Device Classification & Conformity Assessment
Accurate device classification is the foundation of a successful market entry. We expertly classify your medical device (Class I, IIa, IIb, or III) according to MENA regulatory requirements and international standards like ISO 13485. This ensures you follow the correct regulatory pathway for a smooth market entry, avoiding costly delays and rework. Our deep understanding of MENA-specific regulations ensures your device meets all local requirements.
Our comprehensive conformity assessment services include:
- Gap Analysis: Identifying any gaps in your device's compliance with essential requirements. Our thorough gap analysis identifies potential compliance issues early, saving you time and resources by addressing them proactively.
- Technical Documentation: Supporting the creation of complete Technical Files or Design Dossiers, tailored to MENA regulatory expectations.
- Notified Body Liaison: Acting as your liaison with Notified Bodies, streamlining the certification process.
Technical Documentation & Review
Our technical documentation services cover:
1. Technical File Compilation:
We compile detailed design, manufacturing, and performance data, ensuring completeness and alignment with recognized international standards (e.g., IEC 60601 for electrical medical devices).
2. Labeling & UDI Implementation:
We ensure your device labeling meets all MENA regulatory requirements, including local language and content specifications. We also support UDI implementation where required, ensuring compliance and smooth market access. Our expertise in MENA labeling requirements ensures your device's packaging and instructions for use are compliant in all target markets.
Market Access Strategies
- Product Launch & Promotional Approvals
We handle the regulatory complexities of launching your medical device in MENA, securing approvals for your marketing materials and ensuring compliance with local regulations and ethical codes. This allows you to confidently communicate your device's benefits to healthcare professionals and patients. We assist in obtaining approvals for marketing and promotional materials, ensuring that device claims are scientifically substantiated and comply with ethical codes..
Your in-country representative services include:
- Acting as a liaison Represents the foreign manufacturer before local regulatory authorities.
- Managing communication with regulatory authorities and customs offices.
- Responding to all pre-certification and post-approval inquiries.
- Handling adverse event reporting, recalls, and other post-market obligations
Post-Market Surveillance
- Proactive Vigilance Management
We establish and manage robust vigilance systems to proactively monitor your device's performance, identify potential adverse events, and implement corrective actions before they escalate. This ensures compliance with MENA health authority requirements and safeguards patient safety.
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