The Medicines and Medical Devices Agency of Serbia issues an expert opinion on issues within the competences of the Medicines and Medical Devices Agency of Serbia in the field of medical devices. The areas covered by the Request for Expert Opinion are:
• Determining the product status, i.e. determining whether a certain product is a medical device
• Issuing a Free Sale Certificate for a medical device that has been marketed or used in the RS;
• Providing expert advice regarding the translation of instructions for use of a medical device
• Providing expert advice regarding the labeling of medical devices
• Providing expert advice regarding the classification of medical devices into the medical device class and category
• Controlling promotional material for advertising medical devices at the proposal of the Ministry of Health of the RS
• Classification and categorization of medical devices at the request of the Ministry of Health of the RS;
• Providing expert advice regarding the advertising of medical devices (promotional material)
• Information on medical devices (registered medical devices/parallels);
• Regulatory issues;
• Other issues in the field of medical devices;
• Determining the status of a product used for research and development of innovative products.
When submitting a request, an IT solution related to the use of ePortal MS is used. ePortal MS enables the submission of requests and accompanying documentation in electronic form by the client. For doing business through ePortal MS, the client needs to download the Consent for electronic business with the Agency. After the payment has been made, the expert opinion will be drawn up according to the request.