Swissmedic Guidance: Quality Defect Reporting, Medical Device Registration Fees, and Clinical Investigations with Medical Devices

Sharan Murugan
Jul 20
4 min read

Switzerland's regulatory framework for medicinal products and medical devices places strong emphasis on product quality, effective market oversight, and the safe conduct of clinical investigations. Recent Swissmedic information sheets provide important requirements for pharmaceutical companies, medical device manufacturers, sponsors, investigators, and other stakeholders operating in Switzerland.

This blog provides a concise overview of three Swissmedic information sheets covering Notification of Quality Defects, Medical Device Registration Fees, and Clinical Investigations of Medical Devices.

1. Notification of Quality Defects

The Swissmedic information sheet Notification of Quality Defects outlines the requirements for reporting quality defects associated with medicinal products and active pharmaceutical ingredients (APIs).

A quality defect may arise when a medicinal product fails to meet its authorised specifications, when Good Manufacturing Practice (GMP) deviations occur during manufacturing, or when previously unknown quality issues are identified that could affect human or animal health. Defects may be identified through patients, healthcare professionals, manufacturers, distributors, stability testing, pharmacovigilance activities, or regulatory market surveillance.

Reporting Requirements

Quality defects that could affect the established use, efficacy, or safety of a medicinal product must be reported to Swissmedic. This includes relevant defects involving products marketed or manufactured in Switzerland or Liechtenstein and certain quality issues involving active pharmaceutical ingredients.

Reporting is mandatory for relevant manufacturers, marketing authorisation holders, wholesalers, and healthcare professionals involved in supplying or administering medicinal products. The Qualified Person also plays an important role in ensuring quality defects are appropriately reported and necessary measures are implemented.

The reporting timelines depend on the potential health risk:

Class I: Serious or potentially life-threatening risk – within 24 hours
Class II: May cause illness or incorrect treatment – within 3 calendar days
Class III: No significant health hazard expected – within 15 calendar days

Depending on the risk, regulatory actions may include batch recalls, communications to affected stakeholders, international rapid alerts, GMP/GDP follow-up, or inspections.

2. Medical Device Registration Fee

The Swissmedic information sheet Medical Device Registration Fee describes the fee requirements associated with registering medical devices in the swissdamed database.

From 1 July 2026, medical devices placed on the Swiss market, including in vitro diagnostic medical devices and systems and procedure packs, must be registered in swissdamed. The applicable registration fee is payable by the registering manufacturer or persons assembling systems and procedure packs, or their Swiss authorised representative, where applicable.

Registration and Transition Period

The voluntary swissdamed registration phase operated from 18 August 2025 until 30 June 2026. Mandatory registration became effective from 1 July 2026, with a transition period running until 31 December 2026.

In principle, registration fees apply to devices registered by the end of 2026, including those registered during the voluntary phase. Devices that are no longer placed on the market as of 31 December 2026 and are appropriately marked in swissdamed are not subject to the fee.

Fee Structure

The registration fee includes:

CHF 200 one-time basic fee for the first UDI-DI registered in a calendar year.
CHF 20 for each additional UDI-DI.
Maximum annual registration fee of CHF 10,000 per manufacturer or person assembling systems or procedure packs.

Initial billing begins in January 2027 for applicable devices registered through 31 December 2026. In subsequent years, newly registered UDI-DIs are billed where applicable. Updating an existing registration does not generally trigger a new registration fee.

3. Clinical Investigations of Medical Devices

The Swissmedic information sheet Clinical Investigations of Medical Devices guides sponsors, Contract Research Organisations (CROs), and investigators regarding the approval, conduct, reporting, and regulatory surveillance of medical device clinical investigations.

The framework aims to ensure that investigational devices have reached an appropriate development stage, clinical investigations meet scientific and ethical requirements, and the dignity, health, and safety of participants are protected.

Category A and Category C Investigations

Category A investigations generally involve medical devices that can legally be placed on the Swiss market and are used according to their CE-marked instructions. These investigations require approval from the competent cantonal ethics committee but generally do not require Swissmedic approval.

Category C investigations include non-CE-marked devices, devices used outside their approved instructions, or devices whose use or placing on the market is prohibited in Switzerland. These investigations require approval from both Swissmedic and the competent cantonal ethics committee before initiation.

Approval and Regulatory Oversight

Swissmedic performs a formal validation of new applications within 10 days. During the review, additional information may be requested, and Swissmedic can approve an investigation only after the cantonal ethics committee has granted its approval.

Sponsors must maintain an appropriate quality assurance system covering responsibilities, written procedures, regulatory reporting requirements, personnel qualifications and training, and agreements with external parties.

Safety Reporting and Study Completion

Sponsors have ongoing responsibilities for reporting serious adverse events, device deficiencies, safety measures, modifications, annual reports, and study completion or termination.

Key timelines include:

Reportable SAEs and device deficiencies – 7 days
Safety-related temporary halt or premature termination – 24 hours
Other safety and protective measures – 2 days
Completion of the investigation in Switzerland – 15 days
Final clinical investigation report – generally within 1 year
Final report after interruption or premature termination – within 3 months

Swissmedic may also inspect clinical investigations and the organisations or individuals involved and may suspend or withdraw approvals or impose additional conditions where necessary.

Fees

The Swissmedic fees include:

CHF 5,000 for a regular review
CHF 1,500 for a simplified review
CHF 1,000 for a substantial modification
Additional work may be charged at CHF 270 per hour

Eligible academic sponsors may apply for an 80% reduction of the applicable flat-rate fee.

Together, these requirements support stronger product quality, medical device traceability, clinical research oversight, and protection of patients and clinical investigation participants within the Swiss regulatory framework.