Croatia Medical Device Registration Requirements

M

MD_Simy86

#1
Dear all,
I’m looking for some information regarding new medical devices registration in order to commercialize in Croatia:
- Is it necessary to have obtained the CE marking for the product?
- Can you kindly address me to the regulation for medical devices?
- Are there any fees to be paid?

Thank you in advance for the availability and support,
Best regards,
 
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rangani_rj

Involved In Discussions
#2
Hi Simy_86

All info regarding regulation of Medical device is give on HALMED, a regulatory agency of Croatia.

Laws pertaining to MD
1. Medical device act –general provision (Official Gazette, No. 76/13)
2. ON ESSENTIAL REQUIREMENTS, CLASSIFICATION, REGISTRATION OF MANUFACTURERS IN THE REGISTER OF MEDICAL DEVICE MANUFACTURERS, REGISTRATION OF MEDICAL DEVICES IN THE REGISTER OF MEDICAL DEVICES AND CONFORMITY ASSESSMENT OF MEDICAL DEVICES (Official Gazette, No. 84/13)

Regulation is similar to EU directive. It is exact photocopy.

Classification is similar to EU. Medical device - I, IIa , IIb, III and IVD - list A, list B, self-testing and other.

CE marking is compulsory.

Entry of device in register/databank is compulsory and chargeable.

Fee structure for all types of activity (new registration, wholesale selling, retail sell) is given on website – look at Fee section.

Have a Nice day.......
 
M

MD_Simy86

#3
Hi rangani_rj:bigwave:,
thank you so much for the information provided here below!!

Have a nice day,
see you:applause:
 
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