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Resources/Articles/Updated January 2026

Evidence & readiness articles.

Analytical content on evidence and readiness: evidence maps, readiness indicators, gap statements, and remediation plans. Where examples are included, they are composite or redacted to remove sensitive data.

|Guides|21 min read|RegDossier Cloud TeamLatest

SFDA Medical Device Marketing Authorization (MDMA): Evidence Requirements, Submission Essentials, and Post-Market Obligations

In this context, manufacturers and distributors must navigate both global expectations and SFDA-specific requirements to successfully register a device. SFDA’s regulatory system is strongly influenced by international best practices and harmonization efforts, aligning Saudi requirements with global standards. However, local specifics – from documentation format to post-market vigilance – demand careful attention. This article provides a detailed overview of the evidence expectations, submission requirements, common pitfalls, and opportunities for local manufacturers in obtaining an SFDA Medical Device Marketing Authorization (MDMA).

Guides
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|Samples|5 min read

Sample output (example)

Example report sections and evidence map format, illustrating what stakeholders receive without exposing sensitive details.

Output sample

Report sections

  • Readiness score and summary findings.
  • Critical gaps with evidence references.
  • 30/60/90 day plan aligned to program stages.

Evidence map snapshot

  • Program area: Governance -> Evidence: Board charter (details removed).
  • Program area: Operations -> Evidence: SOP excerpt (details removed).
  • Program area: Measurement -> Evidence: KPI dashboard snapshot (details removed).

Details omitted

  • Personal data and confidential identifiers.
  • Scoring criteria details.
  • Client-specific details or proprietary data.

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We provide sector-specific examples with sensitive details removed during a guided demo after confirming the program track.

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|Samples|6 min read

Case narrative (composite)

A composite walkthrough of how a regulated team maps evidence, clarifies ownership, and prepares for a review cycle.

Narrative

Context

A mid-size regulated organization needed to align evidence across multiple regulatory tracks while preparing for an upcoming review cycle.

Challenges

Evidence lived across shared drives, ownership was unclear, and leadership lacked a consistent readiness view.

Approach

The team used a guided intake to map evidence, assign owners, and derive a readiness score for leadership review.

Outcome

Stakeholders received a clear gap list, a defensible evidence map, and a focused 30/60/90 action plan.

Disclosure

  • Composite example for illustration only.
  • No client data is included.
  • Outcomes are qualitative, not guaranteed results.
Read narrative
|Guides|4 min read

Readiness checklist

A quick pre-demo checklist for evidence, ownership, and review cadence so the conversation stays precise and actionable.

Checklist

Evidence readiness

  • Identify 5-10 representative documents per program area.
  • Confirm owners for each evidence set and approval status.
  • Remove personal data or share samples with sensitive details removed for the demo.

Governance and workflow

  • Clarify who signs off on submissions and review cycles.
  • List current tools used for evidence storage or tracking.
  • Capture any upcoming audit or submission deadlines.

Security and privacy

  • Confirm data residency expectations and hosting constraints.
  • Note any compliance frameworks that matter for procurement.
  • Prepare security contacts for diligence follow-ups.
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