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Liberia

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Liberia

Medical Device Registration Liberia

Ministry of Health

Ministry of Health

Regulatory Authority

Liberia Medicines & Health Products Regulatory Authority (LMHRA)

Official Language

English

Classification

IVD – Class A, B, C & D

Registration Process

  • Appoint an Authorized Representative in Liberia
  • Determine the device classification
  • Authorized Representative submits the Power of Attorney, Official agreement to the agency
  • Two commercial sample packs of the product may be requested

Documents Required

  1. The application form.
    ii. Details of the IVD.
    iii. Technical documents summary
    iv. Labeling information as per the Guideline for Labeling and Packaging
    v. Checklist for Crucial requirements
    – Risk Management Plan
    – Design & Manufacturing Information
    – Specifications
    – Analytical performance
    – Stability
    – Clinical performance

Applicable QMS

ISO 13485

Registration Timeline

Regular processing – 9 months

Fast track processing – 6 months

Authorized Representative

Yes

License Validity

5 years

Want to know more about this registration process?

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