Importers and distributors of medical devices are obligated to maintain a register of all notifications, complaints, and incidents received from entities to whom they have supplied devices, as well as complaints reported by patients and users directly. This information should be shared with the manufacturer, authorized representative, importer, or other distributors to facilitate their review and implementation of corrective measures. Additionally, the data should be made available to the  authorities.
Non-compliance with the requirements for documenting complaints and notifications may result in fines.
Our team is here to assist you in managing complaints and gathering feedback from the market