Changes to medical device registration in Egypt announced

March 22, 2013 by MassDevice

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Global Medicine

By Stewart Eisenhart, Emergo Group

Egypt's Central Administration for Pharmaceutical Affairs (CAPA), the country's medical device market regulator, has published a series of updates and amendments to its registration requirements on its website.

Among the more significant changes are:

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  • Voluntary CAPA registration for Class I non-sterile/non-measuring devices
  • Allowance for applicants to query CAPA about their registration dossiers within 10 days of submission
  • A 60-day limit for fulfilling all requirements related to CAPA registration (missing this deadline will result in voiding requests for registration).
  • List of reference countries accepted by CAPA expanded to include all European Union member states as well as the US, Canada, Japan and Australia

In addition, CAPA requires that the first shipments of all sterile medical devices from either reference or non-reference countries must be submitted for analysis by the National Organization for Drug Control and Research before those products can be sold in the Egyptian market.

CAPA has also loosened requirements for technical file submissions. Registrants no longer have to include biocompatibility test reports and stability studies, and legalization of declarations of conformity is no longer required.

By easing some requirements, expanding its list of reference countries and accelerating some registration deadlines, CAPA has taken steps to simplify the medical device approval process in Egypt

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.