W.H.O PLEDGES SUPPORTS AND COLLABORATION WITH MLSCN IN REGULATION AND EXPANSION OF QUALITY ASSURED IVD MANUFACTURING IN NIGERIA AND THE WEST AFRICAN SUB- REGION.
W.H.O PLEDGES SUPPORTS AND COLLABORATION WITH MLSCN IN REGULATION AND EXPANSION OF QUALITY ASSURED IVD MANUFACTURING IN NIGERIA AND THE WEST AFRICAN SUB- REGION.
The World Health Organisation (WHO) Laboratory Team Led by Dr Laxmikant Chavan has given the assurance of the WHO Nigeria’s support for the Medical Laboratory Science Council of Nigeria (MLSCN) Public Health In-Vitro Diagnostics Control Laboratory to ensure qualitative regulation of In- Vitro Diagnostics (IVDs) for Laboratory testing through the conduct of on-site Medical Device Quality Management System (MDQMS) and risk assessments as well as mentorship of local manufacturers to produce IVDs that meet international standards in addition to the continuous efforts of the MLSCN-IVD Laboratory in verification, evaluation and post market validations exercises in order to promote effective regulation and production of locally made IVDs that aligned with the unlocking the value chain initiative of the Federal Government with the act establishing the laboratory.
He made the call during the capacity building workshop for MLSCN National IVD Laboratory Staff supported by World Health Organization (W.H.O) and facilitated by Standard Organization of Nigeria (SON) and Global Medical Devices Nomenclature (GMDN), United Kingdom at the MLSCN ISO 17025:2017 Accredited IVD Laboratory training center, Yaba, Lagos from 28th October to 1st of November 2024.
The theme of the workshop was “Unlocking the value chain of In-vitro Diagnostic (IVD) Manufacturing in Nigeria: Strengthening Regulatory capacity through ISO certifications”
In his own submission, Mr. Jubril Kareem the Laboratory Technical Officer added that the WHO position on the ISO 13485 and 14971 certifications for the IVD laboratory staff is to support the strengthening of IVD laboratory capacity to meet international standards as National IVD regulator and to possess requisite qualifications to support training and sensitization of local IVD manufacturers to produce quality assured IVDs for Laboratory testing.
Furthermore, he believes through the ISO 17025:2017 accredited Public Health In-vitro Diagnostic Control Laboratory, Yaba, Lagos centre, an internationally accredited center rendering world class services in validation, verification and evaluation processes of all in-vitro diagnostic products imported into the country or produced in Nigeria, MLSCN should not only regulate but mentor the local manufacturers to improve the quality of their productions to meet both local and international standard.
The Registrar, Prof. Tosan Erhabor called for the inclusion of MLSCN in Nigerian Trade Portal, Export / Import Guideline in line with extant laws of Nigeria (Act 11, 2003, Sub-section 4d and 4e) and that there should be a stop to the harassment of clients with MLSCN Import permit and seizure of IVD products. He called on the general public to demand for MLSCN LISTING NUMBER ON ALL IVD PRODUCTS IN NIGERIA.
Prof. Tosan Erhabor, reiterated that to support the IVD regulation and expansion of quality assured IVD manufacturing in the West African sub-region, MLSCN conducted this capacity building workshop to strengthen the national IVD Manufacturing Assessors especially with the knowledge on IVD products global harmonized nomenclature, ISO 14971:2019- RISK MANAGEMENT and ISO 13485:2016 FOR QUALITY MANAGEMENT SYSTEM FOR IN VITRO DIAGNOSTICS MANUFACTURERS. This is in sync with the vision of the current administration of the Federal Ministry of Health to utilize locally manufactured in vitro diagnostic products in the testing programmes of diseases of public health impact like HIV/AIDS, malaria and tuberculosis, etc. MLSCN regulatory capacity is positioned to assess, certify, and support local IVD manufacturers via assessment and follow-up mentorship to attain ISO 13485 and ISO 14971 quality management system and risk assessment requirements in Nigeria respectively. This is expedient to expedite access to critical procurement pathways for diagnostic products in Nigeria, he concluded.
The Laboratory Manager to MLSCN PUBLIC HEALTH IN-VITRO DIAGNOSTICS CONTROL LABORATORY and Head of IVD Department, Mr. Offutalu Paulinus Nnamdi, in his speech enumerated some of the outcomes of the training to include: Reviewed assessment checklists and protocols for assessment and certification of the six registered IVD Manufacturing facilities awaiting audit and certification and the 50 IVD importers in Nigeria. He noted that, of the over 250 Listed IVD products in Nigeria, over 98% are imported. Thus, there was an urgent need to build the IVD manufacturing capacity for Nigeria. This will no doubt reduce over dependence on imported IVD products and provide access to affordable IVD products in Nigeria.
The facilitators from Standard Organisation of Nigeria (SON) and Global Medical Device Nomenclature (GMDN), UK, emphasized the need for RISK MANAGEMENT below residual risk levels and harmonized standard nomenclature for IVD products.
The training had in attendance the facilitators from the Standard Organization of Nigeria (S.O.N), Mr Victor Odiaua and Mrs Oludunke Oluwafunmilayo, Dr Francisca Nwaokorie, an associate Professor from University of Lagos, Adekoya Abimbola Julius, Chairman GMLD Lagos, Mr Oparanozie Jude, Chief Medical Laboratory Scientist and the Quality Assurance Manager of the IVD Laboratory and other members of staff of the IVD Laboratory.