Trusted Authorised Representative Services for Medical Devices, IVDs, Cosmetics & PPE
Over 50 Years of Experience, supporting global manufacturers with tailored, compliant solutions across multiple regions.
Welcome to GBM Authorised Representative Services
We provide authorised representative services for the US (FDA), UK (MHRA), and EU (Notified Bodies), offering a cost-effective, efficient, and experienced solution. Our team manages annual product registrations and listings, and liaises with health authorities to report major product incidents when required.
Authorised Representative Services
We provide Authorised Representative services for:
- USA (FDA)
- UK (MHRA)
- EU (EUDAMED / Notified Bodies)
Covering regulated products including: Medical Devices & IVDs, Cosmetics, and PPE
Key services:
- Annual product registration & listing
- Incident reporting & Health Authority notifications
- FSCA guidance and manufacturer support
- Technical File maintenance & confidentiality assurance
A legal requirement for all non-local manufacturers placing regulated products on the market.
Why Use GBM Authorised Representative Services
- Cost-effective compliance solutions
- Efficient and responsive service
- Experienced team with over 50 years of combined expertise
- Fast turnaround times for urgent needs