Scientific Office Representation
Local regulatory representation for foreign manufacturers before EDA for medical devices and IVDs, within the applicable licensing framework.
All services / EDA & Regulatory Liaison
Manufacturer Representation.
ITD EGYPT / CAPABILITY 06
Manufacturer Representation.
Scientific Office Setup.
ITD Egypt supports foreign manufacturers seeking an official local regulatory presence in Egypt through the Authorised Scientific Office framework, subject to applicable EDA licensing and product-specific requirements. We support medical-device and IVD projects with local coordination, scientific-office representation, document management and clear regulatory follow-through before EDA. Responsibilities are defined for the specific product and engagement.
Discuss regulatory coordinationTHE SUPPORT WE PROVIDE
A Clear Scope.
Local Follow-Through.
Documentation & Submissions
Prepare, organise and coordinate regulatory documentation, dossiers, document-readiness checks and submission inputs.
Communication & Follow-Up
Coordinate meetings and EDA correspondence, track open queries and actions, and maintain local follow-up.
Lifecycle Tracking
Support registration milestones, renewals, post-registration activity and ongoing compliance coordination.
SCIENTIFIC OFFICE / EDA LIAISON
A Local Regulatory Presence.
A Clearly Defined Structure.
Scientific Office representation is subject to applicable EDA licensing and product-specific requirements. The office, personnel and manufacturer documentation must be confirmed for the agreed structure.
LOCAL SET-UPKey Scientific Office requirements
Setup checklist to confirm against the applicable EDA framework.
- Egyptian legal entity licensed to operate the Scientific Office.
- Official Scientific Office licence from the Egyptian Drug Authority (EDA).
- Dedicated Scientific Office premises in Egypt.
- Dedicated medical sample storage area of at least 25 m², compliant with EDA requirements.
- Appointment of a qualified Scientific Office Manager meeting EDA professional eligibility requirements.
- Appointment of a full-time licensed pharmacist responsible for the medical sample store.
- The same individual may perform both functions where permitted by EDA requirements and professional qualifications.
- Approved engineering drawings and layout plans for the Scientific Office and sample storage area.
- Valid lease or ownership documentation for the premises.
- Commercial Registration and relevant Egyptian corporate documentation.
- Required professional licences, syndicate registrations and employment documentation for responsible personnel.
- EDA inspection and approval of the premises where applicable.
- Publication of the Scientific Office licensing approval in the Egyptian Gazette, where required.
MANUFACTURER PACKForeign manufacturer documentation
- Official Letter of Authorization / Power of Attorney appointing ITD Egypt as the Authorized Scientific Office, ERH or Local Regulatory Representative.
- Authorization permitting ITD Egypt to represent the manufacturer before the Egyptian Drug Authority.
- Authorization permitting ITD Egypt to submit and manage medical-device or IVD registrations, where applicable.
- Manufacturer–Scientific Office Representation Agreement defining responsibilities and scope.
- Regulatory services / Scientific Office agreement between the manufacturer and ITD Egypt.
- Manufacturer corporate and legal documents.
- Manufacturing licences and regulatory certificates.
- Quality-management documentation, including relevant ISO certificates, where applicable.
- Free Sale Certificates, CE / market-authorization documentation or equivalent regulatory evidence where required.
- Product technical documentation necessary for EDA classification and registration.
- Documentation identifying the legal manufacturer and manufacturing sites.
- Appointment or coordination documentation for the licensed Egyptian importer / distributor, where required.
- Required documents legalized or authenticated by the relevant authorities, Chamber of Commerce and Egyptian Embassy / Consulate, where applicable.
WHAT ITD EGYPT CAN MANAGE
End-to-End Support.
Managed Locally.
The scope can cover representation and registration through renewals, import coordination and post-market support, tailored to the product, manufacturer and regulatory pathway.
01 / 10 SERVICESRepresentation & Registration
- ERH / Local Regulatory Representation before EDA and maintenance of appointment records.
- EDA Scientific Office representation.
- Medical-device and IVD registration support.
- Medical Device / IVD Classification Assessment.
- Regulatory Pathway Assessment.
- Technical Documentation Gap Assessment.
- Regulatory assessment, dossier review and technical readiness review.
- Preparation and coordination of EDA submissions.
- Submission management, follow-up, document coordination and client communication.
- Regulatory correspondence and authority liaison.
02 / 5 SERVICESDocumentation, Legal & Compliance
- Regulatory agreements, authorization templates and compliance support.
- Document management, regulatory record retention and controlled document tracking.
- Manufacturer documentation review.
- Regulatory Documentation Support.
- EDA inspection coordination.
03 / 9 SERVICESLifecycle, Import & Post-Market
- Registration amendments and variations.
- Registration renewal and regulatory maintenance.
- Import Approval Support.
- Customs Regulatory Support.
- Coordination with approved importers and distributors.
- Post-market vigilance coordination and escalation support.
- Regulatory follow-up and ongoing local representation.
- Post-registration regulatory support.
- Local regulatory administration, management and support infrastructure.
THE TEAM BEHIND THE SERVICE
Specialised People.
A Connected Service.
Regulatory Affairs Specialist Team
Regulatory assessment, dossier review, classification support and technical readiness review.
Regulatory Coordinator Team
Submission management, follow-up, document coordination and client communication.
Legal & Compliance Support
Regulatory agreements, authorization templates, compliance review and contractual support.
Document Management
Regulatory record retention, file organisation and controlled document tracking.
Vigilance Support
Basic post-market vigilance coordination and escalation routing.
Administration Team
Management, administration, local support infrastructure and commercial service coordination.
WHAT YOU CAN EXPECT
Define the Work.
Make Progress Visible.
Deliverables are tailored to the agreed engagement. They may include:
- A project scope and responsibility map
- A document-readiness and action tracker
- A correspondence and query record
- An agreed milestone and lifecycle register
HOW WE WORK TOGETHER
Clarify Products and Responsibilities
Define the product scope, intended activity and responsible parties, including any licensed delivery partners.
Coordinate Document Readiness
Organise and review documentation from manufacturers, partners, importers or distributors.
Track Correspondence and Open Actions
Manage meetings, EDA queries, correspondence, actions and follow-up.
Maintain Agreed Milestone Visibility
Track registration, renewal and other agreed regulatory milestones and timelines.
YOUR QUESTIONS
Before We Begin.
Who submits and holds the registration?
The submitting party, registration holder and any licensed delivery partner must be identified for the specific engagement. These responsibilities are confirmed as part of the agreed scope. Depending on the agreed structure and regulatory pathway, ITD supports local coordination, representation and the submission process in line with the applicable EDA framework.
What information should we share initially?
Start with basic product details, manufacturer information, existing regulatory status, the intended route to market and available technical documentation. ITD can then discuss the coordination required and the next information to obtain.
Are official costs part of the service scope?
The proposal should distinguish ITD’s service scope from applicable authority or third-party charges and identify which party is responsible for each. Legalisation, testing and other official or third-party costs are typically separate unless specifically included in the agreed proposal.
LOCAL ACCESS. GLOBAL STANDARDS. STRATEGIC EXECUTION.
Let’s Discuss
What Comes Next.
Regulatory note: Requirements and responsibilities are subject to the applicable Egyptian Drug Authority framework and may vary by product category, classification, manufacturer structure and agreed regulatory pathway.
OUR SIX CAPABILITIES