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

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