According to Swiss law, appointing a "CH-REP", a Swiss Authorised Representative, to sell medical and in vitro diagnostic medical devices is now mandatory.
This article will help you understand the legislation, the role and requirements of a CH-REP, and how to find one.
What does the Swiss medical devices legislation say?
The supply chain of medical devices in Switzerland is regulated by The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219). It defines the requirements and responsibilities for operators of the whole supply chain.
Where can you find the Swiss medical device legislation?
The Swiss medical device legislation can be found on the Swissmedic website. Swissmedic is the national authorization and supervisory authority for drugs and medical products. It is responsible for licensing and monitoring therapeutic products. Their mandate is conferred upon them by law. Their main objective is to ensure that the therapeutic products they approve are safe for human and animal consumption. Their mission is to safeguard public health.
To find the Swiss medical device legislation up to date, you can always check the webpage dedicated to medical devices on the Swissmedic website. The information you will find there will always be the latest and most accurate.
Who are the operators in the Swiss medical device market?
There are 5 main operators defined by the Swiss medical device regulation, which are:
- The Manufacturer
- The Swiss authorized representative (CH-REP)
- The Importer
- The Distributor
- The Healthcare institution or professional (i.e., hospital/doctor)
Each of these operators has a specific role. The same entity can endorse multiple roles. For example, the official importer of a medical device could also be the CH-REP and the distributor.
The regulation clearly defines each role in terms of responsibilities and obligations. These could be of various sorts, such as:
- official registration of the entity towards Swissmedic
- verification of the product
- sales tracking
- transportation & storage conditions
- communication & registration of incidents and non-conformities
- etc.
To understand the requirements, roles, and bonds between each operator, Swissmedic has issued a great PDF document with diagrams explaining all of it. You can find it on this specific webpage.
The definition and role of a CH-REP
A Swiss Authorized Representative, a "CH-REP", is a person or company in Switzerland who has been given written permission by a manufacturer from another country to act on their behalf for certain tasks related to the manufacturer's responsibilities in Switzerland.
Medical device manufacturers have certain regulatory obligations in Switzerland that they must fulfill to ensure the safety and efficacy of their products. Because they are located abroad, foreign manufacturers can't fulfill some of them; thus, the Swiss authorities ask them to appoint a CH-REP. The Swiss Authorized Representative will handle a few of these obligations on the foreign Manufacturer's behalf.
It's a mandatory requirement to have a CH-REP if a foreign manufacturer would like to market and sell medical devices in Switzerland.
Obligations of the CH-REP include:
- Registering devices on the Swissmedic database
- Post-market surveillance duties, including preventive or corrective actions
- Verifying Declaration of Conformity and technical documentation
- Checking the labelling requirements
- Complying with Swissmedic requests for documents, samples, or information
- Informing the manufacturer about complaints and incidents in the market
- Reporting to Swissmedic incidents, serious cases, and corrective actions
Foreign manufacturers and Swiss Authorized Representatives need to be careful because some of the responsibilities of the manufacturers can't be transferred to the CH-REP, such as:
- The manufacturer's quality and risk management systems
- The device conformity and Declaration of Conformity
- The manufacturer's post-market monitoring system
- Device labelling
- Etc.
How and where to find a CH-REP?
As we saw previously, a CH-REP could be “any natural or legal person established within Switzerland who has received a written mandate from a manufacturer".
That being said, you - the foreign manufacturer - must select a professional CH-REP with other references in their portfolio and comply with the Swissmedic requirements.
We have encountered medical device manufacturers that wanted to choose the easiest and the cheapest route: selecting an individual or a small distributor to do the job. This isn't a viable solution, in our opinion. The role of CH-REP is very demanding and requires a continuous follow-up of the incidents and the Swissmedic requests and a perfect tracking of documents and information. Moreover, CH-REPs are legally liable to meet the requirements, thus at risk of legal procedures if they don't comply.
The two viable solutions would be to hire your local distributor as CH-REP (not recommended) or to have a third-party company do it on your behalf (the best solution, in our opinion). Selecting a professional third-party company as your CH-REP is more expensive but more convenient and effective. Firstly, because it's their day-to-day job and they have competencies. Secondly, you can part ways with your distributor, which won't affect your Swissmedic registration and obligations toward the Swiss authorities.
If you are interested in the Swiss market, we at Masson International can be a one-stop-shop for your market entry: introducing you to third-party CH-REP companies and finding you a Swiss distributor. For more information, feel free to contact us.
How much a CH-REP service would cost?
Generally, a CH-REP service from a third-party company usually costs CHF 3,000 to 6,000 in the first year. Then, it will be a little less in subsequent years if there are no new products to care for. The pricing always depends on the number of devices to register and the medical device classes they belong to.
CH-REP is an investment-intensive profession, so specialized CH-REP companies charge a high annual fee to do it. CH-REPs generally only agree to take on brands if the company has good CE registrations and the risks of legal problems are controlled. Even if medical devices don't have problems, the Swiss-authorized representative still has to report and track incidents and documents: it's not just a name on a document to fill in.
In conclusion, a CH-REP, or Swiss Authorized Representative, is crucial for foreign medical device manufacturers wishing to sell their products in Switzerland.
The CH-REP acts on behalf of the manufacturer to fulfill regulatory obligations and ensure the safety and efficacy of the devices. From registering devices on the Swissmedic database to reporting incidents and conducting post-market surveillance, the CH-REP plays a vital role in the Swiss medical device market. Selecting a professional and competent CH-REP carefully is important to ensure compliance and avoid legal procedures.
If you are interested in entering the Swiss market, consider partnering with Masson International, which can assist you in finding a CH-REP and a Swiss distributor. Engaging further with these resources will help you navigate the complex requirements and successfully enter the Swiss medical device market.
Disclaimer: We are not specialists in this matter; therefore, we cannot be sued for wrongful information or harm. Please check with experts and local authorities for up-to-date information.
