Liberia Medicines & Health Products Regulatory Authority Begins Regulation of Medical Devices, In-vitro -diagnosis diagnostics (IVD)
MONROVIA – The Liberia Medicines & Health Products Regulatory Authority (LMHRA) has initiated the full listing of all medical devices including in vitro diagnostics that are imported into the country, their manufacturers and the pharmacies that are importing those products.
This process will be followed by full compendium testing at the Quality Control Laboratory at the LMHRA.
Poor-quality medical devices including in vitro diagnostics (Hepatitis or HIV tests, Pregnancy tests, Blood- sugar monitoring systems for diabetics, etc.) and In-vitro-diagnosis (samples such as blood or tissue that have been taken from the human body) are as dangerous as substandard and falsified medicines.
From this backdrop, the LMHRA, the government arm clothed with the responsibility to ensure that all medicines and health products are safe, effective and of good quality has begun the process of quality assurances of for all medical devices imported into the country.
Medical devices including in vitro diagnostics play a major role in prevention, diagnosis and treatment of diseases, so much that if they are needs to be done to ensure that they are not of good quality, otherwise, it may lead to wrong diagnosis, treatment failures and even death.
The Improved Governance and Research Capacities in Diagnostics for Infectious Diseases (IGORCADIA) Project with fund from the European and Developing Countries Clinical Trial Partnership (EDCTP) which was initiated in 2017, the LMHRA begun building the capacity of its technical staff in the regulations of these products.
A regulatory framework form of a guideline for market authorization of medical devices including in vitro diagnostics have been developed and for in vitro diagnostics (IVDs) have been developed validated.
Guidelines for marketing authorization of medical devices including in vitro diagnostics have also been developed and finalized, moreover, three staff at the LMHRA, all members of the IGORCADIA Technical Working Group (TEGTWG) have benefited from external training in the regulations of IVDs (IVD Dossier evaluation, Registration of IVDs, Inspection & Post-market Surveillance of IVDs and Quality Control of IVDs) in Accra, Ghana.
However, several members of the staff of both LMHRA and St. Joseph’s Catholic Hospital have also been trained and certificated in various aspects of diagnostics and diagnostics research including research methodologies (both qualitative and quantitative), ethics in research, etc.
Based on the participation of the Project Coordinator, Mr. Alexander E. George at the 4th Biennial Scientific Conference for Medical Product Regulations in Africa and the 6th African Medicines Regulators’ Conference in Victoria Falls, Zimbabwe, Liberia is now a member of the African Medical Device Forum (AMDF).
The Managing Director of the LMHRA, Madam Keturah C. Smith have stressed the need for all medical products imported into the country to be quality assured in order to boost public confidence in the usage of these products.
Pharmacist Smith made the disclosure at the regular technical staff meeting last week at which time she pointed out that poor quality Blood Pressure cuff (BP- Cuff) machine will lead to wrong blood pressure reading which could lead to wrong diagnosis and wrong treatment or therapeutic failures and death.
She disclosed that the LMHRA has obtained International Standard Organization (ISO) 2009 and 2015 certification.
She added that the LMHRA ISO certification indicated that the institution has met the Quality Management System (QMS) standards, which means that the LMHRA have demonstrated the ability to consistently provide services that meet customer and regulatory requirements and is working to enhance customer satisfaction through the effective application of the system.
“With the wave of substandard and falsified medicinal products circulating in the sub-region, we can now be assured that as the IGORCADIA project comes to an end on November 30, 2019, we as a nation must work hard to sustain the gains made through this IGORCADIA project,” she added.
“We are calling on our international partners to support the LMHRA to expand its quality control laboratory to enable us conduct a wide range of laboratory analysis analyses for all drugs medical and health products to ensure that all the medicines and health medical products within the country are safe effective and of good quality,” MD Smith concluded.