MLSCN PRESENTS NATIONAL IVD VALIDATION CERTIFICATE TO COLEXA BIOSENSOR LTD AND LISTED THE FIRST INDEGENOUS GLUCOSE MONITORING SYSTEM

 2,554 total views,  2 views today

MLSCN PRESENTS NATIONAL IVD VALIDATION CERTIFICATE TO COLEXA BIOSENSOR LTD AND LISTED THE FIRST INDEGENOUS GLUCOSE MONITORING SYSTEM

The Medical Laboratory Science Council of Nigeria (MLSCN) presented National IVD Validation Certificate to Colexa Biosensor Limited, a subsidiary of Codix Pharma Limited on the occasion of the commissioning of Colexa Biosensor’s groundbreaking ceremony of the In-vitro Diagnostics (IVD) factory—the first of its kind in sub-Saharan Africa and the launch of the revolutionary OnPoint Blood Glucose Monitoring System on the 19th December 2023 at Illupeju, Lagos State.


In a speech of the Registrar of MLSCN, Dr Tosan Erhabor which was delivered by Offutalu, Paulinus Nnamdi, the acting Director, IVD Department, MLSCN Abuja, the Registrar congratulated the management of the company for reaching the historic milestone by the establishment of the state-of-the-art facility and the launch of the On point Blood Glucose Monitoring System which underscore the remarkable strides in advancing healthcare solutions in Nigeria.

Dr Erhabor went further to explain why IVD validation, certification and Listing with MLSCN is fundamental “Pursuant to the Medical Laboratory Science Council of Nigeria (MLSCN) Act, CAP M25 LFN 2004 (Act 11, 2003) Sub-section 4 (d) and 4 (e), the Council is vested with the authority to regulate the production, importation, sales, and stocking of diagnostic laboratory reagents, chemicals, and equipment, including In-Vitro Diagnostic Devices (IVDs). We are glad to identify with this indigenous brand with local content but with international standards. In consonance with the above mandate, the MLSCN has established the Public Health In vitro Diagnostics Control Laboratory, Yaba, Lagos and the MLSCN IVD Technical Committee to enforce the regulatory mandate of MLSCN and to ensure sanity in the in vitro diagnostic regulation in Nigeria”.

Besides, the Registrar of MLSCN gave an insight into the performance of the company in the MLSCN IVD Laboratory as quoted in his speech,

“I am pleased to share that Codix Colexa Biosensor, in compliance with regulatory requirements, has submitted a number of IVDs for validation by MLSCN, including the groundbreaking OnPoint Blood Glucose Monitoring System, COVID-19 rapid test kits and PCR test kits that performed excellently well (See performance characteristics on our website: www.mlscn.gov.ng). Furthermore, I am delighted to inform you that after the rigorous process by our competent national validation team, the validation has found that the OnPoint GH82 Blood Glucose Monitoring System and Strips can satisfactorily perform glucose estimation in capillary blood by finger pricking, meeting the stringent standards set by MLSCN. Therefore, MLSCN has granted approval and authorized the marketing and use in Nigeria, for self – testing for Glucose estimation in capillary blood by finger pricking.

This new brand innovation by Codix aligns seamlessly with the values upheld by the Medical Laboratory Science Council of Nigeria to promote and strengthen diagnostic sector and health systems in Nigeria.”

He concluded his speech by calling on the stakeholders in the IVD and health industry to always visit the website (www.mlscn.gov.ng) for listed IVDs and to join hands with MLSCN in the promotion of quality IVDs and health system strengthening in Nigeria.

Mr Sammy Ogunjimi, the Executive Chairman of Colexa Biosensor Limited in his speech enumerated some achievements of the company to the guests present at the occasion.

He said commissioning of the Colexa Biosensor factory was the first of it’s kind in sub-saharan Africa. The first in Nigeria and sub-saharan Africa to manufacture IVD and Blood Glucose meter and strips and is expected to be the first in Nigeria to package a WHO pre-qualified HIV Rapid Test kit.

Mr Ogunjimi added that the factory is now ISO 13485:2016(IVD) Certified, the first in Nigeria and has recently received the ISO 9001:2015 Quality Management Certification.

The Chairman said the company is capable of providing direct employment for over 700 staff and several more indirectly.

Dignitaries at the event include Hon. Minister for Health and Social Development, Dr. Ali Pate, former minister for Health, Prof. Onyebuchi Chukwu, Pharm Lekan Asuni, the Executive Vice-Chairman of Colexa Biosensor Limited, Prince Julius Adewale Adelusi-Adeluyi, Chairman of the occasion, Hon. Commissioner Lagos State Ministry of Health, Prof. Akin Abayomi and his Ogun State counterpart Dr Tomi Coker, Hon. Benjamin Kalu, represented the Speaker House of Representatives, Director General, NAFDAC, Prof. (Mrs) Mojisola Adeyeye, HRM, Oba(Dr) Babatunde Adewale Ajayi, the Akarigbo of Remo Land and the Chairman, Ogun State Council of Obas, HRM, Oba (Dr) Kehinde Gbadewole Olugbenle, the Olu of Ilaro and Paramount Ruler of Yewa Land, Dr Evelyn Ngige, the Permanent Secretary, Federal Ministry of Industry, Trade and Investment and Barr. Jide Ogunkoya.