Request a quote for
Swiss Authorised Representative

First of all we need to know some of your information.

Company and contact person

Company*This field is required

Full name (first name & family name)*This field is required

Job title*This field is required

Phone number*This field is required

Email address*This field is required

Company particulars

Country*This field is required

Website*This field is required

Person responsible for regulatory compliance, PRRCThis field is required

Product information

We need to know how many Technical Files/Documentation sets and how many GMDN codes (or EMDN codes) you have.

Number of Technical Files/Documentation sets*This field is required

Number of GMDN codes

Class I devices (non-sterile, non-surgically reusable, and without measuring function)*

Class Is/Ir/Im devices (either sterile or surgically reusable, or with measuring function)*

Class IIa devices*

Class IIb devices*

Class III devices* (please note that Decomplix only offers Swiss Representative services for Class III devices on a case-by-case basis)

URL to EU/EC declaration of conformity* (or upload file, max size 10mb)Please enter URL or upload file

orBrowse file

URL to Labeling* (or upload file, max size 10mb)Please enter URL or upload file

orBrowse file

Please note:

Decomplix cannot guarantee acceptance of the mandate. Because the Swiss Rep is jointly and severally liable with the manufacturer for defective products, Decomplix subjects the acceptance of the Swiss Rep mandate to a preliminary verification of compliance of the medical devices, which encompasses the review of its technical documentation.
Decomplix cannot guarantee to take over the mandate, as regular clients have priority.

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