Medical Device Registration Liberia
Ministry of Health
Regulatory Authority
Liberia Medicines & Health Products Regulatory Authority (LMHRA)
Official Language
English
Classification
IVD – Class A, B, C & D
Medical Device Registration in Liberia
- 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
- 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