Medical Device Classification

Accurate categorization to determine precise regulatory requirements.

Built for Teams Needing Regulatory Certainty

We help manufacturers, innovators, and distributors define the correct device category before investing in submissions, testing, or market entry plans.

Device Manufacturers

Confirm the correct classification before building your regulatory pathway or technical file.

SaMD & Digital Health

Clarify how software, AI, and connected health products fit within medical device frameworks.

IVD Companies

Determine classification and evidence expectations for diagnostic products and related systems.

Market Entry Teams

Avoid submission delays by aligning device type, risk class, and regulatory requirements early.

Classification That Guides Every Next Step

A focused assessment that converts product details, intended use, and risk profile into a clear regulatory classification position.

Intended Use Review

Analyze claims, indications, users, and clinical context to understand how the product should be regulated.

Risk Class Determination

Map product risks to applicable SFDA, GCC, and international classification principles.

Borderline Product Analysis

Assess combination, wellness, software, and novel products where classification may not be obvious.

Regulatory Pathway Mapping

Translate classification outcomes into practical documentation, testing, and submission requirements.

Classification Rationale Report

Document the classification logic clearly so internal teams, partners, and authorities can follow the decision.

How We Work

A structured classification process that gives your team a clear regulatory starting point before submission work begins.

Discover

Review product design, intended use, claims, and target markets.

Analyze

Compare device characteristics against relevant classification rules and guidance.

Classify

Determine the likely device category, risk class, and regulatory route.

Document

Prepare a concise rationale that supports the classification position.

Apply

Use the outcome to guide technical file, testing, and authorization planning.

Key Deliverables

Clear outputs that drive compliance, reduce risk, and accelerate your time to market.

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05 Build a Complete Regulatory Ecosystem .

LexoraMed provides integrated regulatory support across Saudi Arabia, GCC, and global markets — helping manufacturers move from strategy to authorization with confidence and clarity.

Medical Device Market Authorization

Advisory on securing MDMA, SFDA approvals, and global authorization pathways for regional and international market entry.

Technical File Assessment

Comprehensive review and audit of technical documentation for market authorization.

QMS for ISO 13485 Certification

Building manufacturer Quality Management Systems ready for ISO 13485 certification.

Frequently Asked Questions

Clear answers to the most common regulatory and compliance questions manufacturers ask before entering Saudi Arabia and global markets.

When should classification be completed? +

Classification should be completed early, before technical file planning, testing strategy, or market authorization work begins.

Can you classify software or AI medical devices? +

Yes. We assess software, AI, and digital health products using intended use, clinical function, and risk-based classification principles.

What if our product is borderline? +

We prepare a structured rationale that compares product claims, function, and risk against relevant regulatory definitions and rules.

Does classification define the full approval pathway? +

It is the starting point. The classification result guides documentation, evidence, testing, and market authorization requirements.