17 December 2025
The Egyptian Drug Authority (EDA) announces the issuance of import approvals for refurbished spare parts for medical and laboratory equipment that are not classified as standalone devices.
When companies import refurbished medical and laboratory spare parts (Not classified as standalone devices), they must submit the following documents, in addition to the regulatory documents required for import approval as specified in the published regulatory guidelines for each equipment type:
- Proforma Invoice: Must include a refurbishment symbol, the spare part reference number, and the serial number or batch number to ensure traceability.
- Importer Registration: The license must include the manufacturer or supplier. In cases where the Refurbisher is different from the manufacturer, documented evidence of the relationship between the manufacturer and the Refurbisher must be provided.
- ISO 13485:2016 Certificate: Must cover the scope of refurbishment, or an official confirmation letter from the issuing certification body stating that the refurbishment scope is included. If an ISO 13485:2016 Certificate is not available, a Good Refurbishment Practice (GRP) certificate for the refurbisher, issued by a certification body, is mandatory.
- Refurbishment Certificate: Must include refurbisher details and refurbished spare part details, confirming that the spare part has been refurbished, tested, and complies with the manufacturer’s specifications. (This must be issued by the legal manufacturer of the device and submitted via the following email: md.certificate@edaegypt.gov.eg).
- Labeling: The label must include a symbol indicating that the part has been refurbished, consistent with the symbol stated on the invoice.