FAQ
On the subject of ...
Market entry
What are the classic topics of Swiss AR Services in the area of Market Access?
- Support in the development of a market access strategy
- Outline the treatment path and calculate the cost consequences
- Finding market figures
Does Swiss AR Services also support pharmaceutical companies?
Is Swiss AR Services also an importer/distributor of medical products?
Can Swiss AR Services answer questions about Market Access briefly and concisely on a day-to-day basis?
Does Swiss AR Services also offer market access services for other countries?
Regulatory issues
What information must be included in the product labeling?
The label therefore contains all essential information such as the name of the product, the manufacturer, the CE mark, the serial number and the intended use. You will also find important warnings, the expiry date and sterility status, if applicable, as well as information on correct storage and instructions for use. This ensures that the product can be used safely and correctly.
Is it possible for healthcare facilities to import medical devices directly from abroad?
What language requirements must be met for medical devices in Switzerland?
Does the CH-Rep have to be visible on the product?
Can I define several CH-Rep for my product?
Labeling
What information must be included in the product labeling?
The product labeling is based on Annex l Chapter lll EU-MDR. In addition, the name and address of the CH-Rep must be listed on the label in accordance with Swissmedic requirements. LINK
Does the CH-Rep have to be visible on the product?
It is not sufficient if, for example, only the shipping unit is labeled. The CH-Rep must be visible on all sales packaging. Whether you adapt the design, label the sales packaging yourself or have your distributor do it for you is irrelevant.
What language requirements must be met for medical devices in Switzerland?
The product information includes labeling and instructions for use. It must be written in the 3 official languages (German, Italian, French).
The product information may also be limited to fewer than 3 official languages or to English, provided that the defined exceptions to MepV Art. 16 are complied with.
Why does Swiss AR Services have to take out additional insurance for the products?
List of means and objects MiGeL
Is the MiGeL binding?
Yes, in the area of compulsory health insurance. The MiGeL is an exhaustive positive list and part of the Ordinance of the Federal Department of Home Affairs (FDHA) on Benefits in Compulsory Healthcare Insurance (Healthcare Benefits Ordinance, KLV).
Does the maximum remuneration amount (HVB) correspond to a product price?
No. The HVB defines the maximum amount that may be reimbursed by compulsory health insurance. If a product is cheaper, the insurance company pays the actual costs. If a product is more expensive, the additional costs are borne by the insured person.
The HVB is the median of the products available on the market, taking into account foreign prices.
How can I change the MiGeL if I do not agree with the content or if items are missing?
The MiGeL also includes foods for special medical purposes (FSMP). Does the ingredient also offer a hand in this area?
Who decides on the MiGeL amendment application?
Where can I get information about changes to the MiGeL?
Are there transitional periods until changes to the MiGeL come into force?
Who assigns the correct MiGeL position to the medical devices?
Can the insurance company refuse remuneration even though a product can be assigned to a MiGeL item?
Yes, provided the product
- is not marketable in Switzerland;
- there is no medical order/prescription;
- the application does not fulfill the WZW criteria -
Effectiveness, expediency, economic efficiency;
- does not correspond to a MiGeL item;
- a limitation excludes remuneration; and/or
- the delivery was made via an unauthorized channel.
Remuneration and tariffs
What areas does Swiss AR Services focus on in the area of remuneration and tariffs?
- Medical devices
- In vitro diagnostics
- Food for special medical purposes (FSMP)
- Services in connection with the products
What are the classic tasks of Swiss AR Services?
- Clarification of whether a product is remunerated or whether remuneration is possible
- Guiding and supporting customers on the path to remuneration for their products
- Remuneration of services in connection with the dispensing of medical devices
Does Swiss AR Services also support pharmaceutical companies?
Can Swiss AR Services answer questions about reimbursement/compensation briefly and concisely on a day-to-day basis?
Is Swiss AR Services familiar with the MiGeL list of means and objects?
Does Swiss AR Services also offer services for obtaining compensation for other countries?
CH-REP
Do I have to mention Swiss AR Services by name in my insurance policy?
Does every single component of a system / treatment center have to be named a CH-Rep?
Do we have to coordinate every design change with Swiss AR Services?
Is it possible for healthcare facilities to import medical devices directly from abroad?
Every healthcare facility is subject to the duty of care and must take all measures that are necessary according to the state of the art in science and technology to ensure that health is not endangered.
Swissmedic recommends that healthcare institutions include a check of conformity with the applicable regulatory requirements in the procurement process for medical devices and that they check and retain evidence of product conformity (declaration of conformity and EC certificates).
Information and assistance for the procurement of medical devices in healthcare facilities:
LINK
Do I have to send Swiss AR Services my complete technical documentation?
Can I define several CH-Rep for my product?

Your key to the Swiss market.
We should talk to each other.
Swiss AR Services AG
Industriestrasse 47
CH-6300 Zug