Medical Device Registration in Liberia: LMHRA Guidelines and Requirements

Regulatory Authority

Liberia Medicines & Health Products Regulatory Authority (LMHRA)

The Liberia Medicines & Health Products Regulatory Authority (LMHRA) is the statutory arm of the Government of Liberia with responsibility to ensure that all medicines and health products circulating the borders of Liberia are safe and efficacious. The LMHRA was established based on provisions of the National Drug Policy for the establishment of a Medicines Regulatory Authority to enact and update medicines regulations to regulate the Pharmaceutical Sector, and establishment of a national quality control laboratory under the Authority. The Authority was officially established on 29 September 2010.

Their role is to protect and enhance public and animal health. They do this by assessing the safety, quality and effectiveness of medicines and health products on behalf of the public to ensure the benefits they provide outweigh any potential risks. Their core regulatory functions and their aims and objectives are expressed in their mission, vision and values.

Link for Regulatory Authority 

https://lmhra.gov.lr/

Local Regulation

Medicines & Health Products Regulatory Authority (LMHRA) Act – Regulation on Medical Devices Registration

https://www.lmhra.gov.lr/new/pg_img/REGULATION%20ON%20MEDICAL%20DEVICES.pdf

Classification of Medical Devices

• IVD – Class A, B, C and D

Listing or Registration Requirements

• An application for registration of a medical device shall be submitted to the Authority
  by the applicant or a local agent appointed on its behalf.
• Determine the device classification
• Local Agent submits the Power of Attorney, Official agreement to the agency
• Two commercial sample packs of the product may be requested

Documents Required for Registration

Class A non-exempted medical device

• Copies of the label of the medical device for both primary and secondary components of a medical device system, members of a medical device family, and accessories submitted for registration
• IFU
• The patient information leaflet where applicable
• For sterile medical devices: the sterilization validation report or medical devices with measuring function: certification on medical devices
  metrology or equivalent
• For active medical devices, certification to electrical safety standards
• Any other information as may be required by the Authority

Class B,C and D

• Description and specifications of the medical devices and the materials used in their manufacture and packaging
• A description of the features of the medical devices that permit them to be used for the medical conditions, purposes, and uses for which it is manufactured, sold, or represented;
• A list of the countries other than the country of origin where the device has been sold and a summary of any reported problems with the medical device and any recalls of the medical device in those countries; if applicable.
• A risk assessment comprising analysis and evaluation of the risks, and the risk reduction measures adopted to satisfy the safety and effectiveness requirements as provided in ISO 14971;
• A quality plan setting out the specific quality practices, resources, and sequence of activities relevant to the medical device;
• Manufacturing process of medical devices;
• List of the standards complied with in the design and manufacture of the medical devices to satisfy the safety and performance requirements;
• A detailed summary of information of all studies which the manufacturer relies on to ensure that the medical device meets the safety and performance requirements, including

1. Pre-clinical and clinical studies
2. Process validation studies
3. If appropriate, software validation studies
4. Literature reviews

• In the case of a medical device other than an in vitro diagnostic device, manufactured from or incorporating human tissue or their derivative, objective evidence of the biological safety of the medical devices;
• In the case of a near patient in vitro diagnostic medical devices, detailed information on investigational testing conducted on the device using human participants representative of the intended users and under conditions similar to the conditions of use;
• A bibliography of all published reports dealing with the use, safety, and effectiveness of medical devices;
• A copy of the medical devices label;
• A copy of the quality management system certificate as a stipulation certifying that the quality management system under which the medical device is designed and manufactured satisfies the requirements stipulated in the guideline in force at the time of application

Registration Timeline

• IVD registration (Regular) – 9 months
• IVD registration (Fast-track) – 6 months

Registration Fee

• The applicant shall pay US$300.00 for registration of a medical device
• The applicant shall also pay an annual retention fee US$50.00 

License Validity

3 years

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication? 

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk