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