Regulatory · Quality · Compliance
Built to Global Standards.
Certified to Prove It.
Every product that leaves this facility has been manufactured under a quality management system that meets or exceeds the requirements of NAFDAC, ISO, WHO, and international regulatory bodies.
Operational. Verified.
Non-negotiable.
These certifications are not aspirational. They are active, operational, and the foundation on which every product that leaves this facility is built.
ISO 13485:2016
Medical Devices Quality Management System
The internationally recognised standard specifically designed for organisations involved in the design, production, installation, and servicing of medical devices. ISO 13485 is the benchmark that regulators worldwide, including the FDA, CE marking bodies, and Health Canada rely on to assess whether a medical device manufacturer can be trusted.
For NASENI-TROMENT, ISO 13485 certification covers the full production cycle, from raw material procurement through manufacturing, testing, packaging, and distribution. It governs every process that touches the N-CheckUp product line.
Scope of Certification
- Design and development of rapid diagnostic test kits
- Manufacturing and production processes
- Quality control and testing procedures
- Packaging, labelling, and storage
- Post-market surveillance
ISO 9001:2015
General Quality Management System · US-Notified Body
The world's most widely recognised quality management standard, applicable across all operational functions, not just production. ISO 9001 governs administrative processes, supply chain management, customer feedback systems, and continuous improvement programmes.
NASENI-TROMENT's ISO 9001 certification is awarded by a US-notified body, providing additional weight in international regulatory submissions and procurement processes, particularly for export to North American and European markets.
What ISO 9001 Covers
- Context of the organisation and stakeholder needs
- Risk-based thinking and preventive action
- Leadership commitment to quality
- Operational planning and control
- Performance evaluation and improvement
NAFDAC
National Agency for Food and Drug Administration and Control · Factory & Products Certified
NAFDAC is Nigeria's primary regulatory body for food, drugs, cosmetics, medical devices, packaged water, and chemicals. NAFDAC certification is mandatory for any medical device to be sold legally in Nigeria, and it represents the Nigerian government's stamp of approval for both the manufacturing facility and the products it produces.
NASENI-TROMENT holds both factory certification, meaning approval of the manufacturing facility itself, and product registration for 26+ N-CheckUp diagnostic products. This dual certification is the foundation for all commercial activity in the Nigerian market.
Products Registered
- 26+ products submitted and registered
- 13 professional-use kit lines
- 13 self-test / home-use kit lines
- Covering: Malaria, HIV, Hepatitis B&C, COVID-19, Typhoid, Syphilis, Chlamydia, Pregnancy, and more
Opening the
global market.
These registrations are in their final stages. When complete, they will unlock NASENI-TROMENT's access to international procurement bodies, global health organisations, and markets across North America and beyond.
WHO Pre-Qualification (WHO PQ)
World Health Organization · Pre-Qualification Programme for In Vitro Diagnostics
WHO Pre-Qualification is the gateway to global procurement. It is the standard required before a diagnostic product can be purchased by UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Médecins Sans Frontières (MSF), USAID, and other major international health procurement agencies.
For NASENI-TROMENT, WHO PQ represents the pathway from a nationally registered manufacturer to a globally procured supplier. It transforms the N-CheckUp brand from a Nigerian product into an internationally available tool for public health.
What WHO PQ Unlocks
Health Canada Registration
Health Canada · Medical Devices Directorate · Class III Medical Device Licence
Health Canada is Canada's federal health authority, responsible for regulating medical devices for safety, effectiveness, and quality. Registration with Health Canada provides access to the Canadian market, one of the world's most rigorously regulated healthcare environments.
Critically, Health Canada approval is recognised by multiple international regulatory bodies as a reference standard, facilitating market access in additional jurisdictions beyond Canada. The Samir Hani Group's existing commercial operations in Canada provide established infrastructure for market entry.
What Health Canada Registration Unlocks
We don't operate
under license.
We own the technology.
Through the complete technology transfer from Vision Biotechnology, NASENI-TROMENT holds full ownership of all scientific files and intellectual property for its product portfolio. This is not a manufacturing arrangement where rights revert to a foreign licensor. This is genuine, unrestricted ownership.
Product dossiers for the N-CheckUp portfolio are registered in Germany, the United States, Turkey, and across Western Europe, providing the regulatory foundation for international market expansion.
Full IP Ownership
Complete ownership of all scientific files, formulations, and product specifications. No licensing fees. No expiry of rights. Permanent.
N-CheckUp Trademark Registered
The N-CheckUp brand name and identity are formally trademarked. Full brand protection across Nigerian and international markets. A proud Nigerian brand, owned by Nigerians.
Dossiers Registered in Key Markets
Product registration dossiers filed and approved in Germany, United States, Turkey, and Western Europe, enabling rapid regulatory submission in additional markets that accept these as reference standards.
500+ Product Portfolio in Pipeline
The registered dossiers and owned IP cover a pipeline of over 500 diagnostic products, forming the foundation for progressive market expansion as regulatory approvals are secured in new geographies.
Questions about our
certifications or compliance?
Our Regulatory Affairs team is available to answer questions from procurement officers, government agencies, NGOs, and international partners about our certification status, product dossiers, and registration pipeline.
Contact Regulatory Affairs