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WORLD HEALTH ORGANIZATION (W.H.O.) BOOSTS THE REGULATORY CAPACITY OF THE MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)

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WORLD HEALTH ORGANIZATION (W.H.O.) BOOSTS THE REGULATORY CAPACITY OF THE MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)

The World Health Organization (W.H.O) is bolstering Nigeria’s diagnostic capabilities through its support for the Medical Laboratory Science Council of Nigeria (MLSCN). This partnership enhances the MLSCN’s Public Health In-Vitro Diagnostics Control Laboratory, ensuring medical laboratories provide accurate results using quality and validated In-Vitro Diagnostics (IVDs).

These efforts will promote local production of quality IVDs, contributing to the achievement of Sustainable Development Goal 9 (SDG 9) – “Build resilient infrastructure, promote sustainable industrialization and foster innovation.” Additionally, it supports the achievement of SDG 3 (Good health and Well-being) and contributes to Universal Health Coverage (UHC).

This  was the focus of 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) at the MLSCN ISO 17025:2017 Accredited IVD Laboratory training center, Yaba, Lagos from 9th December to 14th  of December, 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 of W.H.O, added that by supporting local IVD manufacturing and importation, the W.H.O is increasing access to affordable and quality diagnostic tools in Nigeria, a critical step towards improving health outcomes and achieving the Sustainable Development Goals.

To him, the collaboration between MLSCN and the Standard Organization of Nigeria (SON), facilitated by the W.H.O, is vital for improving disease diagnosis, treatment, and prevention in Nigeria. This partnership has led to capacity-building and training for MLSCN National IVD Laboratory staff, enabling them to achieve certifications on ISO 13485:2016 (Quality Management System in Medical Devices) and ISO 14971:2019 (Risk Management).

This  training was based on the ISO 13485:2016, Medical Device- Quality Management Systems-Requirements for regulatory Purposes.

The training, which includes Quality Management Systems, management responsibility, resource management, product realization, measurement, analysis, and improvement, will assist the MLSCN National IVD Laboratory staff to perform the audit roles in their regulatory mandate.

In his speech, Mr Offutalu, Paulinus Nnamdi, the Head of the Department of National IVD Laboratory, and who represented the Registrar/CEO of the Medical Laboratory Science Council of Nigeria (MLSCN), Prof. Tosan Erhabor, appreciated the support from W.H.O which according to him will go a long way to enhance the performance of Council in delivering the mandate to regulate the Production, Importation, Sales and Stocking of Diagnostic Reagents, Equipment and Chemicals. This will increase access to affordable and quality in-vitro diagnostic products in Nigeria and West African sub-region.

The team from Standard Organization of Nigeria (SON) was led by Engr. Shehu Ibrahim Malik, PhD, fsi, the Director, SON Training Services. He was glad that SON was able to facilitate the training through the support of the W.H.O. He went further to emphasize that the training has conferred on the trained staff the statue of the  certified ISO 13485:2016 auditors

The week-long training was intensive with gigantic lectures, case studies, application of the lectures through scenarios, and eventual generation of the assessment checklists.

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 Guild of Medical Laboratory Directors (GMLD) Lagos, Mr Oparanozie Jude, Chief Medical Laboratory Scientist and the Quality Assurance Manager of the IVD Laboratory.

Others are Mr Julius Kwata, Mr Bello Mukthar, Mr Simon Bukar, Ms Okunola Precious, and Mr Titus Njing, amongst others. GMDN team joined virtually from London to present on Global nomenclature for in vitro medical devices.

 

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