Safety Declaration and Appendix 6 Vigilance Obligations in Egypt

1. Key takeaways

At the registration stage, Egypt splits vigilance obligations into two lines with different audiences. The first line is submitting documents to the medical device safety department — it applies only to Class IIb or Class III devices, and to Class I and Class IIa devices subject to regulatory actions, and only in the situations of registration/re-registration of imported devices and re-registration of locally manufactured devices. The second line is the safety declaration issued by the manufacturer — it applies to registration and re-registration of imported devices of all classifications and to re-registration of locally manufactured devices, with the form set out in Annex 6. The coverage of the two lines differs, and companies routinely mistake the scope of the first line for the whole obligation — a Class I imported device with no regulatory actions need not go to the safety department, yet it still owes the safety declaration.

2. Legal basis

3. Expert insights

Insight 1: submitting to the safety department and issuing the safety declaration are two different thresholds, and the latter covers more ground.

Section 8 states that documents must be submitted to the medical device safety department only for Class IIb or Class III devices, and Class I or IIa devices with regulatory actions, limited to registration/re-registration of imported devices and re-registration of locally manufactured devices; the safety declaration, by contrast, must be provided by the manufacturer for registration or re-registration of imported devices of all classifications and for re-registration of locally manufactured devices. In other words, an imported Class I device without regulatory actions need not reach the safety department but must still carry the safety declaration.

Insight 2: the importing company’s vigilance commitment is a separate, third obligation.

Section 8 further provides that when applying for registration/re-registration, the importing company must submit an undertaking that it has established a device vigilance system and follows up on all its activities and requirements in conformity with the medical device vigilance system guideline, liaising with the medical device safety department — Egyptian Pharmacovigilance Center. The obligated party here is the importing company, not the manufacturer, so the two documents come from different entities.

Insight 3: the reporting duties for global recalls and domestic incidents are written into the commitment at registration.

Section 8 requires companies to report any recall, field safety notice (FSN) or field safety corrective action (FSCA) occurring globally, as well as any incident monitored within the Arab Republic of Egypt, to the medical device safety department — Egyptian Pharmacovigilance Center, within the timelines set by the medical device vigilance system guideline. This connects to the three tiers of 2 / 10 / 15 calendar days in GL.CAP.Care.040.

Insight 4: the declaration of compliance with safety procedures in Annex 1, item 3 and the safety declaration form in Annex 6 point to the same system at different levels.

Annex 1, item 3 requires a declaration of compliance with safety procedures issued under the circulars of the General Manager of the Egyptian Pharmacovigilance Center (approved April 24, 2018 and August 8, 2019); the closing of Section 8 lands on the safety declaration form (Annex 6). Together they constitute the vigilance document package at registration. (Practical estimate: the specific form number and current version follow the templates published on the EDA website.)

Insight 5: the safety department’s opinion can be the decisive factor for skipping the committee at re-registration.

Section 10 provides that for locally manufactured devices and devices imported from non-reference countries, re-registration does not require re-evaluation by the scientific committee where a report from the safety department states that the documents have been accepted, the device has not been subject to regulatory actions, and the registered device shows no change in composition — intended use — design — classification. This is a high-value design: a positive safety department opinion plus no change can spare Chinese manufacturers the committee stage at re-registration.

Insight 6: the safety department’s opinion can equally trigger a committee review.

Section 5 lists as the fifth category of cases presented to the committee: where the safety report issued by the medical device safety department recommends presentation to the scientific committee, or where its report’s assessment concludes that presentation is needed. The safety department is thus both the basis for exemption and the source of a requirement to appear.

Insight 7: the F-Toll route writes the same obligations into the contract.

Among the mandatory clauses of the F-Toll contract in Annex 3 are establishing a device vigilance system and following up all its activities and requirements, and reporting global recalls/FSN/FSCA and incidents monitored within Egypt. The content matches Section 8; only the carrier changes, from an undertaking letter to a contract that is notarized and reviewed by EDA legal affairs.

4. Practical recommendations

1. Keep the two lines separate: only Class IIb/III and Class I/IIa with regulatory actions go to the safety department; all classifications owe the safety declaration.
2. Have the manufacturer issue the safety declaration (Annex 6) during dossier assembly, not after a deficiency letter.
3. Issue the importing company’s undertaking separately: an established vigilance system liaising with the Egyptian Pharmacovigilance Center.
4. Build an SOP for reporting global recalls/FSN/FSCA: operate on the 2 / 10 / 15 calendar-day tiers.
5. Seek a positive safety department opinion before re-registration: combined with no change, it waives the committee stage.
6. Keep composition — intended use — design — classification unchanged during the licence life, or assess consequences before changing.
7. Write the vigilance clauses into F-Toll contracts and submit them for EDA legal review.

5. Verification checklist

• □ Determined whether the case falls within the scope requiring submission to the safety department (Class IIb/III; Class I/IIa with regulatory actions)
• □ Manufacturer’s safety declaration (Annex 6) issued, covering all classifications
• □ Importing company’s vigilance system undertaking issued
• □ SOP established for reporting global recalls/FSN/FSCA and domestic incidents
• □ Reporting timelines configured on the 2 / 10 / 15 calendar-day tiers
• □ Before re-registration: safety department opinion confirmed and no change in composition — intended use — design — classification
• □ F-Toll contract contains the vigilance clauses and has been submitted for review

Regulatory information verified as of October 29, 2026. The vigilance obligations at registration follow the current text of Section 8 and Annex 6 of EDREX: GL.CAMD.002 Version 2; reporting timelines follow EDREX: GL.CAP.Care.040 Version 1 (November 2025).

• Local resources in Egypt: GRZAN supports manufacturers from the Chinese mainland and overseas in dealing with the Egyptian Drug Authority (EDA) on medical device registration, import approval and change applications, including registration applicant scheme design (import company / local factory / scientific office), scientific committee evaluation preparation, reference-country free sale certificate route argumentation, Arabic labelling and IFU localization, and vigilance system and periodic reporting set-up.
• Service capabilities: product attribute and risk classification (device Class I–III / IVD Class A–D), registration and re-registration, system and bundled registration applicability, three-category change determination, import approval and the annual import plan, vigilance reports and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.