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Swissmedic · Europe

Switzerland medical device regulatory resources

Every Switzerland dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

8 free resources23/25 topics with records10 regulations trackedAug 2026 fees reviewed
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Everything we track for Switzerland

Medical device regulations

Browse official Swissmedic regulations and guidance documents.

Government registration fees

Review current Swissmedic application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely Swissmedic pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent Swissmedic policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary Swissmedic risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Switzerland requirements.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

See which Swiss steps carry a statutory deadline and why the conformity assessment itself does not.

Structured regulatory requirements

Explore all 44 source-linked facts →

23 of 25 research dimensions currently covered · 13 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
Swissmedic (Swiss Agency for Therapeutic Products; in the Therapeutic Products Act 'das Institut', Schweizerisches Heilmittelinstitut, TPA Art. 4) is the competent authority for medical dev…
1 source-linked fact
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
IvDO entry into force
The Ordinance on In Vitro Diagnostic Medical Devices (IvDO/IvDV, SR 812.219) of 4 May 2022 entered into force on 26 May 2022, except Art. 16(5) and Art. 90(2), which enter into force at a l…
Implantable Class III custom-made transition
Implantable Class III custom made devices (Sonderanfertigungen) may be placed on the market until 26 May 2026 without a certificate from a Swiss designated body or an EU/EEA notified body,…
7 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
IVD definition
An IVD is a medical device under Art. 3(1) (2) MedDO that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, intended by th…
Medical device definition
Medical devices are instruments, apparatus, equipment, software, implants, reagents, materials or other articles intended by the manufacturer for use in humans whose principal intended acti…
2 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
MedDO classes I, Is, Im, Ir, IIa, IIb and III.
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Economic operator registration and CHRN
Manufacturers and their authorised representatives and importers must register their data (per Annex VI Part A Section 1 EU MDR) with Swissmedic within three months after first placing a pr…
Device registration in swissdamed
Registration of devices, systems and procedure packs (Art. 108 MedDO) in swissdamed becomes mandatory on 1 July 2026 and replaces the previous notification obligation; a transition period r…
3 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
China NMPA approval: no recognition regime
statement: Switzerland recognises only the EU CE conformity route (unilateral recognition of CE marked devices under the MedDO/IvDO); a China NMPA registration certificate gives no route to…
Equal treatment of EU/EEA notified body certificates
Certificates issued by bodies designated under EU law and established in an EU or EEA state that are not recognised through an international agreement are treated as equivalent to certifica…
3 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Local market-entry role (CH-REP)
archetype: manufacturer mandated authorized representative · name: Swiss authorised representative (Bevollmächtigter, CH REP) · required for foreign: yes for foreign manufacturer · legal ba…
Representative or mandate change
path code: swissdamed mandate inactivation and new mandate · mandate recording: mandates are recorded per device in swissdamed Actors (not yet mandatory, but Swissmedic can request publicat…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Importer and distributor controls
Importers may only place compliant products on the market and must verify before doing so: presence of the conformity mark; availability of the declaration of conformity; that the manufactu…
1 source-linked fact
Checked 2026-08-25
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D09

Dossier requirements

Verified
CH-REP technical documentation access
The CH REP must keep a copy of the technical documentation available; alternatively, the manufacturer and CH REP may agree contractually that the manufacturer delivers the documentation dir…
Technical documentation and retention
Technical documentation must be compiled in accordance with Annexes II and III EU MDR and kept available; records must be retained for at least 10 years after the last device covered by the…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
swissdamed actor registration portal
Actor and mandate registration is done in the swissdamed portal (legal basis TPA Art. 62c): access requires CH LOGIN (Swiss federal government login), with Swiss companies verified against…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Label/IFU languages
Product information (labelling and instructions for use) must be in the three official Swiss languages (German, French, Italian); symbols concretised by technical standards may replace lang…
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Manufacturer QMS obligations
Manufacturers' further obligations, in particular the requirements for the quality management system and the risk management system, follow Art. 10 EU MDR as incorporated by reference into…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Swiss medical electrical/EMC evidence
Electrical safety
BAKOM/OFCOM radio market conformity
Wireless / radio
Swiss or accepted CE conformity marking
Wireless / radio
4 maintained overlays
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D15

Review clocks

Unresolved
Class I · Self-declaration (no conformity assessment body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Authorization duration
type: route dependent · description: No Swiss product licence expiry exists for ordinary CE conforming devices (there is no national authorisation procedure); the time limited instrument is…
1 source-linked fact
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Actor data change notification
Changes to registered actor data must be reported to Swissmedic by the economic operator concerned within one week.
Change-control outcomes
outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Registered actor data changes are notified within…
3 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
IVD UDI placement deadlines
IVD UDI affixing deadlines: Class D from 26 May 2023; Classes B and C from 26 May 2025; Class A from 26 May 2027.
MD UDI assignment and placement deadlines
The manufacturer (or system/procedure pack assembler) must assign a UDI to the product, system or procedure pack and all higher levels of packaging before placing on the market (custom made…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evaluation requirement
Demonstration of compliance with the general safety and performance requirements includes a clinical evaluation in accordance with Art. 61 EU MDR (incorporated by reference into the MedDO).
Clinical investigation categories and approval regime
Clinical investigations with medical devices are categorised under KlinV Mep: category A (subcategories A1/A2) — CE marked device used per its instructions for use and not banned in Switzer…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Named-patient supply without authorisation
Individual products that have not undergone the applicable conformity assessment procedure may be placed on the market and used without Swissmedic authorisation if: they serve to remedy lif…
Public-interest exception
On reasoned application, Swissmedic may authorise the placing on the market and putting into service of a specific product in the interest of public health or patient safety or health, even…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Safety update report periodicity
Manufacturers of Class IIa, IIb and III devices must prepare a safety update report (Sicherheitsbericht, PSUR) for each product or product category/group: Class IIa updated as needed and at…
Post-market surveillance system
For every product, manufacturers must plan, establish, document, apply, maintain and keep up to date a post market surveillance system proportionate to the risk class and the type of produc…
2 source-linked facts
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
IVD serious incident and FSCA reporting scope
The manufacturer of an IVD made available on the Swiss market must report to Swissmedic serious incidents in connection with the product occurring in Switzerland, as soon as they become awa…
MD serious incident and FSCA reporting scope
The manufacturer of a product made available in Switzerland, or the person assembling systems or procedure packs and making them available in Switzerland, must report to Swissmedic: (a) ser…
3 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
FSCA notification and field safety notice publication
If a manufacturer or SPPP conducts a field safety corrective action involving devices available on the Swiss or Liechtenstein market, it must notify Swissmedic of the FSCA without delay. Fi…
1 source-linked fact
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising claims restrictions
Advertising of devices may contain exclusively statements consistent with the product information; misleading claims are prohibited; public advertising is prohibited for devices intended ex…
1 source-linked fact
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Administrative procedure and appeal
Insofar as the Therapeutic Products Act does not provide otherwise, administrative procedure and legal protection are governed by the Federal Act of 20 December 1968 on Administrative Proce…
Clinical investigation deficiency procedure
In clinical investigation procedures, the ethics committee confirms receipt of the application within 10 days and notifies formal deficiencies, setting a 10 day period to cure them (with no…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (4 lines) →

Swissmedic registration fees in CHF · reviewed 2026-08-25

Fee lineAmountProvenance
swissdamed Basic Fee - First UDI-DICHF 200Verified
swissdamed Unit Fee - Additional UDI-DICHF 20Verified
swissdamed device registration - first device per yearCHF 200Verified
swissdamed device registration - each additional deviceCHF 20Verified

Registration timeline

Full registration timeline →

Swiss Agency for Therapeutic Products (Swissmedic) review clocks and planning ranges · 4-class (I, IIa, IIb, III) - EU MDR aligned classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no conformity assessment body))0 days3-5 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Switzerland regulation news →

Newest official Swissmedic headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 10SWSwissmedicSwissmedic Issues New Guideline on Swiss Good Practice of Materiovigilance in In Vitro Diagnostics (GPMV-IVD)SwitzerlandSep 1SWSwissmedicNew FAQ on Swissmedic Fees OrdinanceSwitzerlandAug 13SWSwissmedicSwissmedic hospital inspections 2025: supervision having an effect, but action still neededSwitzerland

Key regulations

All 10 Switzerland regulations →

Official Swissmedic rules and guidance · 10 of 10 documents linked to official sources

ClinO-MD (SR 810.306)Ordinance on Clinical Trials with Medical Devices
Clinical TrialsVerified
MedDO Article 26Conformity Certificates and Validity
GMP/QMSVerified
IvDO (SR 812.219)Ordinance on In Vitro Diagnostic Medical Devices
GeneralVerified
IvDO Amendment 2025Amended Ordinance on In Vitro Diagnostic Medical Devices
GeneralVerified
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