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Art. 67 Reporting systems in hospitals
1 Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 66 paragraph 4. 2 They must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to Swissmedic. They must supply this person’s contact details to Swissmedic. 3 Records and all documents created under the vigilance quality management system must be retained for at least 15 years. |