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Latvia

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Latvia

Medical Device Registration in Latvia

Ministry of Health

Cabinet of Ministers Republic of Latvia

Regulatory Authority

State Agency of Medicines , Republic of Latvia

Medical Device Regulation

Medical Treatment Law

Regulation No. 689 – Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices

EU MDR 2017/745

Official Language

Latvian

Classification

Class I, IIa, IIb and III

Registration Process

  • Determine the device classification
  • Appoint Authorized Representative and Notified Body
  • Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
  • For other classes, prepare a CE Technical File
  • Obtain and register UDI in EUDAMED.
  • Technical File should be audited by Notified Body.
  • Once approved, prepare a Declaration of Conformity.
  • The device can now be marketed in Latvia

Documents Required

  • CE Certificate
  • Declaration of Conformity
  • Technical File
  • QMS Certificate
  • Risk Management Plan
  • IFUs, Label or User Manual
  • Clinical Studies Report
  • Postmarket Surveillance Plan

Applicable QMS

ISO 13485

Registration Timeline

Class I: 4-6 weeks

Other: Based on Notified Body

Authorized Representative

Yes

License Validity

5 years

Special Notes

  • IFUs and Labels should be in the Latvian language
  • The notification of class I, and other IVD medical devices is not mandatory.
  • There are no fees for notification and registering medical devices at the national medical devices database.

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