According to Medical Devices Ordinance (MedDO) Article 104a, several transitional periods for the nominee of the Swiss Authorised Representative CH REP have been established based on the device risk class.
The deadlines are given below:
- Within December 31, 2021, for Class III devices, Class IIb implantable devices, and active implantable Medical Devices.
- Within March 31, 2022, for Class IIb non-implantable devices and Class IIa devices.
- Within July 31, 2022, for Class I devices.
Also, according to MedDO, Article 51, subparagraph a Swiss Authorised Representative CH REP for procedural kits and systems has to be designated by July 31, 2022.
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