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Liechtenstein

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Liechtenstein

Medical Device Registration Liechtenstein

Ministry of Health

The Ministry of Public Health

Regulatory Authority

Amt fur Gesundheit

Medical Device Regulation

EU MDR 2017/745

Official Language

German

Classification

Class I, IIa, IIb, III and IV

Registration Process

  • Determine the classification of the device
  • Implement QMS in accordance with ISO 13485
  • Appoint Authorized Representative and Notified Body
  • Medical devices must be CE marked.
  • Prepare and submit the Technical File
  • Register with competent authorities
  • Once approved, manufacturer may market the medical device.

Documents Required

  • Manufacturer business registration
  • QMS ISO 13485 certificate
  • CE certificate
  • EC Declaration of Conformity (DoC)
  • IFU in Bulgarian
  • Risk Management File as per ISO 14971
  • Clinical Evaluation
  • Post-market surveillance
  • Biocompatibility as per ISO 10993
  • Product manufacturing flowchart
  • Test reports
  • Technical File

Post-market Requirements

Serious public health threats – 2 day

Death or serious health deterioration – 10 days

Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I – 6 weeks

Other depends on the type of the product.

Authorized Representative

Yes

License Validity

5 years

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