Croatia Medical Device Registration

Navigating Regulatory Affairs in Croatia: HALMED Guidelines for Medical Devices

Overview

As of July 1, 2013, Croatia officially became a member of the European Union (EU), and the oversight of regulatory and compliance activities for medicinal products and medical devices in the region is managed by the Agency for Drugs and Medical Devices (HALMED). While efforts have been made to align Croatia’s registration requirements with EU Directives, complete alignment has not yet been achieved. This may pose challenges for newcomers in terms of regulatory planning.

Freyr, a specialized global regulatory services provider, offers comprehensive consulting services for Regulatory affairs in Croatia. With expertise in serving as a professional European Authorized Representative, Freyr can navigate and facilitate the registration procedures for medicinal products and medical devices for foreign/non-EU manufacturers in Croatia.

Regulatory Authority

Agency for Medicinal Products and Medical Devices (HALMED)

The Agency for Medicinal Products and Medical Devices is a legal entity vested with public authority. It was established on 1st October 2003 as a legal successor to the Croatian Institute of Medicines Control and the Croatian Institute of Immunobiological Preparations Control, albeit with a considerably broader scope of work.

The Agency was established by the Republic of Croatia. Legal compliance of the Agency is supervised by the Ministry of Health.

It generates its own income through service fees and annual charges for provision of services from its scope of work, as well as through other sources in accordance with the Medicinal Products Act and other regulations.

The Agency provides services pertaining to medicinal products, medical devices, homeopathic medicinal products and veterinary medicinal products in accordance with the primary and secondary legislation of the Republic of Croatia.   

Link for Regulatory Authority

https://www.halmed.hr/en/Medicinski-proizvodi/Upute-za-podnositelje-zahtjeva-41/

Local Regulation

• Law on Medical Devices, NO. 71-05-03 (18 Jun. 2013)
• Ordinance on the essential requirements, classification, registration of producers in the register, the registration of medical devices in the register of medical devices, and conformity assessment of medical devices (Official Gazette, 84/13)
• Ordinance on monitoring adverse events related to medical devices (Official Gazette NO. 125/13)
• Ordinance on good practice in wholesale distribution of medicinal products and the conditions for the entry in the register of wholesalers of medical devices (Official Gazette NO. 83/13)
• MDR (EU) 2017/745

Classification of Medical Devices

Class I, II, IIa, IIb and III

Listing or Registration Requirements

• Medical device manufacturers in Croatia, including natural and legal persons, and third-country manufacturers .i.e, Authorised Representative are registered in the register of medical device manufacturers.
• The registration process for medical device manufacturers and medical devices requires a written application in Croatian language submitted within 15 days of starting activities.
• Class I medical devices are registered in the register of medical devices. Custom-made devices are not registered in the register of medical devices

Documents Required for Registration

• The manufacturer’s declaration of compliance with the essential requirements,
  • Explanation of the classification of the medical device,
  • Certificate of conformity of the notified body for sterile products and products with measuring function,
  • Marking and instructions for use in the Croatian language, and in the case of a product of a foreign manufacturer, and the original marking and instructions for use in the English language, if applicable,
  • A general description of the product, including any planned variations and purpose of the product,
  • The results of the risk analysis and the list of standards, applied in full or in part, and descriptions of the solutions accepted to meet the essential requirements of this Ordinance if the standards are not fully accepted
  • A clinical evaluation in accordance with Annex X to this Ordinance, which forms an integral part thereof
  • List of medical devices covered by the application in electronic form
  • Proof of paid costs of the procedure
  • Confirmation of paid administrative fee.
• The documentation shall be attached in a copy, and the Agency may request the original from the applicant for inspection.

Registration Timeline

• Class I devices: Typically, 2-3 months.
• Class IIa, IIb, and III devices: 1-9 months, with more complex devices taking longer.

Registration Fees

There is a general registration fee of HRK 225 for accessing the register of medical devices, regardless of the device class.

License Validity

5 Years

Special Labelling Requirements

Labeling must be in Croatian language

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]