Field Safety Corrective Actions and Recalls: Withdrawal Procedures and Responsibility Allocation

1. Key takeaways

EDE may issue field safety notices for medical devices, and manufacturers must provide field safety notices of their own. Federal Decree-Law No. 38/2024 embeds the initiation and follow-up of field safety corrective actions (FSCA) along two lines: first, the obligations of the rights holder (Article 21), and second, the import and export permits and their revocation (Article 33); the emergency use authorization of Article 11 constitutes a fast track in special situations. Our judgment is that an FSCA in the UAE is not a purely commercial recall but a regulatory act tied directly to the status of the import permit; if the measures are not executed properly, the import permit may be revoked, and the consequence is far greater than the loss of a single batch of product. The triggering conditions, notification targets, bilingual communication and record retention must therefore be built into a plan that can be activated immediately, rather than assembled ad hoc after an event has occurred.

• FSCA is a regulatory act linked to import permit status, not an ordinary commercial recall.
• EDE field safety notices and manufacturer field safety notices are two separate documents with different issuers and audiences.
• Products under an Article 11 emergency use authorization follow a different decision path: report to EDE first, then decide on suspension of supply.
• Full FSCA records are archived to the GVP floor of 10 years, forming a complete evidence chain from signal to closure.

2. Legal basis

The table below sets out the GVP provisions on field safety notices and the three articles of the federal decree that give the FSCA mechanism its legal force.

3. Expert insights

Insight 1: The consequence of an FSCA falls on permit status, not only on product flows. Our professional judgment is that the revocation power of Article 33 should be understood as the source of enforcement power for the FSCA, with the authority able to use the import permit as an instrument of execution. The reason is that the import permit is the only channel through which a medical device may enter the UAE, and revocation is equivalent to withdrawal of the product from the market. On the trade-off, the FSCA plan should give priority to preserving the permit, that is, reporting proactively and presenting a proposal for measures before EDE intervenes, rather than waiting passively and letting the measures escalate.

Insight 2: The EDE field safety notice and the manufacturer field safety notice are two documents. The judgment is that a company cannot simply forward the EDE notice and consider the matter closed. The reason is that the GVP Guidelines require the manufacturer to issue its own field safety notice, and the two differ in both issuing party and audience. On the trade-off, bilingual English plus Arabic notice templates must be prepared in advance, fixed to include device identification, description of the problem, the action users should take, the action distributors should take and the deadline for feedback, so as to avoid consistency errors caused by ad hoc translation.

Insight 3: For products under the Article 11 emergency use authorization, the FSCA logic is different. The judgment is that such products are already used under restricted conditions; when a safety signal appears, EDE should be informed first before deciding whether to suspend supply, and the stop-sale step of an ordinary recall should not be applied directly. The reason is that the continuation of that authorization depends on the judgment of EDE, and a unilateral stop-sale may affect supply obligations under the authorization. On the trade-off, the plan should set out a separate disposal branch for products under the emergency use authorization.

4. Practical recommendations

• Prepare the FSCA plan in advance, stating the list of triggering conditions, decision authority, the list of notification targets and feedback deadlines, and designate a single external spokesperson.
• Keep the field safety notice template in both English and Arabic versions, with fixed fields for device identification, description of the problem, user action, distributor action and feedback deadline.
• Cover at least EDE, the responsible entity, all importers and distributors, and known user institutions among the notification targets, and record the delivery time and acknowledgment for each target.
• Set up a separate disposal branch for products under the Article 11 emergency use authorization: report first and decide afterwards, without directly applying the ordinary stop-sale process.
• Link recall execution with disposal approval: destruction or return of recalled products must be carried out only after the disposal approval has been obtained, and proof of disposal retained.
• Archive the full FSCA process records to the 10-year retention floor of the GVP Guidelines, forming a complete evidence chain from signal to closure.

5. Verification checklist

• □ The FSCA plan is in effect, containing the list of triggering conditions, decision authority and a single external spokesperson
• □ English and Arabic templates of the field safety notice have been prepared and reviewed by both legal and regulatory affairs
• □ The notification target list covers EDE, the responsible entity, importers, distributors and known user institutions
• □ A mechanism for recording delivery times and acknowledgments has been established and is traceable target by target
• □ A separate disposal branch has been set up for products under the Article 11 emergency use authorization
• □ Recalled product handling has been linked to the disposal approval under Articles 48-50
• □ Full FSCA process records are archived to meet the 10-year retention requirement

Further reading: Article No. 41, Pharmacovigilance System Obligations: Article 6(b), Article 21 and Article 23; Article No. 49, Safe Disposal and Destruction: Articles 48-50 and Disposal Approval; Article No. 33, The Article 22 Structure: 2 Importers + 1 Distributor + 1 Responsible Entity.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages adverse event reporting and recall coordination with MOHAP, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com