Medical Device Registration in
Slovakia
Ministry of Health
Public Health Authority of the Slovak Republic
Regulatory Authority
State Institute for Drug Control (ŠÚKL), Medical Devices Section
Medical Device Regulation
Act No. 362/2011 on medicines and medical devices
Official Language
Slovak
Classification
Class I, IIa, IIb and III
Registration Process
- Determine the device classification
- Appoint an Authorized Representative
- Prepare Registration Dossier and submit to the competent authority
- Once approved, the medical device can be marketed in Slovakia
Documents Required
- Application Form
- Registration Dossier
- Cover Letter
- Letter of Authorization
- Declaration of Conformity
- CE certificate
- Payment Receipt
- QMS certificate
Applicable QMS
ISO 13485
Registration Timeline
4-8 weeks
Authorized Representative
Yes
License Validity
5 years