Egypt’s fast-track medical device registration pathway reducing market access timeframes
Regulatory Updates | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- Egypt’s fast-track medical device registration pathway reduces CAPA premarket review timeframes to three months;
- Fast-track review is available for sterile and non-sterile disposable devices.
A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.
According to Emergo by UL consultants in Cairo, the Egyptian Central Administration of Pharmaceutical Affairs (CAPA)’s fast-track registration (see “Medical Device Registration Flowchart” link) can result in market approval in three months as opposed to more than one year via standard CAPA registration routes. Introduced in early 2018, the fast-track pathway applies to sterile and non-sterile disposable devices.
Steps in the CAPA fast-track process
CAPA’s fast-track review process entails the following steps:
- Compiling your device technical file;
- Requesting an application submission date from CAPA;
- Submitting your technical file to CAPA;
- Receiving review decision from CAPA within 90 days of submission.
“In some cases, device manufacturers’ requests for technical file submission dates to CAPA can take up to nine months, followed by review times that can take 12 to 15 months,” says Emad Elmasry, Managing Director, Middle East at Emergo by UL. “CAPA’s fast-track option can take only three months, so this provides a much faster commercialization option for qualifying devices.”