CHREP.me
CHREP.me GmbH
Swiss CH-REP & CH-Importer for non-Swiss medical device and IVD manufacturers (Class I–III). Zug-based, PRRC experienced in EU MDR/IVDR and MepV/IvDV, from CHF 99/month.
CHREP.me GmbH, based in Zug, acts as Swiss Authorised Representative (CH-REP) and Swiss Importer (CH-Importer) for manufacturers and distributors outside Switzerland who want to place medical devices (Class I, IIa, IIb, III) or IVDs on the Swiss market under MedDO/IvDO. The service, previously operated under the ch-rep.me brand, has been active with Swissmedic since June 2022 and currently supports around 50 manufacturer and distributor mandates. A Swissmedic-recognised PRRC is in place. Clients get one point of contact for both roles, fixed and transparent monthly fees, support with swissdamed registration, and direct, plain-language answers in English or German.
Facts
Examples & Achievements
CH-REP and CH-Importer mandates for EU and international manufacturers and distributors of medical devices and IVDs since 2022.
More about our services
Scope: CH-REP and/or CH-Importer for medical devices and IVDs placed on the Swiss market. To quote quickly we need your device classification(s), number of devices, current Swiss distribution setup and whether you already have a Swiss representative or importer. Onboarding includes the mandate agreement, a check of documentation availability and swissdamed registration support.
HQ:
Zug, Switzerland
Languages:
English, German
Timezones:
Europe/Zurich
Claim status:
Claimed
Services & Capabilities
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Jurisdictions:
CH
Countries:
CH (Switzerland)
Industries:
Medical Devices, IVD
Portfolio:
1-5, 6-25, 26-100, 100+
Flags:
class_iii, ivd, multi_language_support, fast_onboarding, sterile
Response SLA:
48 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 99
Included services:
Swiss Authorised Representative (CH-REP) mandate under MedDO/IvDO, Availability of technical documentation and Declaration of Conformity for Swissmedic, Cooperation and correspondence with Swissmedic, Vigilance and serious incident reporting support, Field safety corrective action (FSCA) support, swissdamed actor and device registration support, On-demand regulatory consulting (CHF 199/hour), PRRC with long-standing EU MDR/IVDR and MepV/IvDV experience
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
Zug
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
importer_distributor_compliance
Jurisdictions:
CH
Countries:
CH (Switzerland)
Industries:
Medical Devices, IVD
Portfolio:
1-5, 6-25, 26-100, 100+
Flags:
class_iii, ivd, multi_language_support, sterile, fast_onboarding
Response SLA:
48 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 499
Included services:
Swiss Importer (CH-Importer) role under MedDO/IvDO for all device classes and IVDs, Unlimited number of devices per mandate, Importer verification obligations before placing devices on the Swiss market, Importer identification on device/packaging/accompanying documents, swissdamed registration support, Cooperation with Swissmedic, vigilance and complaint handling support, Combinable with CH-REP mandate (single point of contact), On-demand regulatory consulting (CHF 199/hour)
Training Available:
No
Template Pack Available:
No
Deliverables:
Ongoing retainer
Role Coverage:
Importer
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