The Egyptian Drug Authority (EDA) announced that, as of January 2 2024, both foreign importers and manufacturers wishing to market unregistered Medical Devices in Egypt must submit an application.
The Importer’s application must contain information about the Medical Devices, which the organisation intends to market in Egypt, such as name, models and codes.
In particular, the applicant must confirm that the listed Medical Devices have not been subject to recall procedures, field safety warnings or field safety corrective actions in the last three years, or, if such procedures have occurred elsewhere in the world, the Egyptian regulatory authority must be informed.
With regard to timing, EDA emphasises that incidents, which may pose a possible threat to public health, must be reported within one day. If an adverse event leads to the death or worsening of the patient’s condition, the Egyptian regulatory authority must be notified within 10 days of the event. Other adverse events must be reported within 15 days. The applicant must also undertake to continuously monitor its Medical Devices after marketing and to fulfil all necessary requirements for post-market surveillance.
Concerning the Manufacturer‘s application, the information to be reported is the same as for the importer but, in addition to confirming the existence of a post-market surveillance system, the manufacturer must ensure that local distributors carry out all post-market activities following the requirements. In addition to this, the manufacturer shall authorise the Importer/Distributor to place Medical Devices on the market.
The objective of the Egyptian regulatory authority is to strengthen import regulations in order to encourage the dissemination of safe and effective Medical Devices in the country.
>>> If you want to market Medical Devices in Egypt, Thema can assist you with the Strategic-Regulatory Consulting service, and support you in the registration of Medical Devices with EDA.
Source
