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THE MINISTRY OF HEALTH 2692 Pursuant to Article 64, paragraph 2 of the Medical devices Act (Official Gazette 76/2013), the Minister of Health hereby issues the ORDINANCE ON MONITORING ADVERSE INCIDENTS
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Who needs ordinance-on-monitoring-adverse-incidents-related-to-medical-devicesm-15-enpdf:
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Medical institutions and healthcare facilities that use medical devices are required to have access to this ordinance.
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Regulators and government agencies involved in monitoring adverse incidents related to medical devices may require this document.
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Manufacturers, distributors, and vendors of medical devices may need to refer to this ordinance to ensure compliance and address any adverse incidents that arise.
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It is a document outlining the procedures for monitoring adverse incidents related to medical devices.
The healthcare facilities and manufacturers of medical devices are required to file the ordinance.
The form must be completed with details of the adverse incidents and submitted according to the guidelines provided.
The purpose is to ensure that all adverse incidents related to medical devices are properly monitored and reported.
Details of the adverse incidents, including date, description, and any actions taken in response.
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