Regulatory Terms & Medical Compliance

Compliance Verification | Sultanate of Oman & GCC Directive Standards

Authorized Medical Device Distribution Standards:

All diagnostic equipment, surgical devices, and consumables supplied by Horizon Medical Technologies SPC comply with the regulatory clearance frameworks of the Ministry of Health (MoH) of the Sultanate of Oman and international ISO 13485:2016 quality standards.

1. Oman Ministry of Health (MoH) Registration

All active medical devices, including the CapsoCam Plus® capsule endoscopy platform and Artemis® targeted fusion biopsy systems, are imported and distributed strictly under authorized medical device establishment registrations and import permits issued by the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) / Ministry of Health Oman.

2. International Quality Accreditations (CE & FDA)

Horizon Medical Technologies only partners with global medical manufacturers whose production and design facilities maintain valid, audited certifications:

CE Mark: Certified compliance under European Medical Device Regulation (EU MDR 2017/745) for Class I, IIa, and IIb medical devices.
US FDA: 510(k) clearances for clinical efficacy, electrical medical safety, and electromagnetic compatibility.
ISO 13485:2016: Comprehensive quality management systems for medical device design, sterilization, storage, and traceability.

3. Biomedical Engineering Service Level Agreements (SLAs)

Horizon warrants that installation, commissioning, and preventative maintenance (PM) are executed exclusively by factory-trained biomedical service engineers residing in the Sultanate of Oman. Service terms provide:

Mandatory annual electrical safety inspections and calibrated accuracy verification compliant with MoH hospital audit requirements.
On-site emergency response within 4 hours for critical OR and diagnostic suite downtime within the Muscat Governorate.
Direct deployment of original manufacturer (OEM) replacement components and backup loaner consoles.

4. Institutional Procurement & Tender Terms

Quotations, proforma invoices, and tender submissions adhere to the commercial tender laws of the Sultanate of Oman. Official price schedules include complete certified training for biomedical staff, surgeons, and endoscopy nursing teams prior to formal hand-over.

5. Regulatory Inquiries & Certificate Requests

Hospital procurement committees, biomedical engineering departments, and DGMS auditors requesting copies of MoH registration certificates, CE declarations of conformity, or sterilization test reports may contact our regulatory affairs team at:

Horizon Medical Technologies SPC · Regulatory Affairs
Bait Al Reem, Way No. 3409, Building 81, Office 112, Al Khuwair, Muscat, Sultanate of Oman
Email: info@omanmedtech.com | Phone: +968 24 403781