Medical devices and medical equipment are not subject to registration in Mongolia. An import license shall be obtained to carry out the import.
Medical devices for diagnostics (diagnostic kits) are subject to registration according to Order of the Ministry of Health of Mongolia No. 13 dated January 15, 2015 “On approval of the provision on registration of medicinal products and substances.”
The dossier shall be prepared and submitted for registration according to national specific requirements. The format of the dossier is national.
The procedure for registration of medical devices for diagnostics is similar to the procedure for registration of medicinal products.
Cratia provides professional services of state registration of medical devices in Mongolia. We have an excellent knowledge of national legislation, necessary experience and resources.