Expanded Medical Device Regulations in Egypt Set for September 2018
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Egypt’s Central Administration of Pharmaceutical Affairs (CAPA) will begin requiring registration for a broader swath of medical devices starting September 1, 2018.
- All Class I sterile, Class IIa, Class IIb and Class III devices will fall under CAPA oversight.
Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes.
As Emergo consultants in Cairo previously noted, CAPA had initially announced in early 2018 that a limited number of non-sterile devices would fall under the Egyptian registration requirements, but then expanded those requirements to all Class I sterile, Class IIa, Class IIb and Class III devices. (Previously, CAPA required registration only for sterile devices.)
CAPA’s new process for medical device registrations
Although Egyptian regulators have set a September 1 compliance deadline for their new registration requirements, CAPA cannot review all affected market applications by that date. Instead, CAPA has set up the following process:
- Companies must email CAPA to request an appointment to submit their registrations
- CAPA will respond to each company with a date and time to appear for registration submission;
- Provided that a company has submitted its appointment request, CAPA will continue issuing import permits allowing that company to market its devices in Egypt until formal registration gets underway.
Who should submit registration appointment requests to CAPA
CAPA requires appointment requests to be submitted by physical importers or independent representatives on manufacturers’ behalves.
In cases where manufacturers utilize two or more distributors in Egypt, three options are available.
First, each of a company’s distributors may submit a full technical file to CAPA and receive a valid registration in its name; multiple registrations for a single device are permitted.
Second, a company may opt to go through an Egypt Registration Holder with a licensed Scientific Office in Egypt. Under this scenario, a single device registration is centralized via the Scientific Office.
Third, a company may utilize an initial importer/resell model if they intend to manage a single registration on the Egyptian market.
What to include in a CAPA registration submission
Emergo’s Cairo office also now reports that CAPA has identified which materials Egyptian market registrants should include in their registration appointment requests to the regulator.
Companies have two options:
- They may include Declarations of Conformity, CE Mark certificates, ISO 13485 certifications and Certificates of Free Sale (CFS);
- Or they may include Certificates to Foreign Government (CFG) along with statements of compliance with US Food and Drug Administration Good Manufacturing Practices (GMP).
The materials listed above must be provided to CAPA when companies request their registration appointments. Full technical files including proprietary device information as well as any relevant test reports must be provided at the time of a company’s actual appointment with CAPA.
(Emergo sources report that CAPA is booking registration appointments nearly one year out from request dates, so companies should have enough time to prepare technical file materials.)
For the time being, Class I non-sterile medical devices as well as IVDs remain exempt from CAPA registration requirements. However, manufacturers should be aware that such exemptions are subject to change at CAPA’s discretion at any time.