Medical Device Regulatory Requirements in Croatia

Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)

Regulatory Authority Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations Law about Medical Products | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations (EU) 2017/746 | Click Here
Device Classification Guidelines Refer to Annex IX for Classification rules | Click Here
Registration Process Procedure for registration | Click Here
Registration Timeline For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product
Conformity Assessment Route

The conformity assessment procedure is highlighted in Annex IV Article 17 highlights  the process of obtaining conformity assessment in Croatia. 

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Requirement of Authorized Representative Yes
Language Requirement Labels must be in Croatian or English Language
Clinical Trials Information

Administrative support for the activities of the Central Ethics Committee is provided by the Agency for Medicinal Products and Medical Devices.

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Database Medical Device Database | Click Here
Fees for Submission

All prices are expressed in EUR, VAT not included.

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Declaration of Conformity

Refer to Annex VIII for DoC
Post Market Surveillance

Medical device safety information

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Adverse Event Reporting Timelines

The manufacturer of a medical device must report adverse incidents to the Agency by the following deadlines:

  1. where there is a serious threat to public health: immediately, but not later than two days from the day the manufacturer became
Advertising and Promotions

Advertising of medical devices is regulated by Articles 59 and 60 of the Medical Devices Act (Official Gazette, no. 76/13).

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Additional Information

The technical documentation and declaration of conformity has to be kept for at least five years after placing the medical product on the market.
Contact Phone +385 1 4884 100
Contact Email halmed@halmed.hr
Contact Address Ksaverska cesta 4 10 000 Zagreb
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 07/Oct/2025

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