Medical Device Registration in Serbia
For illness prevention, diagnosis, treatment, and rehabilitation of sick Serbians, it is required to provide a wide choice of quality, safe, and effective medical devices to avoid the circulation of low-grade and unregistered products.
The Law on the Production and Trade of Medicines initially regulated medical device production and marketing in Serbia in 1993. Serbia has distributed about 30,000 medical equipment since then.
The 2010 Law on Medicines and Medical Devices requires medical devices to be registered in the Register before being sold in our nation. The Agency for Medicines and Medical Devices of Serbia registers, renews, and updates medical devices in the Register of Medical Devices (ALIMS). ALIMS works with medical device makers, their representative offices, representatives, and distributors, the Commission for Medical Devices, and appointed ALIMS specialists.
The Register of Medical Devices has different procedures for CE-marked and non-CE-marked devices.
Medical devices with a CE mark, which means they were controlled in one of the EU-accredited institutions and comply with EU directives on medical devices, are entered into the Register by an administrative procedure using appropriate certificates and documents.
The Register registers medical devices without a CE mark based on quality, safety, and efficiency testing conducted in our country and in conformity with international standards.
The Register of Medical Devices decision-making process follows Good Regulatory Practice.
For data exclusivity, EU-mandated documentation is stored. Since Serbia is not yet a member of the EU, medical devices are placed on the market with a national approval, a decision to register the device in the Register of Medical Devices, and relevant foreign certificates and documents that prove compliance with EU medical device directives and guarantee quality, safety, and efficiency.
The Law allows ALIMS to authorise the circulation of unregistered medical devices only at the request of specified health institutions to treat life-threatening individuals or groups of patients or for scientific or medical study. ALIMS approves and monitors medical device clinical trials.
The Register of Medical Devices database and lists are published on the ALIMS website.
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