CH-REP = Swiss authorized representative
CH-REP = Swiss authorized representative
Under observance of the applicable legal requirements, Swiss Medical Quality Services “SMQS” assists as CH-REP international manufacturers to gain the necessary approval to place their medical devices (MDR/IVDR) 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.
Bljetar Murati (Quality Manager)
Bljetar has over 10 years of experience in project management and quality management across the MedTech and food industries. In the highly regulated sector, Bljetar supports clients in strategic and regulatory matters, nationally and internationally.
Bernhard Ertel (Managing Director / Compliance)
Bernhard has more than 25 years of experience in the MedTech sector. As a product manager and managing director, he is responsible for sales, project management and close customer relationships. Due to his wide experience in the regulated sector, he supports clients in all matters of quality management and regulatory affairs.
Deepa C. (QM Administration)
Deepa has experience in MedTech and quality management. She handles and coordinates requests from national and international clients and supports them in regulatory matters.
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.
Swiss Authorised Representative (CH-REP)
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).
At “SMQS by Arnold Bott AG”, we specialize in smoothing the path of your products to market while complying with all applicable regulatory requirements.
We also support and advise all manufacturers, importers and distributors in the medical technology industry in the implementation of the applicable regulation in Switzerland.
We are able to do this thanks to our activities in the most diverse areas of medical technology and our proximity to the market. You thus have a strong partner with years of experience in the areas of “Regulatory Compliance, Regulatory Affairs, Quality Management and the national and international regulated environment” at your side!
SMQS assists manufacturers to gain necessary approval for medical devices on the Swiss market
SMQS assesses whether medical device labelling and markings conform with requirements
SMQS assumes responsibility for compliance with the statutory provisions governing the placing of medical devices on the market
SMQS is trusted by well-established Swiss and foreign companies in the medical and dental markets
SMQS fulfils reporting obligations and cooperates with the authorities in respect of all Field Safety Corrective Actions (FSCA)
SMQS is trustworthy, and all information and documentation from its partners are treated confidentially