Ministry of Health
Ministry of Health
Regulatory Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
Medical Device Regulation
EU MDR 2017/745
Medical Devices Act (No. 98/09)
Official Language
Slovene
Classification
Class I, IIa, IIb and III
Registration Process
Documents Required
Post-market Requirements
Applicable QMS
ISO 13485
Registration Timeline
Class I – 4-6 weeks
Others – Depending on the timeline by Notified Body
Authorized Representative
Yes
License Validity
5 years
Special Notes
IFUs or Labels should be in Slovenian or English
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.