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?
Yes, we also help pharmaceutical companies with questions about medical products. As soon as it comes to medicinal products, we withdraw. "Pharma" is a different world in which we are not at home.
Is Swiss AR Services also an importer/distributor of medical products?
No. Swiss AR Services can help with the search, but does not act as a trading partner itself.
Can Swiss AR Services answer questions about Market Access briefly and concisely on a day-to-day basis?
Yes, we offer a low-threshold service so that a lengthy search can be avoided. Provided the issue in question allows this. The service is billed on an hourly basis.
Does Swiss AR Services also offer market access services for other countries?
No. The services provided by Swiss AR Services relate to the Swiss market. For other countries, the knowledge/understanding required to offer the desired quality is lacking.

Regulatory issues

What information must be included in the product labeling?
The labeling of medical devices is important to ensure safe use. The Swiss requirements are based on MepV Article 16, which in turn refers to Annex I, Chapter III of the MDR.

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?
Yes, that is possible. Healthcare facilities are subject to a duty of care when importing directly. They 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. Only medical devices bearing a valid conformity mark (CE or MD mark) may be used. We are happy to provide assistance.
What language requirements must be met for medical devices in Switzerland?
As soon as a product is available on the free market, the label and instructions for use must be available in all three official languages (German, French and Italian). If the product is sold exclusively to personnel who meet the requirements of MepV Article 16, the label and instructions for use may be limited to one official language or English.
Does the CH-Rep have to be visible on the product?
No, the CH-REP does not have to be directly visible on the product. It is sufficient if the CH-REP is mentioned either directly on the label, on a sticker on the smallest sales unit (or possibly on an accompanying document for MDD products).
Can I define several CH-Rep for my product?
No, a medical device can only have one CH-REP at a time. However, you can designate different CH-REPs for different products.

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?
As we are jointly liable for your products, we must take out appropriate insurance. The insurance depends on the turnover and the risk class. We want to be very transparent with you here and do not charge any flat rates.

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).

Link MiGeL: List of means and objects (MiGeL) (admin.ch)

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?
Changes can only be made by submitting an application. All interested persons and organizations wishing to amend the MiGeL can submit an application.
The MiGeL also includes foods for special medical purposes (FSMP). Does the ingredient also offer a hand in this area?
Yes, the services in terms of clarifying or obtaining compensation are also offered for FSMP products.
Who decides on the MiGeL amendment application?
The Federal Department of Home Affairs issues the MiGeL after consulting the competent committee for analyses, means and objects.
Where can I get information about changes to the MiGeL?
The Federal Office of Public Health offers a newsletter. Ideally, you should subscribe right away so that you are always informed promptly of any changes.
Are there transitional periods until changes to the MiGeL come into force?
The "valid from" date shown for the respective MiGeL item is binding and there is no entitlement to a further transitional period.
Who assigns the correct MiGeL position to the medical devices?
It is the invoicing party's responsibility to apply the correct MiGeL item. It should be noted that there is a prohibition of analogy.
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?
The focus is on remuneration in the Swiss healthcare market of

  • 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?
Yes, we also help pharmaceutical companies with questions about medical products. As soon as it comes to medicinal products, we withdraw. "Pharma" is a different world in which we are not at home.
Can Swiss AR Services answer questions about reimbursement/compensation briefly and concisely on a day-to-day basis?
Yes, we offer a low-threshold service so that a lengthy search can be avoided. Provided the issue in question allows this. The service is billed on an hourly basis.
Is Swiss AR Services familiar with the MiGeL list of means and objects?
Yes, some people also call Rolf Müller, Managing Director, Mr. MiGeL. He is very familiar with MiGeL practice, the structure and the peculiarities of MiGeL.
Does Swiss AR Services also offer services for obtaining compensation for other countries?
No. The services provided by Swiss AR Services are limited to Switzerland. For other countries, the knowledge/understanding required to offer the desired quality is lacking.

CH-REP

Do I have to mention Swiss AR Services by name in my insurance policy?
Not mandatory. It is possible to include Swiss AR Services in your existing insurance, which allows you to benefit from a discount of up to 50% on the insurance position (position 5 in the offer). Contact us today to receive a suitable quote for your product range.
Does every single component of a system / treatment center have to be named a CH-Rep?
No. A CH-Rep must be named for the actual system & treatment unit.
Do we have to coordinate every design change with Swiss AR Services?
No, but Swiss AR Services must be informed of any significant changes to the product itself, as well as to the labeling or accompanying documents.
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?
No, we check some key documents of the technical documentation to ensure that all necessary documents have been prepared. However, the complete technical documentation must be available so that it can be submitted to Swissmedic within 7 days.
Can I define several CH-Rep for my product?
No. You can only mandate one CH Rep per product. However, it is possible to mandate different CH Reps for different products.
SWISS AR SERVICES

Your key to the Swiss market.

We should talk to each other.

Swiss AR Services AG
Industriestrasse 47
CH-6300 Zug