Authorised Representative Services

Trusted Regulatory Compliance for Global Market Access

For manufacturers based outside their target market, appointing a local Authorised Representative (AR) is not just a best practice—it’s a legal requirement. At GBM Health Care, we offer fully compliant, reliable Authorised Representative services for companies looking to distribute regulated products across the USA, UK, and EU.

Markets We Cover

We act as your official point of contact with health authorities, helping you meet market-specific regulatory requirements in the following regions:

• USA – Food and Drug Administration (FDA)
• UK – Medicines and Healthcare products Regulatory Agency (MHRA)
• EU – EUDAMED / Notified Bodies

Products We Support

Our services cover a range of regulated product types, including:

• Medical Devices & IVDs (In Vitro Diagnostic Devices)
• Cosmetics
• Personal Protective Equipment (PPE)

Whether you're launching a Class I medical device or a new cosmetic range, our team ensures your compliance obligations are met with precision and confidentiality.

Our Authorised Representative Services Include

• Annual Product Registration & Listing
  Ensure your products are correctly registered with the appropriate regulatory bodies each year.
• Incident Reporting & Health Authority Notifications
  We act swiftly and professionally to report adverse events or non-conformances, helping to mitigate risk and protect your brand.
• FSCA (Field Safety Corrective Action) Guidance and Manufacturer Support
  We provide expert guidance on Field Safety Notices and work closely with you to implement corrective actions efficiently.
• Technical File Maintenance & Confidentiality Assurance
  We securely maintain your technical documentation and ensure readiness for inspections or audits, with strict confidentiality controls.

Why GBM Health Care?

With extensive experience across international regulatory frameworks, GBM Health Care serves as a trusted extension of your compliance team. We don’t just meet the minimum—we go beyond:

• Deep understanding of regional requirements and processes
• Direct liaison with local authorities
• Transparent, responsive communication
• Proven track record across multiple product categories

Legal Requirement for Market Access

Non-local manufacturers must appoint an Authorised Representative to legally place their products on the market. Our services ensure you meet this requirement while reducing regulatory burden and risk.

Let’s Get You Compliant

If you’re planning to enter or expand into the US, UK, or EU markets, we’re here to help you do it right.

Contact us today to learn more about our Authorised Representative services or request a consultation.