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]

An 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.

❖ Before placing the device on the market, the importer shall verify the following documents:

• The device carries Conformity marking.
• The Declaration of Conformity has been drawn up.
• The manufacturer is identified and that an AR is designated.
• The product is labelled in accordance with its ordinance.
• Accompanied by IFU (3 official languages of Swiss).
• UDI assigned.

❖ 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

❖ 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.

❖ Timelines for registration of Importer:

• MDR Devices:
(i) Product placed on the market for the first time after 26.05.2021: Importers must registration within 3 months.
(ii) Product placed on the market for the first time before 26.05.2021: Importers must registration by 26.11.2021.
• MDD/AIMDD Devices:
(i) Product placed on the market for the first time after 26.05.2021: Importers must registration within 3 months.
(ii)Importers that have placed devices on the market for the first time before 26.05.2021: no obligation.

❖ There will be no enforcement of the labelling for Swiss importers until July 2022.