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.

For more information on this or any other legal, tax, or business topic, feel free to write to us at [email protected] at any time or call us at phone number +381113281914 every working day from 08:30 to 16:30.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your AK STATT representative, or other competent legal counsel.


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