H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

General information about EMKI’s certificating activity

EMKI performs certificating of quality systems according to ISO 9001 and ISO 13485 standards and conformity assessment of medical devices / IVD devices.

EMKI’s statement about its quality policy is available here.

EMKI proceeds during its activity according to the document attached: Procedure for Conformity assessment procedure.

For details please see concerning pages:

           Certificating quality systems

           Conformity assessment and certification of medical devices

           Conformity assessment and certification of IVD devices


Form used for order and request for quotation can be found among documents to download.

Procedure regarding appeal or complaint against certification decision can be found here: Procedure of appeal and complaint handling.

Form needed for initiating process can be found among documents to download.

With the first edition of the certificate, clients get informing about application rules of certification symbols. For quality systems and devices, certified by EMKI, procedure how to refer to being certified and usage of certification symbols is available here: Use of certification symbols.

Last updated: 2018.04.18 12:55