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We support you as CH-REP:

(swiss authorized representative)

To comply with legal and normative regulations

To gain approval for medical devices, sold in the Swiss healthcare market

In the communication with the Swiss authorities

To our Services

A brief guide to SMQS

Under observance of the applicable legal requirements, Swiss Medical Quality Services “SMQS” assists international manufacturers to gain the necessary approval to place their devices on the Swiss market.

As a Swiss authorised representative (CH-Rep), we are acting on the manufacturer’s behalf, “SMQS” assumes responsibility for the formal and safety-related issues connected with placing the device on the market.

“SMQS” provides comprehensive services, which includes assistance with the device registration process, compliance and cooperation with the authorities in respect of all Field Safety Corrective Actions (FSCA).

Our customers are well-established Swiss and foreign companies with decades of experience in the Swiss medical and dental markets.

Market access for medical devices in Switzerland

The Mutual Recognition Agreement (MRA) between the EU and Switzerland was not updated in May 2021. As a result, cooperation between the Swiss and EU authorities on medical devices has been suspended. Switzerland is treated as a third country in respect of medical devices (MDR products) and In-vitro-Diagnostic Devices (IVDR-products).

Consequently, the Swiss market surveillance authority Swissmedic no longer has access to EUDAMED and market surveillance data from the EU.

The Swiss Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) therefore sets out additional measures to ensure that Switzerland is able to monitor foreign medical devices within Switzerland. The requirements in this regard are equivalent to those of the EU Regulations on medical devices (MDR) and In-vitro-Diagnostic Device Regulation (IVDR). Amongst other things, the Ordinance stipulates the appointment of an Authorised Representative in Switzerland and an appropriate labelling of the imported devices.

If the device manufacturer does not have its registered place of business in Switzerland, its devices may only be made available to the Swiss market once an Authorised Representative domiciled in Switzerland has been designated (CH-Rep)

Swiss Authorised Representative (CH-REP) – Definition according to Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO)

If the device manufacturer does not have its registered place of business in Switzerland, its devices may only be placed on the Swiss market once an Authorised Representative domiciled in Switzerland has been mandated in writing (Art. 51, para. 1 MedDO / Art. 44, para. 1 IvDO). This also applies to manufacturers with their registered place of business in the European Union. Source: Market access (swissmedic.ch)

“SMQS” provides you with comprehensive Swiss Rep services including advising and assisting you in the implementation of the measures required for your medical device (e.g., labelling, adaptation of documentation).

Our offer

Registration

SMQS assists manufacturers to gain necessary approval for medical devices on the Swiss market

Labeling

SMQS assesses whether medical device labelling and markings conform with requirements

Compliance

SMQS assumes responsibility for compliance with the statutory provisions governing the placing of medical devices on the market

Experience

SMQS is trusted by well-established Swiss and foreign companies in the medical and dental markets

Vigilance

SMQS fulfils reporting obligations and cooperates with the authorities in respect of all Field Safety Corrective Actions (FSCA)

Partners

SMQS is trustworthy, and all information and documentation from its partners are treated confidentially

Contact us!

    SMQS by Arnold Bott AG
    Industriestrasse 59
    8152 Glattbrugg

    Phone: +41 44 828 62 60
    Fax: +41 44 828 62 61

    info@smqs.ch
    info@arnoldbottag.ch

    CHRN-AR-20001948

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