Transfer of Registration Licences between Holders in Egypt Explained

1. Key takeaways

Egypt permits registration licences to move between holders, and the guideline describes three scenarios: transfer from an agent or distributor to a scientific office (imported devices), transfer to an affiliated scientific office, and a change of the applicant’s name (address unchanged). Using the first as the example, the core documents include: payment receipt for the variation service fee; the original power of attorney of the applicant’s representative (approved by the chairman of the board, whose signature is authenticated by the bank or the EDA’s legal administration, and stating that the representative is entitled to receive the original registration licence); the undertaking to comply with the device vigilance system (per the Egyptian Vigilance Center announcement of 1 August 2023); the original valid registration licence; the scientific office licence; the manufacturer’s authorisation letter (authenticated by the chamber of commerce and the Egyptian embassy); the waiver of the original applicant (chairman-approved, signature authenticated by the bank or the EDA’s legal administration); and the approval letter allowing the scientific office to register devices in the interest of the legal manufacturer (issued by the evaluation department).

In substance, a transfer is a three-party consent exercise plus surrender of the original licence, not a simple contract change. Missing any document defeats the transfer, so the three parties’ documents should be prepared in parallel.

2. Legal basis

3. Expert insights

Insight 1: the essence of a transfer is three-party consent plus surrender of the original licence, not a simple contract change.

The document list simultaneously requires the manufacturer’s authorisation letter (to the new holder), the letter of termination of the agreement with the original applicant issued by the legal manufacturer (authenticated by the chamber of commerce and the embassy), and the waiver of the original applicant. All three parties must state their position in writing. If any one document is missing, the transfer does not stand.

Insight 2: the announcement dates cited for the vigilance undertaking differ between registration and variation — verify each separately.

The registration stage (item 3 of Appendix 1 of GL.CAMD.002) cites the announcements of 24 April 2018 and 8 August 2019, whereas the licence transfer (Section 8 of GL.CAMD.003) cites the Egyptian Vigilance Center announcement of 1 August 2023. The dates belong to different procedural nodes, and companies must select the version matching the procedure they are in when issuing the undertaking.

Insight 3: two authentication routes are offered — the bank or the EDA’s legal administration.

Items B and C of Section 8 both speak of the bank or the EDA’s legal administration attestation of the chairman’s signature. This offers an alternative where bank authentication is inconvenient outside Egypt, but attestation by the EDA’s legal administration must be completed inside Egypt.

Insight 4: where the scientific office licence names the parent company, the relationship must be explained additionally.

Item 5 of item B of Section 8: the scientific office licence must state the manufacturer’s name; where the licence names the parent company, the scientific office must submit a letter explaining the relationship between the entity named in the licence and the legal manufacturer, and the relationship must be authenticated by the chamber of commerce and the Egyptian embassy in the country of origin. This runs in the same direction as the registration-stage requirement for scientific offices (a no-objection letter from the parent company), but here a relationship explanation is required.

Insight 5: the affiliated scientific office scenario requires proof of two layers of relationships.

Item C of Section 8 requires: (1) an authorisation letter, service agreement or registration service agreement between the scientific office and the manufacturer, or between the original applicant to which the scientific office is affiliated and the manufacturer named in the scientific office licence, explaining the scientific office’s capacity to handle registration in Egypt and stating the devices whose licences are to be transferred (or all devices), authenticated by the chamber of commerce and the Egyptian embassy; and (2) proof of the contractual relationship between the scientific office and the original applicant to which it is affiliated (authorisation, authorisation agreement or authorised services), with the chairman’s signature authenticated by the bank or the EDA’s legal administration. Two relationships, two authentication routes.

Insight 6: the fallback for a failed transfer is a new registration plus a one-year import grace period.

At the end of item A of Section 8: where any of the required documents cannot be submitted, the new applicant must submit a new registration application, but a one-year grace period to import the device is granted from the acceptance of the documents by the device evaluation administration; the reason given is that the device is already circulating in the Egyptian market and difficulties of use should be avoided. It is a pragmatic transitional arrangement, but its cost is running registration again.

Insight 7: item C also requires an approval letter issued by the evaluation department.

Item 9 of item B and item 8 of item C both require the approval letter allowing the scientific office to register devices in the interest of the legal manufacturer (issued by the evaluation department). Registration through a scientific office therefore needs an internal EDA pre-approval, not just a bilateral agreement.

4. Practical recommendations

1. Lock the scenario before starting: agent or distributor to scientific office, to affiliated scientific office, or a change of applicant name.
2. Prepare the three-party documents in parallel: manufacturer authorisation letter, termination letter for the original applicant agreement, and the original applicant’s waiver.
3. Choose one authentication route and schedule it early: bank authentication or attestation by the EDA’s legal administration.
4. Select the vigilance announcement version by procedure: 2018 and 2019 for registration, 1 August 2023 for transfer.
5. Where the scientific office licence names the parent company, add the relationship explanation and authenticate it.
6. Prepare two layers of relationship proof for the affiliated scientific office (chamber and embassy authentication plus bank or legal administration authentication).
7. Start the new registration plus one-year grace period fallback immediately if documents are incomplete.

5. Verification checklist

• □ The transfer scenario has been determined (item B or C, or a name change)
• □ The payment receipt for the variation service fee has been obtained
• □ The original power of attorney of the applicant’s representative (approved by the chairman; signature authenticated by the bank or the EDA’s legal administration; stating the right to receive the original licence)
• □ The vigilance system compliance undertaking has been issued per the 1 August 2023 announcement
• □ The original valid registration licence has been surrendered
• □ The scientific office licence states the manufacturer’s name (or the parent company relationship explanation has been added)
• □ The manufacturer’s authorisation letter is authenticated by the chamber of commerce and the Egyptian embassy
• □ The original applicant’s waiver (chairman-approved; signature authenticated by the bank or the EDA’s legal administration) has been obtained
• □ The evaluation department approval letter allowing the scientific office to register has been obtained

Regulatory information verified as of 29 October 2026. The registration licence transfer requirements described here follow the current text of items A, B and C of Section 8 of EDREX: GL.CAMD.003 Version 3.

• Local resource in Egypt: GRZAN assists manufacturers from the Chinese mainland and other overseas markets in engaging the Egyptian Drug Authority (EDA) for medical device registration, import approvals and variation applications, including design of the registration applicant scheme (importing company, local factory or scientific office), preparation for scientific committee evaluation, analysis of pathways for obtaining free sale certificates from reference countries, Arabic localisation of labels and instructions for use, and setup of vigilance systems and periodic reporting.
• Service capabilities: product attribute determination and risk classification (devices Class I–III / IVD Class A–D), registration and re-registration, applicability assessment of system registration and bundled registration, three-category variation determination, import approvals and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; info@grzanglobal.com; website www.grzan.cn.