For foreign manufacturers that do not have a registered office in the territory of the Republic of Serbia, we offer a complete service for appointing an Authorized Representative of the manufacturer (Local Representative / MAH) in accordance with the Law on Medical Devices of the Republic of Serbia.
Continuous communication and representation before ALIMS and the Ministry of Health.
Appointment of the Person Responsible for Documentation (LOD) and the Person Responsible for Vigilance (LOV).
Assuming legal and regulatory responsibility for maintaining the valid status of your medical devices in the ALIMS Register.
Rapid response in cases of field safety corrective actions (FSCA), product recalls, or reporting of unexpected adverse reactions.
Our team consists of experts with many years of experience working with ALIMS, the Ministry of Health, and professional bodies in Serbia.
We reduce the risk of application rejection and shorten the time required for products to reach the market.
We provide support from the initial idea and compliance assessment, through certification and registration, to post-market surveillance.
Contact us for consultations and the preparation of an offer tailored to your business needs.