants.
Who Are the Leading Swiss Authorized Representatives (CH-REPs) by Registration Volume?
For foreign manufacturers exporting to Switzerland, appointing a Swiss Authorized Representative (CH-REP) is a mandatory market-access requirement. The CH-REP's name must appear on the device labeling, and they assume joint legal liability for product compliance in Switzerland.
Our analysis shows that 29,291 device registrations (48.3% of the total) are registered directly by Swiss-based manufacturers or domestic brand owners. The remaining 31,320 device registrations (51.7%) are managed on behalf of foreign manufacturers by designated CH-REPs.
A small group of commercial CH-REP organizations manages the vast majority of these foreign device listings:
| Rank | Swiss Authorized Representative (CH-REP) | Device Listings | Key Represented Manufacturers |
|---|---|---|---|
| 1 | Nobel Biocare Services AG | 4,777 | Nobel Biocare AB (Sweden) |
| 2 | Share Info Suisse GmbH | 3,593 | Various international medical brands |
| 3 | LymphCare by Cate Rickenbacher Cocola | 2,071 | Macom Malhas de Compressão Ltda. (Brazil) |
| 4 | B. Braun Medical AG | 1,786 | Aesculap AG (Germany), B. Braun group |
| 5 | EUmediq AG | 1,461 | GCE s.r.o. (Czech Republic) |
| 6 | CMC Medical Devices GmbH | 1,418 | Various global orthopedic and dental brands |
| 7 | Arazy Group Swiss GmbH | 1,336 | Various active implantable and digital health brands |
| 8 | MedEnvoy Global B.V., Zweigniederlassung Zug | 1,189 | Multi-national cardiovascular and diagnostic developers |
| 9 | Kessler SA (Laboratoire d'Analyses Médicales) | 1,131 | DIRUI INDUSTRIAL CO., LTD. (China) |
| 10 | ALTRION Sagl | 1,044 | Various dental and active medical device builders |
Source: MedDeviceGuide analysis of Swissmedic swissdamed UDI-DI database, June 21, 2026.
Strategic Implications of CH-REP Concentration
The concentration of registrations within a few commercial CH-REP providers highlights a critical supply-chain risk for foreign manufacturers. Commercial entities like Share Info Suisse, CMC Medical Devices, Arazy Group, and MedEnvoy manage thousands of device listings.
Should one of these major representatives face a Swissmedic regulatory audit that reveals systemic non-compliances, or should they fail to maintain registration upkeep, a large volume of foreign device listings could face immediate suspension. Foreign manufacturers should evaluate CH-REPs not only on upfront cost but on their technical capability, insurance coverage, and regulatory track record. For more on representative selection and pricing benchmarks, see our CH-REP representative pricing guide.
Data Integration: XML Mapping and EUDAMED Synergy
Because swissdamed was built to align closely with the European Union's EUDAMED database, Swissmedic has maintained identical data structures for most device identification fields. This architectural symmetry has critical operational benefits for manufacturers managing large-scale device portfolios:
- Prerequisite Sequence: Device uploads can only occur after Actor registration is fully approved by Swissmedic and a Swiss Single Registration Number (CHRN) is issued. Foreign manufacturers cannot begin UDI-DI mapping until their appointed CH-REP has linked their CHRN to the representative's account.
- Reusable Data Mapping: The XML payloads used for bulk device uploads in EUDAMED are highly compatible with swissdamed. While there is no direct synchronization between EUDAMED and swissdamed—requiring completely separate submission runs—companies can reuse their existing EUDAMED data schemas and mapping profiles to format Swiss uploads.
- M2M Upload Strategy: For organizations with hundreds of SKUs, manually entering data into the swissdamed portal is inefficient. Employing machine-to-machine (M2M) transfer protocols using standardized XML structures is essential. This bulk-upload strategy was critical for high-volume domestic manufacturers (like SIGVARIS AG) and major foreign dental and orthopedic implant providers to populate the database before the July 2026 mandate.
Understanding swissdamed Device Fees and Compliance Timelines
A critical commercial change accompanying the swissdamed mandate is the introduction of Swissmedic's registration fee model.
Under Swissmedic’s updated fee schedules, device registrations are subject to an annual fee structure based on the count of active UDI-DIs in the Product Module.
- First registered device (UDI-DI): CHF 200 per year.
- Each additional registered device (UDI-DI): CHF 20 per year.
- Annual Cap: Capped at CHF 10,000 per manufacturer (or system producer) per year.
The annual cap is reached at exactly 491 devices (CHF 200 + [490 × CHF 20] = CHF 10,000). For manufacturers with extensive SKU listings (such as orthopedic implant lines, dental screw variations, or catheter size curves), the fee will lock at the CHF 10,000 ceiling.
Important Commercial Considerations:
- Fee Calculation Date: Swissmedic assesses the registration fee based on the number of UDI-DIs with the status "On the market" as of December 31 of each calendar year.
- Invoicing Method: Swissmedic expects to issue the first annual invoices in January 2027 to cover registrations active during the 2026 transition.
- CH-REP Invoicing: For foreign manufacturers, Swissmedic issues the invoice directly to the designated CH-REP. The CH-REP is legally responsible for paying the regulator and will pass the fee (often with an administrative markup) back to the foreign manufacturer.
- Portfolio Hygiene: To avoid paying recurring annual fees for obsolete products, manufacturers should proactively change the status of older, discontinued UDI-DIs to "No longer placed on the market" before December 31 of each year. Device entries marked as discontinued do not incur the renewal fee.
Frequently Asked Questions (FAQ)
Can foreign medical device manufacturers register directly in swissdamed?
No. Foreign manufacturers (including those based in the European Union or the United States) cannot create direct user accounts in swissdamed to register devices. Under the Swiss Medical Devices Ordinance (MedDO), foreign manufacturers must appoint a Swiss Authorized Representative (CH-REP) established in Switzerland. The CH-REP must register their own actor profile first, after which they can register the foreign manufacturer's devices under their representative account.
What proportion of registered swissdamed devices are imported vs domestic?
Our analysis indicates that 48.3% (29,291 devices) are domestic or direct registrations, which do not require a CH-REP because the registering company is established in Switzerland or Liechtenstein. The remaining 51.7% (31,320 devices) are imported and managed by Swiss Authorized Representatives (CH-REPs). This demonstrates that more than half of the medical devices registered in Switzerland depend directly on international manufacturing and authorized representation.