Is a CH-REP mandatory for non-Swiss medical device manufacturers?

Yes. Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to place medical devices on the Swiss market.

How does Switzerland's MDR align with the EU MDR?

Switzerland has largely aligned its Medical Devices Ordinance (MedDO) with EU MDR 2017/745, meaning many technical requirements are equivalent, but Switzerland requires a separate national representative.

Can my EU EC REP also serve as my CH-REP?

No. They are separate legal requirements. Your CH-REP must be a legal entity established in Switzerland.

Does the CH-REP handle Swissmedic device registration?

Yes, most CH-REPs include or offer Swissmedic device registration as part of their onboarding scope. Confirm this when comparing providers.

Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices

Appoint a Swiss CH-REP for Swissmedic medical device registration. Compare annual fees and onboarding from vetted Swiss Authorized Representatives online.

✓ 3 active providers available right now · CHF 1,288 – 1,596

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 1,400	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 1,596	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 1,288	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

billingPeriod (Required)
monthly|quarterly|annual
deviceClass (Required)
I|IIa|IIb|III
deviceFamiliesCount (Required)
min 1
legalEntitiesCount (Required)
min 1
includeSwissmedicLiaisonSupport (Optional)
recurring add-on
buyerNotes (Optional)

🇨🇭

Market

Switzerland

📋

Regulation

Swiss MedDO / MDR-CH

⏱️

Onboarding

5–15 business days

💰

Pricing

Annual retainer

Want to read provider profiles and reviews first? Compare all Swiss CH-REP providers →

How it works

1

Describe your device portfolio

Enter your device class, number of families, and legal entities requiring Swiss representation.
2

Compare CH-REP providers

View annual fees and onboarding scope from vetted Swiss Authorized Representatives.
3

Appoint and register with Swissmedic

Your CH-REP will issue an appointment mandate and guide you through Swissmedic registration.

What is a Swiss Authorized Representative (CH-REP)?

Switzerland is not an EU member state, but it has closely aligned its medical device regulations with EU MDR through the Swiss Medical Devices Ordinance (MedDO). Non-Swiss manufacturers who want to place medical devices on the Swiss market must appoint a Swiss Authorized Representative — commonly called a CH-REP — established in Switzerland. The CH-REP's name and address must appear on device labelling for Swiss market products, and they are the primary point of contact for Swissmedic (the Swiss regulatory authority) on all matters related to your devices.

Swiss MedDO vs. EU MDR: key differences

Switzerland's MedDO largely mirrors EU MDR 2017/745 in its classification rules, technical documentation requirements, and GSPR approach. However, Switzerland is not an EU member state, so EU CE certificates do not automatically grant Swiss market access — a parallel Swiss registration is required. Swissmedic has its own registration database, and the CH-REP is responsible for keeping your entries current. Switzerland has also maintained its own transition timelines that may differ from EU MDR implementation schedules, so your CH-REP should keep you informed of any Swiss-specific deadlines.

How much does a CH-REP cost?

Annual CH-REP fees typically range from CHF 300 for simple Class I device portfolios to CHF 2,500 or more for Class III portfolios with multiple device families. Fees usually cover registration maintenance, Swissmedic correspondence forwarding, and label review support. Rush onboarding for urgent Swissmedic registration deadlines may be available at a premium. On Cruxi Bridge, you see annual pricing instantly based on your device class and portfolio complexity.

Can my EU EC REP also be my CH-REP?

No. The EU Authorized Representative (EC REP) and the Swiss Authorized Representative (CH-REP) are entirely separate legal appointments under different regulatory frameworks. Your EC REP must be established in an EU/EEA member state, and your CH-REP must be a legal entity established in Switzerland. Some regulatory service providers offer both roles through different legal entities, which can simplify administration — but the two appointments must be documented separately and reflected correctly on your device labelling for each respective market.

Frequently asked questions

Is a CH-REP mandatory for non-Swiss medical device manufacturers?: Yes. Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to place medical devices on the Swiss market.
How does Switzerland's MDR align with the EU MDR?: Switzerland has largely aligned its Medical Devices Ordinance (MedDO) with EU MDR 2017/745, meaning many technical requirements are equivalent, but Switzerland requires a separate national representative.
Can my EU EC REP also serve as my CH-REP?: No. They are separate legal requirements. Your CH-REP must be a legal entity established in Switzerland.
Does the CH-REP handle Swissmedic device registration?: Yes, most CH-REPs include or offer Swissmedic device registration as part of their onboarding scope. Confirm this when comparing providers.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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