Authorized Rep
Authorised Representative Solutions For Medical Devices
RegTrac provides Authorised Representation in the worldwide markets with global presence and extended partner network.
- Product Registration / Notification
- Communication Liaison with Regulatory Bodies
- Query Resolution with Health Authorities
- Verification of Technical Documentation
- Quarterly Reports with Regulatory Updates
- Continuous Product Compliance
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UK RepresentationResponsible Person for MedTech Manufacturers in the UK with compliance to UK MDR 2002 (as amended)
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MDTF DocumentationKeep a copy of up-to-date and comprehensive technical documentation & DOC for inspection by MHRA
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Regulatory LiaisonPrimary contact point on product regulatory queries for MHRA | Approved Bodies | Healthcare Professionals | Consumers
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Vigilance ReportingManage incident reporting and safety updates to the authorities
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ComplianceRegulatory compliance to UK MDR 2002 (as amended)
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RegistrationsProduct registration with MHRA Free Sale Certificate (FSC) Support
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EU RepresentationAuthorised Representative for MedTech Manufacturers in the EU with compliance to EU MDR 2017/745 and EU IVDR 2017/746
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MDTF DocumentationTechnical File preliminary review and ensure conformity assessments are complete and DOC | CE Certification in place
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Regulatory LiasonPrimary contact point on product Regulatory queries for CA | Notified bodies | Healthcare professionals | Consumers
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Vigilance ReportingManage incident reporting and safety updates to the authorities
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ComplianceRegulatory compliance to EU MDR 2017/745 and EU IVDR 2017/746
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EUDAMEDActor Registrations and Product Registrations in EUDAMED
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Swiss RepresentationAuthorised Representative for MedTech Manufacturers in the Swiss with compliance to Swiss MedDO | IvDO
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MDTF DocumentationTechnical File preliminary review and ensure conformity assessments are complete and DOC | CE Certification in place
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Regulatory LiasonPrimary contact point on product regulatory queries for Swissmedic | Notified Bodies | Healthcare Professionals | Consumers
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VIGILANCEManage incident reporting and safety updates to the authorities
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ComplianceRegulatory compliance to Swiss MedDO | IvDO
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RegistrationManufacturer mandate | Product registrations as applicable
Authorised Representative Solutions For Cosmetics
RegTrac provides comprehensive Responsible Person services for cosmetic products, ensuring compliance and worldwide market access..
- Product Notifications
- Communication Liaison with Regulatory Bodies
- Query Resolution with Health Authorities
- Product Information File (PIF) Review
- Quarterly Reports with Regulatory Updates
- Continuous Product Compliance
UK RP
EU AR
RegTrac offers comprehensive Cosmetic Responsible Person services in UK
We specialize in providing full range of Cosmetic product compliance including PIF creation | Safety assessments | Claim substantiation | Labelling | Artwork | Responsible Person services.
Ready to take the next step? Let’s connect and explore how RegTrac can elevate your compliance journey.
RegTrac provides Cosmetic Responsible Person services in European Union
We offer one stop solution for complete cosmetic product compliance in European Union including PIF creation | Cosmetic Product Safety Report (CPSR) | Claim Substantiation | Labelling | Artwork | Responsible Person services.
Ready to take the next step? Let’s connect and explore how RegTrac can elevate your compliance journey.
Not sure which solution fits your needs? Our regulatory experts offer a free 30-minute consultation to assess your product, target markets and compliance gaps — with no obligation and no sales pressure.