Art. 16 – Application

Art. 16

Application

The sponsor shall submit the application documents specified in Annex 1 number 2.

Swissmedic may request additional information.

If the sponsor withdraws its application for conformity-related clinical trials in sub-categories C1 and C2 before Swissmedic has made a decision, it shall inform the contracting states in which the clinical trial is being conducted or is due to be conducted.

Legal act context: SR 810.306 · CTO-MedD · Ordinance · Ordinance of 1 July 2020 on Clinical Trials with Medical Devices (CTO-MedD)

Structure path: Chapter 2 Approval and Notification Procedures Section 3 Approval Procedures to be performed by Swissmedic

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Data status: 2025-05-20

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Art. 16

Application

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