Morocco Recall and Withdrawal Timelines Under Law 84-12

1. Key takeaways

Article 26 of Law No. 84-12 splits the withdrawal procedure into two timelines. In the ordinary case, the competent authority notifies the certificate holder and grants a statement period of not more than 15 days; after consulting the committee, it may then order immediate cessation of distribution and a recall. In urgent cases, the authority suspends the registration by a reasoned decision, orders preventive withdrawal within 15 days, and must issue its final decision within not more than 60 days from the date of suspension. Article 27 separately provides a channel for the certificate holder to apply voluntarily for permanent withdrawal from the market. For manufacturers, the practical reading is that the ordinary timeline is a procedural right to be defended, the urgent timeline is a suspension clock that cannot be left to run, and both converge on disposal obligations that must be documented under Article 29. Because the two timelines use different triggers — a risk assessment in the ordinary case, urgency in the other — the same defect can follow either path, and the company’s preparation should not assume which one will apply.

2. Legal basis

3. Expert insights

Insight 1: the 15-day statement period is a procedural right of the certificate holder. The provision requires the competent authority, where it considers that a device may present a risk to public health, to “immediately notify the certificate holder and invite it to submit its observations within a period not exceeding 15 days”. These 15 days are the only window in which the company can organize its technical defense; after that, silence is treated as no response and the procedure moves to the next step. Treat the notification date as day zero of a prepared response plan, because a defense assembled from scratch in two weeks rarely matches the quality of one drafted in advance.

Insight 2: the 60-day limit on urgent suspension is the time limit of a provisional state. The third paragraph provides that, in urgent cases, the authority suspends the registration and orders preventive withdrawal, and that the final decision must be taken within 60 days from the date of suspension, following the procedure of the second paragraph. This clause prevents the risk of “suspension becoming indefinite”, and it gives the company a date against which to plan both its defense and its commercial contingencies.

Insight 3: Article 29 places the disposal duty on the certificate holder. The holder must take all necessary measures to execute the recall and, within the period set by the competent authority, proceed to the destruction of the batches or their return to the exporter or transfer to another qualified party abroad for destruction or refurbishment, and provide the competent authority with documentary proof that these operations were completed. Disposal is not a matter of simply deleting stock records: every step must leave evidence. This includes the custody chain for recovered units, the identity of the destruction or refurbishment provider, and the dates on which each operation was completed.

Insight 4: Article 27 gives companies a voluntary exit channel. On the basis of a reasoned application, the certificate holder may ask the competent authority to withdraw the device from the market permanently; the authority executes the decision after assessing the reasons and the impact of the withdrawal on market supply. This is the compliant route for product-line adjustments — far safer than silently stopping sales of a registered device.

Insight 5: the cancellation grounds in Article 28 include “failure to achieve the intended effect” and “composition inconsistent with the declaration”. Read in context, the listed situations include: a device that cannot achieve its intended effect; a device that does not possess the qualitative or quantitative composition declared (without prejudice to the law repressing fraud in goods); and a device that has been ordered withdrawn from the market. The third ground points to judicial decisions as a trigger.

Insight 6: every withdrawal decision passes through the committee. Article 26 requires the competent authority to act after consulting the national advisory committee for medical devices established under Article 36. This closes the loop with Article 12 on registration — the same committee governs entry into and exit from the market, so committee practice is worth monitoring on both sides. For the company, it also means the reasoning recorded in committee deliberations on comparable cases can be a useful predictor of how a future withdrawal decision will be framed.

4. Practical recommendations

1. Treat the 15-day statement period as an emergency drill item. Prepare technical-defense templates and assign owners in advance, so the response starts on the very day the notification arrives.
2. Make the recall plan cover every channel. Design the recall workflow to meet Article 29: notification of distribution establishments, customer notification, recovery and disposal records. The plan should state who decides, who communicates and who assembles the disposal evidence before any event occurs.
3. Keep the disposal evidence chain complete. Retain proof at every step of destruction or return, and submit it within the period set by the competent authority.
4. Use Article 27 for voluntary withdrawals. When adjusting a product line, file a reasoned application instead of simply ceasing sales on your own initiative.
5. Agree a cooperation mechanism with the license-holding establishment. The obligations under Articles 26 to 29 rest mainly on the certificate holder; manufacturers should agree in the contract on information exchange and cost sharing.

5. Verification checklist

• □ The emergency workflow and owners for the 15-day statement period are defined
• □ The recall plan covers distribution establishments, customers and end users
• □ Evidence-chain templates for destruction or return are ready
• □ Disposal deadlines set by the competent authority are tracked
• □ The Article 27 voluntary withdrawal channel is built into the product-line adjustment process
• □ The cooperation mechanism between license holder and manufacturer is written into the agreement
• □ The role of the Article 36 committee in every withdrawal decision has been confirmed

Regulatory information verified as of October 30, 2026

Post-market support from GRZAN. GRZAN supports medical device manufacturers and importers in the Moroccan market across the full post-market compliance cycle, including recall and withdrawal execution, regulator notifications, disposal evidence management and responses to competent-authority correspondence. If you have received a notification, need to prepare a statement within a 15-day window, or want a recall plan tested before it is needed, contact info@grzanglobal.com.