Authorized Representative Services

Acting as your local legal liaison across regional markets.

Built for Manufacturers Needing Local Representation

We support international medical device and IVD companies that require a reliable local regulatory presence across Saudi Arabia and regional markets.

International Manufacturers

Establish compliant local representation before entering Saudi Arabia and GCC markets.

Global MedTech Brands

Coordinate authority communication, documentation, and post-approval obligations through one accountable local partner.

IVD & Device Companies

Maintain market access support for regulated products requiring regional representation.

Expanding Distributors

Align commercial market entry with the regulatory duties expected from local representatives.

Representative Support Across the Product Journey

A structured local liaison service that keeps regulatory communication, documentation, and ongoing obligations clear and controlled.

Local Regulatory Liaison

Act as the local point of contact for authority communication, documentation requests, and regulatory coordination.

Market Entry Coordination

Support authorization activities by aligning manufacturer files, local requirements, and regional submission expectations.

Compliance Document Control

Maintain clear records, declarations, and representative documentation needed for regulated market access.

Authority Communication Support

Coordinate responses, clarifications, and follow-up actions with regulatory bodies in a timely and structured way.

Post-Authorization Oversight

Support ongoing representative duties after approval, including change notifications and compliance follow-up.

How We Work

A clear representative model that helps international manufacturers manage local obligations with confidence.

Assess

Review your products, market plans, and local representation requirements.

Align

Define roles, responsibilities, documentation scope, and communication channels.

Prepare

Compile representative documents, declarations, and supporting regulatory records.

Coordinate

Manage authority communication and submission-related follow-up with your team.

Maintain

Support ongoing obligations, product changes, and post-approval compliance activities.

Key Deliverables

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

01

02

03

04

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.

Who needs an authorized representative? +

International manufacturers often need a local regulatory liaison before placing medical devices or IVDs on regional markets.

Can LexoraMed communicate with authorities on our behalf? +

Yes. We support structured authority communication, follow-up, and documentation coordination within the agreed representative scope.

Does this replace the manufacturer’s responsibilities? +

No. The manufacturer remains responsible for product compliance, while LexoraMed supports local representation and regulatory coordination.

Can this service support post-approval changes? +

Yes. We can support change notifications, documentation updates, and ongoing representative obligations after authorization.