Local Representation Services for Global Compliance
This service ensures foreign manufacturers have a legal, competent, and locally fluent presence required by Health Authorities (HAs) worldwide, ensuring compliance, quick communication, and full market access.
1. Regulatory & Registration Holding Services
These roles are mandatory for maintaining product licenses and communicating with local HAs.
| Market/Region | Mandatory Role | Key Responsibilities |
| UK/ European Union (EU/EEA) | UK/EU Authorized Representative (EC-REP) (Medical Devices/IVDs) | Legal point of contact for HAs; required for MAA’s and CE Marking. |
| United States (US) | US Agent (FDA) | Formal point of contact for the FDA; responsible for communications, scheduling inspections, and receiving emergency information. |
| India | Indian Authorized Agent (IAA) / Importer | Mandatory legal entity responsible for product registration, import license applications, and liaison with the CDSCO (Pharma and Medical Devices Rules, 2017). |
| Other Territories (Africa) |
Local Registration Holder (LRH) / License Holder | Holding the product registration (license) in the country’s name, allowing the manufacturer to manage distribution without dependency on a single commercial partner. (Common in AFRICA, APAC, LATAM, and Middle East). |
2. Comprehensive Support and Liaison
- HA Liaison & Communication: Acting as the primary, official point of contact for all regulatory queries, inspections, and correspondence from local Health Authorities in the local language and time zone.
- Documentation Host: Maintaining a complete and accessible copy of the MAA Applications/ Dossiers, Technical File, Declaration of Conformity, or other necessary documentation for immediate review by local authorities.
- Post-Market Surveillance (PMS): Coordinating the local collection and submission of Post-Market Clinical Follow-up (PMCF) data, complaints, and device/drug vigilance reports.
- Audit & Inspection Readiness: Ensuring the local systems, processes, and documentation are prepared for regulatory audits and inspections by the local HA.
Why Choose Our Local Representation Services?
- No Conflict of Interest: We act purely as your regulatory and vigilance agent, separate from any commercial distributor, giving you full control over your product registration and distribution network.
- Availability: Ensuring continuous, rapid response to urgent safety and regulatory communications across all time zones.
- Global Network, Local Expertise: Leveraging a central system for quality and governance while utilizing in-country specialists who are fluent in local language, law, and regulatory culture.