Register Medical Device in Serbia: A Complete Guide

Medical devices are essential in healthcare, supporting patient care, diagnosis, and treatment. If you want to register a medical device in Serbia, understanding the process is critical. The Medical Devices Law and related regulations govern this process. This guide will help you navigate the steps for registration, sale, and importation of medical devices in Serbia.

Why Is Registering a Medical Device in Serbia Important?

In Serbia, registering medical devices ensures compliance with safety and regulatory standards. It helps protect patients and provides safe, effective products. The Medicines and Medical Devices Agency of Serbia (ALIMS) is responsible for overseeing the registration and regulation of medical devices. ALIMS ensures all medical devices entering the market meet safety standards.

The Registration Process for Medical Devices in Serbia

The registration process in Serbia is divided into two main categories:

  1. National Registration: For devices not yet registered in any EU Member State or those not on the market.
  2. EU Mutual Recognition: For devices already registered in an EU Member State, intended for sale in Serbia.

National registration applies to devices that haven’t entered the EU market yet. EU mutual recognition makes the process easier for devices already approved in the EU.

Step-by-Step Guide to Registering a Medical Device in Serbia

The process of registering a medical device in Serbia involves multiple steps. Below, we outline the steps for both national registration and EU mutual recognition procedures.

National Registration Process

Follow these steps to register a medical device in Serbia nationally:

  1. Applicant Registration
    The applicant, either the manufacturer or an authorized representative, must first register with ALIMS. The applicant submits an application form, proof of identity, business registration documents, and authorization letters.

  2. Prepare Technical Documentation
    The applicant must prepare technical documentation for the device. This includes its design, intended use, performance characteristics, clinical evaluations, labeling, and instructions for use. This step is vital to demonstrate the device’s compliance with safety standards.

  3. Conformity Assessment
    The device must undergo a conformity assessment. This assessment checks whether the device meets the required standards. It may include type examinations, design assessments, or clinical evaluations, depending on the device’s complexity.

  4. Submit the Application
    After completing technical documentation and conformity assessments, submit the application to ALIMS. This submission must include a summary of technical documentation, a statement of compliance, and other required documents.

  5. Review and Decision
    ALIMS reviews the submitted application to ensure compliance with Serbian regulations. This review may involve inspections or laboratory testing. If approved, ALIMS issues a registration certificate. The certificate is valid for five years and can be renewed.

EU Mutual Recognition Process

If your medical device is already registered in an EU Member State, you can follow these steps to register it in Serbia:

  1. Declaration of Conformity
    The manufacturer or authorized representative must issue a declaration of conformity. This document confirms that the device meets EU regulatory requirements.

  2. Submit the Application
    Submit the declaration of conformity along with other supporting documents to ALIMS.

  3. Review and Decision
    ALIMS will review the submitted documents. If everything is in order, ALIMS issues a license for the device. The license is valid for five years.

Selling and Importing Medical Devices in Serbia

Once your device is registered or licensed in Serbia, you can sell and market it to healthcare institutions and patients. However, there are specific guidelines to follow.

Sale of Medical Devices

The Law on Advertising of Medicines and Medical Devices regulates advertising medical devices in Serbia. Ads must be:

  • Factual, accurate, and non-misleading.
  • Targeted at medical professionals and healthcare institutions only.
  • Prohibited from suggesting that a device can treat conditions for which it is not authorized.

Medical devices sold in Serbia must be labeled in Serbian. The label should include the manufacturer’s name and address, the device’s intended use, and storage or handling instructions. The instructions for use must also be in Serbian.

Importing Medical Devices

If you plan to import medical devices into Serbia, follow the same steps as registration and sale. Importers must secure a license or registration certificate from ALIMS before importing devices. Additionally, importers must comply with customs regulations, including duties and taxes. It is essential to meet all customs requirements and obtain necessary permits.

Conclusion: Key Takeaways for Registering a Medical Device in Serbia

Successfully registering a medical device in Serbia requires attention to regulatory procedures. By following the Medical Devices Law and related regulations, manufacturers, importers, and authorized representatives ensure their devices are safe and effective for patients.

Here are the key steps to register a medical device in Serbia:

  • Register the applicant with ALIMS.
  • Prepare and submit technical documentation.
  • Complete a conformity assessment.
  • Submit the application for review.
  • Receive the registration certificate or license.

If you’re considering entering the Serbian market, it’s important to understand the registration process and meet the regulatory requirements. ALIMS oversees the process and ensures compliance. Therefore, working closely with ALIMS ensures a smooth registration experience.

By following these steps, you help improve healthcare in Serbia and ensure access to safe, high-quality medical devices for patients.


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

Disclaimer: The information in this guide is for educational purposes only. This resource is not designed to be, and should not be used as, the sole source of information when analyzing and resolving legal issues. It should not replace legal advice, which depends on specific factual analysis. Additionally, laws in each jurisdiction differ and evolve. This information is not intended to create an attorney-client relationship. For specific advice regarding a situation, consult your AK STATT representative or other competent legal counsel.

ALIMS, ALIMS registration process, EU mutual recognition Serbia, EU regulations Serbia, healthcare regulations Serbia, medical device advertising Serbia, medical device approval Serbia, medical device conformity assessment, medical device declaration of conformity, medical device guidelines Serbia, medical device import license, medical device importation Serbia, medical device industry Serbia, medical device labeling Serbia, medical device laws Serbia, medical device licensing, medical device market Serbia, medical device registration process, medical device registration Serbia, medical device safety Serbia, medical device sale Serbia, medical device technical documentation, medical devices in Serbia, national registration medical device, register medical device in Serbia, registration of medical devices, registration of medical devices Serbia, Serbia healthcare regulations, Serbia medical device laws, Serbia medical devices, Serbia medical laws, Serbian healthcare market, Serbian import regulations, Serbian medical device agency, Serbian medical device import, Serbian medical device market, Serbian regulatory requirements

    Ready to Achieve Your Goals? Contact us Today.

    Fill out our quick contact form below. Shortly thereafter we’ll let you know how to proceed. It’s that simple.

    By submitting your contact information, you agree that we may contact you by telephone (including text) and email in accordance with our Terms and Privacy Policy.

    Call Message