与顶尖专家一起确保您的医疗设备符合瑞士法规。

为什么你需要瑞士授权代表？

瑞士不是欧洲联盟成员国，意味着欧盟授权代表在瑞士无效，因此你需要瑞士授权代表。瑞士授权代表负责遵守瑞士法规和法律，且必须在2022年7月31日前任命，以便已经在瑞士市场上的I类医疗器械能够继续在那里的市场上销售。

因此，在瑞士没有注册办事处的医疗器械和IVD制造商现在必须任命当地的瑞士授权代表（CH-REP）。

自2021年5月26日以来，外国医疗器械制造商必须任命一名瑞士授权代表，才能将其产品投放瑞士市场。

CH-REP还可以获得技术文件，并且必须确保产品符合瑞士药品和医疗器械监管机构的要求。

我们还可以帮助您找到合适的销售合作伙伴，在瑞士建立销售网络,并为您接管瑞士的销售。

我们还为您的产品提供服务合同，以确保您的售后服务满足您的需求。

我们可以替你接管这项任务。如果你感兴趣，可以通过微信或钉钉与我们联系。只需扫描下面一个简单的二维码。

如果您是：
IVD和/或MD制造商？

位于瑞士境外？

在瑞士销售您的产品？

您需要瑞士授权代表！

“瑞士医疗器械授权代表”/“CH-REP”是指在瑞士设立的自然人或法人，受国外制造商书面委托，代表其执行某些任务，以履行本条例规定的制造商义务。

Swiss authorised representative (CH-REP)

Ensure Your Medical Device Meets Swiss Regulations With a Leading Expert.

Why Would You Need A CH-REP?

Switzerland is not a member of the European Union. Means a EU-REP isn’t valid vor Switzerland. You need a CH-REP. The CH-REP is responsible for compliance with Swiss regulations and laws and must be appointed by July 31, 2022 so that medical devices of class I that are already on the Swiss market can continue to be placed on the market there.

Therefore, medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative (CH-REP).

Since May 26, 2021, foreign manufacturers of medical devices have had to appoint a Swiss authorized representative in order to be able to place their products on the Swiss market.

The CH-REP also has access to the technical documentation and must ensure that the products meet the requirements of the Swiss regulatory and supervisory authority for medicinal products and medical devices, Swissmedic.

We can also help you to find the right sales partner and setup a sales network in Switzerland. Up to taking over the sales for you in Switzerland.

We also offer service contracts for your products to ensure your after sales service meets your needs.

We can take over this task for you. If you are interested, just talk to us on WeChat or Ding Talk. By just scann simple one of the QR Code below.

If you are:

An IVD and/or MD manufacturer?

Located outside Switzerland?

Selling your products in Switzerland?

You need a Swiss Authorized Representative!

A „Swiss authorized representative for medical devices“ / „CH-REP“ is a natural or legal person established in Switzerland who is commissioned in writing by a manufacturer based abroad to carry out certain tasks on his behalf in fulfillment of the manufacturer’s obligations arising from this ordinance to perceive.