Medical Device Regulations in Croatia

Regulatory Agency

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) regulates the medical devices in Croatia

Medical Device Definition

Medical Device: A medical device is any instrument, device, appliance, software, material or other object used alone or in combination with another object, including software, intended by its manufacturer for diagnostic or therapeutic purposes and which software is necessary for its proper use, intended by the manufacturer for use in humans for:

Diagnosing, preventing, monitoring, treating and alleviating disease
Diagnosing, monitoring, treating, controlling, alleviating or eliminating a physical impairment or defect
Testing, eliminating or replacing or modifying the anatomical or physiological functions of the organism
Birth control

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic effects, although its action may be assisted by such effects.

Active Medical Devices: medical devices that rely for their use on an electrical power source or on a source of energy other than that directly produced by the human body or gravity.

Active Implantable Medical Devices: active medical devices intended to be fully or partially implanted into the human body by surgical or medical procedure or to be implanted into a natural body orifice by medical procedure and to remain there after such procedure.

Accessories – An accessory is a product that is not a medical device, but is expressly intended by the manufacturer for use with a medical device, thus enabling the use of the medical device in accordance with its intended purpose as determined by the manufacturer.

Medical Device Classification System

Classification	Risk Level	Examples
l Is (sterile) Im (measuring) Ir (reusable)	Low Risk	Wheelchairs, Stethoscopes, Spectacles
IIa	Medium Risk	Dental fillings, Surgical clamps, Tracheotomy tubes
IIb	Medium High Risk	Lung ventilators, Bone fixation plate, Condoms
III	High Risk	Pacemakers, Heart valves, Implanted cerebral simulators

Regulatory Approval Process

Classification	Approval Procedure
I	The procedure for registering a medical device in the register of medical devices is initiated by a written request submitted to the Agency in the Croatian language no later than 15 days from the date of placing the medical device on the market. Applications for registration of medical devices of risk classes Is and Im are submitted separately, and products covered by the same certificate of conformity may be grouped in a single application. The Agency shall, within 60 days from the date of receipt of a complete application, issue a decision granting or denying the entry of the medical device in the register of medical devices.
IIa IIb III	Notifications of placing a medical device on the market are submitted by legal and natural persons who place on the market Class IIa, IIb and III medical devices Notifications of placing a medical device on the market are sent to the Agency in writing, not later than 15 days from the day of placing the medical device on the market. Notification of placing the medical devices on the Croatian market should be sent directly to HALMED via medpro@halmed.hr e-mail address, or through a local distributor. The notification e-mail should have the following title: Notification about placing on the market_name of manufacturer_name of product or product group and must have the following documents. If the Agency determines that the application is not in order, it shall request the applicant to eliminate the aforementioned deficiencies and submit the requested data and documents within a period not exceeding 30 days from the date of receipt of the conclusion. If the applicant fails to remedy the deficiencies or submit the requested data and documents, the Agency shall refuse registration; no appeal is permitted, but an administrative dispute may be initiated.

Classification

Approval Procedure

The procedure for registering a medical device in the register of medical devices is initiated by a written request submitted to the Agency in the Croatian language no later than 15 days from the date of placing the medical device on the market.
Applications for registration of medical devices of risk classes Is and Im are submitted separately, and products covered by the same certificate of conformity may be grouped in a single application.
The Agency shall, within 60 days from the date of receipt of a complete application, issue a decision granting or denying the entry of the medical device in the register of medical devices.

IIa
IIb
III

Notifications of placing a medical device on the market are submitted by legal and natural persons who place on the market Class IIa, IIb and III medical devices
Notifications of placing a medical device on the market are sent to the Agency in writing, not later than 15 days from the day of placing the medical device on the market.
Notification of placing the medical devices on the Croatian market should be sent directly to HALMED via medpro@halmed.hr e-mail address, or through a local distributor.
The notification e-mail should have the following title: Notification about placing on the market_name of manufacturer_name of product or product group and must have the following documents.
If the Agency determines that the application is not in order, it shall request the applicant to eliminate the aforementioned deficiencies and submit the requested data and documents within a period not exceeding 30 days from the date of receipt of the conclusion.
If the applicant fails to remedy the deficiencies or submit the requested data and documents, the Agency shall refuse registration; no appeal is permitted, but an administrative dispute may be initiated.

Additional Information

Approval Timeline	Not specified by the agency
License validity period	5 years
Fees	From 700 € to 1000 €

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