Distribution Search Support
One of the biggest challenges for a foreign manufacture decided to enter any new market is finding a qualified distributor for his product. The manufacture may face obstacles like different language, different culture and different time zone in addition to the time consuming process in selecting a distributor that matches his requirements. At the end, no guarantee that the selected distributor is the perfect match!
Because choosing the wrong distributor will lead to a significant loss in potential sales, damaging your brand name and your future success, H4T offers you a convenient solution at a reasonable price by identifying and selecting qualified distributors promoting your medical device in the entire Region
Contact H4T to learn more about our customized distributor search options!
Egypt's Registration Consultation
Before manufacturers can legally sell to, or within Egypt, they must be in compliance with the EDA regulatory requirements.
Currently The Egyptian Drug Authority (EDA) is responsible for regulating the safety and effectiveness of medical devices. Several “central departments” are established under the EDA, including the Central Administration for Medical Supplies. There is also the separate Egyptian Authority for Unified Drug Procurement, Medical Supply, and Medical Technology Management, who will handle all governmental hospital purchases of medical products.
There is no current legislation codifying the medical device regulatory requirements in Egypt, and most requirements are published throughout various Technical Committee Decisions or known from practical experience in the market. The EDA requires all medical devices, except Class I non-sterile devices, to be registered prior to import or sale in Egypt. Class I non-sterile devices do not require registration at this time. However, importation of medical devices of any class requires the manufacturer to be listed on the importer’s Importation Record and an Import Permit for each shipment of devices.
H4T however will assist you in preparing the submissions for device registration to EDA by Providing you with the registration checklist and templates needed for the submission, submit the complete technical file to EDA, submit your responds to EDA’s inquiries, following up with EDA till you get the registration license for your medical device.
Holding Registration Licence
For devices subject to registration, manufacturers without an office in Egypt must appoint a local operator as the Egyptian Registration Holder (ERH) to submit the registration application and act on their behalf in the country, including for importation and vigilance reporting. The ERH is responsible for coordinating the importation of a registered device, including obtaining an Import Permit for each shipment (or on an annual basis). The ERH must be properly licensed with the EDA to act in these capacities. It is possible to have multiple registrations through different ERHs (importers), if desired.
Alternatively, manufacturers with a local “Scientific Office” in Egypt can appoint this office as their ERH and must have proper business licenses in Egypt.
For devices that are not subject to registration, manufacturers must still appoint an importer, who will apply for the required Import Permits.
As per the current applicable rules by EDA the Product registration holder (ERH) will act as the initial importer for product into Egypt. This holds the (ERH) responsible about the product importation and vigilance in the market while distributor will only focus on selling and promotion activities.”
Some of the benefits of appointing H4T as your ERH:
- · You will need to provide access to your device technical information and documentation (mandatory for registration purposes) and most companies prefer not to leave (confidential) design information in the hands of their distributors.
- · The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warning when changes affect your devices.
- · Issuance of registration approvals by EDA in name of a distributor may limit your control over the device registration. The ERH is viewed by EDA as the “registration holder” and own the registration, including dictating if other distributors are allowed to import under the approval in their name. If you select Hadina 4 Trade (H4T) as the ERH, we will be identified on the registration approval and would fully cooperate with you so that you control the approval of your device on the market.
Inspection Support Service
When a distributor imports a medical device shipment, he would need to get it released from customs upon arrival to Egypt. Importation permit request has to be submitted and approved by importation department within EDA in Egypt based on a supplier’s Proforma invoice prior to shipment of the product. After goods release from customs, distributor will store them in his stores and waits for the EDA inspection committee to final release the shipment for sale in the market.
H4T can play a big role in this process as if the inspection didn’t go smoothly; distributor will get stuck and will not be able to sell anything from the imported goods. From our experience, very few distributor can manage the EDA inspection without fail.
Contact H4T if you need our help with the inspection services!
Post-Market Surveillance (PMS)/Vigilance
Medical device market surveillance is not only regulatory-driven, but also considered as good business practice. It helps the manufacturer to obtain an understanding of the performance of the device once placed on the market and provides continuous feedback that enables manufacturers to maintain a high standard of product quality and consumer satisfaction. It also helps to minimize exposure arising from incidents through effective warning and product recall processes and procedures.
PMS
The EDA collects and evaluates post-market information on medical devices, with a particular focus on adverse events/incidents and post-market vigilance.
VIGILANCE
Adverse Events/Incidents
If a device is involved in an incident, either the manufacturer or the ERH must immediately notify the EDA and then submit an incident report.
Only incidents occurring within Egypt are reportable.
In the event of a significant increase in the rate of adverse incidents associated with a particular device, the EDA may require the manufacturer to conduct periodic summary or trend reporting on the Manufacturers or ERH must also inform the EDA when an authority in another country requires periodic summary or trend reports for a device also marketed in Egypt.
Recalls/Field Safety Corrective Actions (FSCA)
FSCAs/recalls that affect devices marketed in Egypt must be notified to the EDA. Additionally, a Field Safety Notice (FSN) must be sent to the EDA, and then to device users. This may occur prior to submission of the FSCA form, depending on the urgency.
The purpose of medical device vigilance is to protect the health and safety of persons within Egypt; evaluate incidents to prevent recurrence; determine the effectiveness of corrective actions and preventive actions and monitor and learn from experience.