Your current (or future) medical device distributor has obligations to comply with.
The medical device market is highly regulated, and you need to ensure your distributor, who will be your representative in the country, acts according to Swiss regulations.
To sustain a good image among healthcare professionals and retain access to the Swiss market, it's crucial to check that your distributor meets the legal requirements.
This article will describe where to find the legislation, the essential points to verify, how to do it, and where to find Swiss medical device distributors.
How is regulated the Swiss medical device distribution?
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. You can find the up-to-date regulation on the Swissmedic website and, more specifically, the webpage dedicated to the obligations.
The Swiss medical device regulation defines 5 main operators, 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.
For more information on the role of a CH-REP, you can check our dedicated blog post on our website.
What is the role of a Swiss medical device distributor?
As stated above, a Swiss medical device distributor could endorse multiple operator roles in the eyes of Swiss law. In this paragraph, we will consider that he is not the CH-REP but endorses only the importer and distributor roles. We will also split the obligations by role to make it simpler.
The role of the Swiss medical device importer
The Swiss Ordinance says that an importer is: "not "designated", its role arising instead from the activity that is carried out when a natural or legal person in Switzerland places a device from another country on the Swiss market.”
The Swiss importer will be the operator importing the product from the foreign manufacturer to place it available in the Swiss market. It does not mean the Importer operator sells and makes it available to healthcare professionals (end-users). It is the operator who has imported the medical device from abroad.
The medical device importer is "placing on the market" the products. It's the "first making available of a device on the Swiss market."
The transfer can occur between an importer and a distributor or an importer and a healthcare professional. It refers to "each individual device, not to a type of device. Consequently, each individual device is placed on the market even if devices of the same model or type have already been placed on the market."
The role of the Swiss medical device distributor
The Swiss Ordinance says that a distributor is an "economic operator in the supply chain (other than the manufacturer or the importer) that makes a device available on the Swiss market, up until the point of putting into service.”
To specify the terms, the Ordinance says that “making available on the market" is a "collective term referring to the transfer or supply of a device." It "supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right concerning the product" and that "the transfer does not necessarily require the physical handover of the product" but "can be for payment or free of charge."
Finally, the Swiss medical device distributor could be the operator in charge of "putting into service" the devices. Which is defined as "the stage at which the device is made available to the final user/healthcare facility for the first time."
Obligations and requirements for Swiss medical device distributors
Swiss medical device importers and distributors must respect obligations and fulfill requirements towards the foreign manufacturer and Swiss authorities (i.e., Swissmedic).
In this example, we consider that the foreign manufacturer of medical devices has appointed a third-party company to assume the role of CH-REP.
Here are the mandatory obligations and also additional points of importance for the Swiss importer-distributor:
- Only placing devices on the market devices that comply with MedDO or IvDO regulations
- Have a written mandate and contract with the manufacturer
- Keeping a copy of the Declaration of Conformity and Certificates for up to 15 years (depending on the device's nature)
- A person in charge of regulatory compliance in the organization
- Being registered as an economic operator and providing its CHNR registration number to the manufacturer
- Formal verification of the device and labeling before placing it on the market
- In case of incidents or non-conformities, informing the manufacturer, the importer, and the CH-REP (authorized representative)
- Ensure full traceability of the medical devices
- Ensure proper storage and transport
- Registration and Forwarding of complaints and reports to the manufacturer, the importer, and the CH-REP
- Keeping a register of complaints, non-conforming devices, recalls, and withdrawals
- Cooperation with Swissmedic and the whole supply chain in case of investigations of complaints
- Assisting in corrective actions in the market
The CH-REP will be in charge of the relationship with Swissmedic; this is why you need to have a competent CH-REP and to ensure the relationship between the CH-REP, the importer, and the distributor is optimal.
For more accurate and up-to-date information on the importer and distributor obligations, please check the Swissmedic website.
Ways to control the obligations of your Swiss medical device distributor
Visit their premises
It's a simple act, but it is worth spending time on it. You must visit the importer and distributor premises before you select a medical device importer and/or distributor and during your ongoing business relationship. It will help you detect their deficiencies and support them in overcoming shortcomings. Print the list of requirements they need to meet and ask how they comply. In case of shortcomings, require your business partner to find and implement a solution in a given timeframe.
Ask for reports and control regularly
Even if you don't have time to visit them, ask your distributor to show their registers for Declaration of Conformity, incidents, complaints, etc. It's about making them accountable for their role and proving they are the professional partner you sought to represent your brand in the country.
Mandate a third-party company to audit your distributor
There are third-party companies that can assume the role of CH-REP. Some third-party companies can run audits at your importer-distributor's premises to verify that they comply with Swiss law. You would be surprised at the results. Saying that we comply 100% with the law is very different than complying with the law. Running an audit from time to time would help your business and the business of your distributors.
If you would like to be introduced to a third-party company to run audits at your Swiss medical device distributor's premises, we'll be happy to do so.
Where can you find medical device distributors in Switzerland?
You can find medical device distributors in many places. Where we tend to identify the most efficient distributors for our clients are:
- at Swiss tradeshows
- on online directories
- with thorough desk research in the native languages
- by networking with industry associations, CH-Reps, and other valuable contacts in the industry
If you wish to have more information on how to find a Swiss medical device distributor, we wrote a dedicated article on the process and methods to find one in Switzerland.
In conclusion, as a medical device manufacturer wanting to enter the Swiss market, choosing a reliable distributor meeting legal requirements and obligations is crucial. The Swiss medical device market is highly regulated, and understanding the roles and responsibilities of each operator in the supply chain is essential to comply with Swiss law. By verifying that your distributor follows the MedDO or IvDO regulations and fulfills their obligations, you can ensure that your medical device maintains a good image among healthcare professionals and retains access to the Swiss market.
Our company, Masson International, specializes in finding medical device distributors in Switzerland. We identify, qualify, and introduce the best medical device distributors to our clients.
Disclaimer: We are not specialists in this regulatory matter; therefore, we cannot be sued for wrongful information or harm. Please check with experts and local authorities for up-to-date information.
