Most Common Delay Reasons

1. Improper Document Attestation

In some cases the authority requests the Free Sale Certificates should be legalized.

2. Inconsistent Labeling Information

Model numbers, intended use, and IFU must match submitted technical file.

3. Missing Post-Market Surveillance Plan

MOHAP increasingly focuses on post-market compliance.

4. Delayed Response to Committee Queries

Regulatory timelines depend on prompt replies.

How to Prevent Delays?

• Pre-submission document audit
• Technical gap analysis
• Centralized tracking of committee inquiries
• Proactive renewal monitoring