Introduction
IVD Manufacturing in Oman is becoming a key focus area for healthcare innovation and self-reliance. In-vitro diagnostic (IVD) devices play a vital role in disease detection, monitoring, and prevention, making their local production crucial for both public health and economic growth. For manufacturers, setting up an IVD facility in Oman requires a clear understanding of the manufacturing process, regulatory compliance, and business opportunities.
This guide explains the step-by-step process of IVD manufacturing in Oman, the MOH regulatory requirements, and how expert consultants like Operon Strategist can support you in establishing a compliant and profitable setup.
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Why Invest in IVD Manufacturing in Oman?
- Growing Healthcare Demand – Oman’s healthcare sector is rapidly expanding with government investments and rising diagnostic needs.
- Favorable Business Environment – Tax benefits, free zones, and government incentives support medical manufacturing projects.
- Import Substitution – Local production of IVD devices reduces dependency on imported diagnostic kits.
- Export Potential – Strategically located, Oman offers easy access to GCC, African, and Asian markets.
Step-by-Step IVD Manufacturing Process in Oman
Feasibility Study & Market Research
- Assess demand for IVD devices in Oman and export markets.
- Conduct a medical device product feasibility report for investors.
Facility Setup & Layout Design
- Establish cleanroom environments (ISO 14644 compliant).
- Plan a manufacturing plant layout design that meets MOH and ISO 13485 standards.
Raw Material Procurement & Testing
- Source high-quality raw materials for reagents, plastics, and electronic components.
- Conduct biocompatibility and sterility testing.
Production & Assembly
- Follow Good Manufacturing Practices (GMP) for IVD device assembly.
- Implement automation and QC systems for accuracy and consistency.
Packaging & Sterilization
- Use ISO 11607-compliant packaging.
- Ensure sterility through validated processes.
Regulatory Approval in Oman
- Register your IVD device with the Ministry of Health (MOH), Oman.
- Comply with ISO 13485, ISO 14971, and CE Marking if targeting exports.
Regulatory Compliance for IVD Devices in Oman
- Ministry of Health (MOH) Registration – All IVD devices must be registered before sale.
- ISO 13485 Certification – Ensures a strong quality management system (QMS).
- Risk Management (ISO 14971) – Identifies, evaluates, and mitigates risks.
- CE Marking & GCC Market Access – Required if exporting outside Oman.
- Labeling & UDI Requirements – Must comply with international traceability standards.
Business Opportunities in Oman’s IVD Sector
- Partnerships with hospitals and diagnostic centers.
- Supply of reagents and consumables.
- OEM manufacturing and export potential.
- Government-backed projects in healthcare manufacturing.
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Role of Operon Strategist in IVD Manufacturing Setup in Oman
At Operon Strategist, we provide end-to-end consulting services for IVD manufacturing projects in Oman, including:
- Feasibility reports and business planning.
- Facility setup with ISO-compliant cleanroom designs.
- Regulatory consulting for MOH registration & CE Marking.
- Support in documentation, validation, and certification.
- Training staff for ISO 13485 & GMP compliance.
We ensure your manufacturing unit is regulatory-ready, cost-efficient, and future-proof.