Updated PDF forms and preliminary information on eGov service

30.06.2017 - In accordance with its strategic IT plan (Annual Report 2011), Swissmedic constantly strives to optimise its processes and extend its platforms. The next step is to digitise the submission of all reports and applications. These include submissions relating to the mandatory notification for the placing of medical devices on the market (according to Art. 6 MedDO), orders for export certificates (Free Sales Certificates) and Clinical Trials applications and reports. The changes will be implemented in stages this year, starting with updated forms for materiovigilance (for users) and the mandatory notification for the placing of medical devices on the market (according to Art. 6 MedDO).

All existing forms will be replaced by PDF forms. These dynamic PDF forms will make it simpler and more user-friendly to enter the required information.

The following forms will be introduced with immediate effect, with a transitional period of 3 months (up to 31.09.17):

Materiovigilance

Mandatory notification for the placing of medical devices on the market (per Art. 6 MedDO)

Further forms will follow over the course of the year.

Preliminary information on eGov service

An eGov service will be available in future for the submission of Clinical Trials, export certificates and applications for exemptions for non-conforming medical devices. Full details on this will be provided in the 3rd quarter of 2017 in this Medical Devices Newsletter.