Ministry of Health

Ministry of Health of the Republic of Serbia

Regulatory Authority

Medicines and Medical Devices Agency of Serbia(ALIMS)

Medical Device Regulation

Law on Medicines and Medical Devices of Serbia

Official Language

Serbian

Classification

Class I, IIa, IIb, III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative
• Prepare application form and registration dossier
• Submit product samples for testing
• Submission will be reviewed by the Competent Authority
• Once approves, the registration certificate will be issued
• The product can now be marketed in Serbia

Documents Required

• Application Form
• Technical Documentation or Registration Dossier
• User manuals, IFUs, Labelling
• Other regulatory approvals
• Insurance policies of the product
• Postmarket vigilance plans

Applicable QMS

ISO 13485

Registration Timeline

82 working days

Authorized Representative

Yes

License Validity

5 year

Special Notes

Medical devices must be labelled in the Serbian language