MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
HIGHLIGHTS
Keep up to date!

News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

RMD 2017 Europe
06-07 October, 2017
Berlin, Germany


9. Medical Device Networking Meeting - 
a RAPS Roadshow
November 30, 2017
Hannover, Germany

more...



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Starting July 1, 2013, Croatia is an official member of the European Union

Many laws and regulations on medical devices have already been adjusted to the European requirements. The responsible entity for the registration of medical devices in Croatia id the Agency for Drugs and Medical Devices in Croatia (HALMED). The contact address can be found at www.halmed.hr (Croatian/English).

The most important facts:

  • Medical devices (except risk class I ) and in vitro diagnostic devices must be registered in Croatia by the manufacturer or the distributor
  • Information made available to the user (instructions for use, labels) must be in Croatian language

Medical Device Act (New): http://narodne-novine.nn.hr/clanci/sluzbeni/2013_06_76_1521.html (Croatian only)

Medical Device Act (obsolete): http://www.halmed.hr/upl/zakoni/zakoni_30_en.pdf

Ordinance on Essential Requirements, Classification, Quality System, Entry into the Register of Manufacturers and Register of Medical Devices and Assessment of Conformity of Medical Devices: http://www.halmed.hr/upl/zakoni/zakoni_42_en.pdf