Request an offer for your SWISS-REP
As an experienced and competent company with many years of activity in Switzerland, we offer you the opportunity to act as the Swiss authorized representative for your products.
We are happy to offer you the SWISS-REP service. We are an established consulting company that has been working in Switzerland for clients in the medical device industry for 10 years.
0041 (0)76 371 09 77 We advise and call you back immediately free of charge.
Contact us non-binding.
If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU.
The binding deadlines can be found in the next section:
December 31, 2021: Class IIb and III
March 31, 2022: Class IIb and IIa
July 31, 2022: Class I
July 31, 2022: Systems and treatment units
The deadline means that the papers for the SWISSREP must be complete and compliant by then, this can sometimes take time. Advice: start in good time months in advance, just to be on the safe side.
Swissmedic:
Art. 104a98 Appointment of authorised representatives
If the manufacturer is domiciled in an EU or EEA state, or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods:
a. for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021;
b. for non-implantable class IIb devices and class IIa devices: by 31 March 2022;
c. for class I devices: by 31 July 2022.
(2 For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.
98 Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).)
As an experienced and competent company with many years of activity in Switzerland, we offer you the opportunity to act as the Swiss authorized representative for your products.
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