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Swiss Importer

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Swiss Importer

Swiss Importer

When a medical device manufacturer is domiciled outside Swiss, the manufacturer needs to appoint importer from Swiss to place a medical device in Swiss market. An importer is a natural or legal person in Switzerland that places a device from a foreign country on the Swiss market. An importer must be registered with Swissmedic

Art 53 MedDO

A Swiss Importer shall perform the following task specified in the agreement between it and the manufacturer

In absence of the MRA, this role also applies to the devices from the EU/EEA.
Swiss Importers must print their name, place of business, and contact address on the product, product packaging or on a document enclosed with the product.
If there is any doubt about the conformity, importer must not place the device on the market.
To comply with storage, transport, and quality management system.
To co-operate with the manufacturer, authorised representative, designated body and competent authorities.
To immediate forward complaints and reports about suspected incidents to manufacturer, if applicable to authorised representative.
To register complaints, non-conforming devices, re-calls, and withdrawals (keep a complaints list).
To assist with Corrective actions / Preventive actions i.e, implementation of corrective actions (including recalls).
To retain documents for a period of 10 years and 15 years for implantable devices after the device was placed on the market.
There will be no enforcement of the labelling for Swiss importers until July 2022.
  • Before placing the device on the market, the importer shall verify the following documents:
  • The device carries Conformity marking.
  • The product is labelled in accordance with its ordinance.
  • Accompanied by IFU (3 official languages of Swiss).
  • UDI assigned.
  • The manufacturer is identified and that an AR is designated.
  • The Declaration of Conformity has been drawn up.
  • According to the transitional provisions specified in art 101 paras 1 and 2 in MedDO, MDD compliant devices may be placed on the market after 26 May 2021 if the following provisions of MDR are fulfilled:
  • PMS is ensured for these devices.
  • Vigilance required.
  • Economic operators registered
  • Timelines for registration of Swiss Importer:
  • DR Devices
  • Product placed on the market for the first time after 26.05.2021: Importers must registration within 3 months.
  • Product placed on the market for the first time before 26.05.2021: Importers must registration by 26.11.2021.
  • MDD/AIMDD Devices
  • Product placed on the market for the first time after 26.05.2021: Importers must registration within 3 months.
  • Importers that have placed devices on the market for the first time before 26.05.2021: no obligation.

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