Medical devices notification in Slovakia becames very popular but the procedure itself is not as easy as many clients think. In Slovakia we have of course national specifications which we needs to follow. The first important step is to have registered importer or registered distributor responsible for Medical Devices.
What does it mean to have registered importer/distributor?
The registered importer or distributor is approved and notified to State authority for Drug Control (SÚKL) and is visible on SÚKL webiste. Registered distributor is legal entity in Slovakia and needs to have stated in their Power of Establishment that he is obliged to distribute MD in Slovakia and fulfill other requirements according to the Act. No 362/2011 about medicines and medical devices.
Notification of distributor costs 500€ to SÚKL.
Once distributor is approved, Medical Devices could be notified. Distributor has 14 days to notify medical devices after launch of MD into the Slovakian market.
Notification of Medical Devices to SÚKL?
Notification includes (SÚKL´s Forms in SK language, SÚKL´s Cover letter, SÚKL´s proposal for invoice, SÚKL´s Power of Attorney, IFU – instruction for use in SK language, label in SK language, Declaration of Conformity (DoC), EC certificate, catalogue number and other information depending on MD class). Notification could be done in paper form or in electronical form.
Approval of notification (up to 3 months) is not offically issued but medical device is visible on SÚKL website in Medical devices register once approved.
NJ Pharma has very experienced experts in Medical devices field who are regularly trained.
