SMQS GmbH
VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.
VDE is a leading European technology organization focused on innovation, standardization, testing, and certification in electrical, electronic, and information technologies. They advance technology and support the next generation of engineers.
VDE, one of Europe's largest technology organizations, has been a driving force for innovation and technological progress for over 130 years. Uniquely, VDE integrates science, standardization, testing, certification, and application consulting under one roof. The VDE mark signifies the highest safety standards and consumer protection for a century. Dedicated to advancing technology, nurturing future engineers, and promoting lifelong learning, VDE operates globally with 2,000 employees across more than 60 locations. Their network includes over 100,000 honorary experts and 1,500 companies committed to creating a sustainable future. VDE's activities span crucial areas such as AI & Digital Trust, Energy, Health, Mobility, Next Generation, and Standardization. The VDE Publishing House offers electrotechnical safety standards and books, with special discounts for VDE members. They also independently and neutrally test and certify electrotechnical devices, components, and systems worldwide. VDE recognizes scientific commitment through various prizes and awards, honoring both emerging talent and established scientists.
About
**Who they are**
SMQS GmbH is a Swiss entity focused on facilitating market access for medical devices and in vitro diagnostic medical devices (IVDs) within Switzerland. They operate within the regulatory framework established by Swissmedic.
**Expertise & scope**
* Assisting manufacturers, authorized representatives, importers, distributors, and health institutions in placing medical devices and IVDs on the Swiss market.
* Ensuring compliance with applicable conformity assessment procedures for medical devices and IVDs, including those provided free of charge, rented, or used directly.
* Managing notifications to the Swiss Agency for Therapeutic Products as required by specific articles within the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
* Navigating the fee structure associated with notifications to Swissmedic, as outlined in the Ordinance on the Fees of the Swiss Agency for Therapeutic Products (GebV-Swissmedic).
**Reputation / proof points**
* Operates within the Swiss regulatory landscape governed by Swissmedic.
SMQS GmbH is a Swiss entity focused on facilitating market access for medical devices and in vitro diagnostic medical devices (IVDs) within Switzerland. They operate within the regulatory framework established by Swissmedic.
**Expertise & scope**
* Assisting manufacturers, authorized representatives, importers, distributors, and health institutions in placing medical devices and IVDs on the Swiss market.
* Ensuring compliance with applicable conformity assessment procedures for medical devices and IVDs, including those provided free of charge, rented, or used directly.
* Managing notifications to the Swiss Agency for Therapeutic Products as required by specific articles within the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
* Navigating the fee structure associated with notifications to Swissmedic, as outlined in the Ordinance on the Fees of the Swiss Agency for Therapeutic Products (GebV-Swissmedic).
**Reputation / proof points**
* Operates within the Swiss regulatory landscape governed by Swissmedic.
Additional information
For medical devices and IVDs to be placed on the Swiss market, manufacturers and their representatives must ensure that the relevant conformity assessment procedures have been successfully completed. This requirement extends to devices that are distributed at no cost, leased, or utilized directly. Certain medical devices and IVDs are subject to a notification obligation to the Swiss Agency for Therapeutic Products. These notifications incur a fee, as stipulated by the relevant ordinances and the fee schedule for Swissmedic.
Key Highlights
-
Facilitates market access for medical devices and IVDs in Switzerland.
Source
“Manufacturers, authorized representatives, importers, distributors or heath institutions may only place medical devices and in vitro diagnostic medical devices (IVD) on the market, make them available on the market or put them into service when the applicable conformity assessment procedure has been successfully completed.”
-
Manages notifications to the Swiss Agency for Therapeutic Products as per MedDO and IvDO.
Source
“Such notifications according to Art. 18, 19, 53, 54, 103 and 108 MedDO of 1 July 2020 (Medical Devices Ordinance, SR 812.213), or Art 10, 46, 47 and 90 IvDO of 4 May 2022 (Ordinance on In Vitro Diagnostic Medical Devices, SR 812.219), will attract a fee of CHF 300.- per notification according to the Ordinance of the Swiss Agency for Therapeutic Products on its fees (GebV-Swissmedic, SR 812.214.5).”
Certifications & Trust Signals
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Operates under Swiss regulatory framework including MedDO and IvDO.
Source
“Such notifications according to Art. 18, 19, 53, 54, 103 and 108 MedDO of 1 July 2020 (Medical Devices Ordinance, SR 812.213), or Art 10, 46, 47 and 90 IvDO of 4 May 2022 (Ordinance on In Vitro Diagnostic Medical Devices, SR 812.219)”
Buyer Snapshot
Best for
- Manufacturers seeking Swiss market access for medical devices and IVDs
- Entities requiring assistance with Swiss regulatory notifications
How engagement typically works
- Focus on regulatory compliance and market entry
- Facilitation of official notification processes
Typical deliverables
- Guidance on conformity assessment procedures
- Management of notifications to Swissmedic
- Support for market access requirements
Good to know
- Best when dealing with medical devices and IVDs subject to Swiss regulations.
Pricing
Model:
Custom pricing
HQ:
Offenbach am Main, DE
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III
Swiss Local Contact:
Yes
Labeling Support:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
Zug
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Intake → mandate agreement → labeling/documentation check → Swiss workflows live
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Supports MDR
false
Supports IVDR
false
Labeling Support
true
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
true
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