Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of device economic operators and products (Art. 47 HMG; Art. 17 and 55 MepV)

Switzerland · Swissmedic · Medical devices

Device: registration or licence with the regulatorHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

2 requirements

Application fee

CHF 200

2026

What is the Registration of device economic operators and products in Switzerland?

Manufacturers or their Swiss authorized representatives, and importers, register with Swissmedic before first placing a device on the market and receive a Swiss registration number (CHRN). Since July 2026, devices themselves must also be registered with the agency, with a six-month transition period. Before first placing a medical device or in vitro diagnostic device on the Swiss market.

How much does the Registration of device economic operators and products cost?

The assignment of a swiss registration number (chrn) to an economic operator is CHF 200 for 2026.

What are the steps of the Registration of device economic operators and products?

1. Register the economic operator; 2. Agency checks data and assigns the CHRN; 3. Register the device and its UDI data.

Outcome: Swiss registration number for the operator and a registered device.

Legal basis: Therapeutic Products Act (HMG) Article 47; Medical Devices Ordinance (MepV) Articles 17 and 55; IvDV; Fee Ordinance (GebV-Swissmedic) Annex 2

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Register the economic operatorManufacturer or Swiss representative, and importer, register their data. Changes are reported within one week.
2. Agency checks data and assigns the CHRN
3. Register the device and its UDI data

Requirements

What the applicant must provide or meet

Local presence

Operator registration before first placing on the marketManufacturers or their authorized representatives, and importers, register the required data with the agency before they first place a device on the market.

Other

Unique device identifierThe manufacturer assigns a UDI to the device and higher packaging levels and registers the UDI data with the agency. Custom-made devices are exempt from the UDI.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
Assignment of a Swiss registration number (CHRN) to an economic operatorEstablishment · 2026	CHF 200
First device registration by a manufacturer in a calendar yearProduct · 2026 · Each further registration in the same calendar year costs CHF 20. Registration fees for one manufacturer are capped at CHF 10,000 per calendar year.	CHF 200
Each further device registration in the same calendar yearProduct · 2026	CHF 20

Rule changes

Device registration with Swissmedic in force from 1 July 2026In force, November 20, 2024, effective July 1, 2026

Other routes in Switzerland: Medical device conformity assessment and placing on the market, In vitro diagnostic device conformity assessment and placing on the market, Exceptional authorization of a device without conformity assessment. See all routes on the Switzerland page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.