Penalties, Fines, and Business Bans under Law 84-12

1. Key takeaways

The penalty regime of Law No. 84-12 is designed along two dimensions — nature of the conduct and device class — with three tiers: Article 42, MAD 60,000 to MAD 100,000 (failure to declare changes, breach of advertising rules); Article 43, MAD 200,000 to MAD 500,000 for Class I and Class IIA, and 2% to 5% of turnover for Class IIB and Class III (floor MAD 500,000); Article 44, 5% to 7% of turnover for Class I and Class IIA (floor MAD 700,000) and 7% to 10% of turnover for Class IIB and Class III (floor MAD 1,000,000). The courts may also impose a ban on engaging in device activities for 5 to 10 years.

2. Legal basis

3. Expert insights

Insight 1: The higher the class, the heavier the calculation method. Class I and Class IIA conduct is mostly punished with fixed ranges (MAD 200,000 to MAD 500,000), while Class IIB and Class III conduct is punished directly as a percentage of turnover excluding tax for the last completed financial year in Morocco. For larger companies, the absolute amount of a turnover percentage far exceeds the fixed range — this is how class differentiation expresses itself in the penalty tables. A company with substantial Moroccan revenue should therefore model percentage-based exposure for its high-class products as a governance matter, not merely as a legal footnote.

Insight 2: Article 44 targets the most serious conduct. The situations it lists include: placing on the market without registration; placing on the market or putting into service in breach of Articles 21 and 22; failing to report incidents or risks under Article 25; holding, placing on the market, selling, or operating devices that have been ordered withdrawn or destroyed; failing to take the recall and destruction measures under Article 29; and placing on the market used devices, evaluation samples, or exhibition samples. The threshold of this tier is public health risk, which is why its fines scale with turnover and why even a single serious breach can dominate a company’s risk profile in Morocco.

Insight 3: Article 45 closes the loophole of newly established companies without turnover. The provision states that establishments that have not completed their first financial year are subject to the minimum fine of Articles 43 and 44. A newly established company cannot escape penalty on the ground that it has no turnover. This matters for market-entry structures: setting up a fresh Moroccan entity does not reduce penalty exposure for the conduct of the entry phase, and the minimum fine applies at the floor amounts of the applicable tier.

Insight 4: The recidivism rule of Article 47 doubles penalties for the same nature of offence within 5 years. The provision states that committing an offence of the same nature within 5 years from the date on which the first judgment became final constitutes recidivism, and the penalties are doubled. For compliance management, this converts every resolved violation into a long-dated liability: the same failure recurring years later costs twice as much. It also makes documented, closed-loop remediation of each incident a direct financial protection.

Insight 5: The additional penalties of Article 48 are more damaging than the fines. The courts may order: confiscation of products and materials used or intended for use in the offence; a ban on the convicted person engaging in the manufacture, import, export, or distribution of devices for 5 to 10 years; and, where users face a risk of death, a permanent ban. For companies for which Morocco is an important revenue source, a business ban is a more severe consequence than any fine. It also reaches individuals, which raises the personal stakes of compliance failures for local management.

Insight 6: Article 46 is the residual clause. The provision states that offences other than those under Articles 41 to 45 of the Law are treated as offences under the Law on the repression of fraud in trade in goods, Law No. 13-83, and punished with the same penalties. This means Moroccan device offences are structurally anchored to a broader trade law, so even conduct outside the enumerated lists of Law No. 84-12 remains punishable through this residual route rather than falling into a gap.

4. Practical recommendations

1. Assess your penalty exposure by device class. Quantify the turnover-percentage exposure for Class IIB and Class III products and feed it into the risk assessment.
2. Turn the 48-hour reporting duty of Article 25 into a process. Failure to report incidents or risks falls directly under Article 44 and is a high-frequency risk point.
3. No placing on the market without registration is an absolute red line. Article 44 lists it first, and Class IIB and III conduct is punished at 7% to 10% of turnover.
4. Newly established entities also face the minimum fines. Do not assume that absence of turnover exempts you; Article 45 has closed that route.
5. Maintain a violations ledger with closed-loop remediation. The 5-year recidivism window of Article 47 requires long-term records; the same problem must never recur.

5. Verification checklist

• □ The applicable tier of Articles 43 and 44 has been assessed by product class
• □ The turnover-percentage exposure for Class IIB and Class III has been quantified
• □ The 48-hour reporting process of Article 25 has been established
• □ The red line of no placing on the market without registration is embedded in internal processes
• □ Newly established entities have been confirmed as subject to the minimum fines of Article 45
• □ A violations ledger and closed-loop remediation are in place (covering the 5-year recidivism window)
• □ The combined risk of Article 48 business bans and the residual clause of Article 46 has been assessed

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with penalty exposure assessment, vigilance and recall process design, and cost budgeting for registration and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.