How to place a medical device in Switzerland (Regulations)

G

Gargi

#1
#1
Hello Elsmar,:bigwave:

As Switzerland dont come under European Economic Area (EEA) , how medical devices are regulated in this market?
:confused:
I would appreciate a detailed info if possible:applause:

Best Regards,
Gargi
:thanks::thanks:
 
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D

davidbrown

#2
#2
Re: How to place a medical device in Switzerland???

In Switzerland, enforcement on medical devices is conducted by the Swiss Agency for Therapeutic Products, Swissmedic.
 
P

Pads38

Moderator
#3
#3
Switzerland has concluded treaties with EU Member States, EFTA States and Turkey with regard to the mutual recognition of conformity assessments for medical devices (bilateral agreements or mutual recognition agreements - MRAs). The basis for these treaties consists of the application of the European guidelines on medical devices and the European CE mark. The States concerned recognise the certificates issued by the Swiss conformity assessment bodies, and in return, Switzerland recognises conformity assessments carried out by Notified Bodies / Conformity Assessment Bodies in the States in question.

The treaties simplify the mandatory reporting requirements for placing devices on the market, and permit direct distribution from Switzerland to all EU and EFTA Member States and Turkey, without an authorised representative with registered offices in the said countries. In return, companies with registered offices in the countries concerned can distribute compliant medical devices directly to Switzerland.
Click to expand...
From here:
https://www.swissmedic.ch/medizinprodukte/02636/03167/index.html?lang=en

Do check that link as there are further requirements.
 
G

Gargi

#4
#4
Re: How to place a medical device in Switzerland???

davidbrown said:
In Switzerland, enforcement on medical devices is conducted by the Swiss Agency for Therapeutic Products, Swissmedic.
Click to expand...
Thank you David.
I would appreciate if I would get the precise comparison b/w CE and Swissmedic.
What I mean is How exactly it differs forom CE roadmap procedure.
Any help would be genuinely appreciated.

Thank you.
Gargi


Always pass on what you have learned
 
G

Gargi

#5
#5
Hi Pads38,

Thank you for that prompt info.
I appreciate you for time taken to anwer my query.

Thanks
Gargi

Always pass on what you have learnt
 
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