Labelling and Instructions for Use Language Rules in Morocco
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Morocco’s language requirements for labelling and instructions for use are divided by user rather than by product category. Documentation, labelling, and instructions for use for devices intended for professional use may be provided in English, French, or Arabic. Devices intended for lay users (the public) must use French or Arabic. Article 5 sets a floor requirement in addition: every device must be accompanied by instructions for use or a label containing the information necessary for safe use and allowing the manufacturer to be identified. French is the working language of the competent authority and of Moroccan healthcare institutions, and GRZAN recommends French as the primary language.
The practical point that follows from this structure is that the language decision is downstream of a user determination. Before any translation is commissioned, the project team must decide, and record, whether the device’s intended users are professionals or lay users, because that single determination selects the language set and therefore the artwork, the translation budget, and the risk of reprints.
The floor requirement of Article 5 also deserves attention. A label that shows only a trademark, or only the local distributor’s name, fails the requirement that the manufacturer be identifiable. This is a low threshold, yet it is checked frequently, and it can be cleared at the artwork stage at negligible cost.
2. Legal basis
| Instrument | Reference / number | Publication date | Provisions |
|---|---|---|---|
| Medical Devices Law (Loi n° 84-12) | Dahir n° 1-13-90 | 30 August 2013 | Article 5, second paragraph (instructions for use and labelling); Article 1, item 6 (intended purpose determined by labelling, instructions for use, and promotional material) |
| Pharmacy and Medicines Code (Loi n° 17-04) | Dahir n° 1-06-151 | 22 November 2006 | Articles 107 and 112 (restrictions on distribution channels, not directly related to language) |
Practical estimate: the language split between professional-use and lay-user devices comes from the consistent position of several international registration agencies and from AMMPS practice. The text of Law No. 84-12 does not directly regulate language, so this item is labelled a practical estimate.
3. Expert insights
Insight one: the statute does not name languages; the language requirements live in the checklist and in practice. The second paragraph of Article 5 only requires that every device be accompanied by instructions for use or a label containing the information necessary for safe use and allowing the manufacturer to be identified. The language split has formed in the order, the checklist, and the practice of the competent authority. The lesson for companies is that language questions cannot be answered by reading the statute alone; they must also check the current checklist and the hands-on experience of the licensed establishment.
Insight two: the dividing line is the user, not the sales channel. Products whose end users are individuals, such as blood glucose meters, home blood pressure monitors, and contact lens care solutions, can be treated as intended for the public even when they are sold through professional channels. The determination should rest on the intended user, not on who buys the product. A sales-driven reading of the rule is the most common analytical error on this topic.
Insight three: Article 1, item 6 turns labelling and instructions into legal evidence. The provision defines the intended purpose by reference to the use for which the device is destined according to the labelling, the instructions for use, or the promotional material given by the manufacturer. Where these three sources state the intended purpose differently, the device may be treated as having different intended purposes, which affects classification and the dossier. Terminology drift during translation is a real risk, not a stylistic concern.
Insight four: the weight of Arabic on the public-facing side is rising with policy. The official languages of Morocco are Arabic and French, and offering only English for public-facing products carries compliance risk. GRZAN recommends that public-facing products be offered at least in French, and in French and Arabic side by side where feasible. Professional-use products retain more latitude, but French remains the safest common denominator across both groups.
Insight five: wireless devices carry an additional labelling obligation. Devices with Wi-Fi or Bluetooth functions must obtain type approval from the national telecommunications regulator (ANRT), and the approval number must be marked on the label (see topic 30). Labelling for such products must satisfy AMMPS and ANRT requirements simultaneously, which means the artwork process needs two inputs rather than one and a reserve field for the approval number.
4. Practical recommendations
- Determine the intended user first, then fix the language. State the user type in the classification rationale at the same time, so the language decision has a documented basis that survives review questions.
- Use French as the primary language. French satisfies the requirement for both professional-use and public-facing devices and is the working language of the competent authority, which makes it the lowest-friction choice across the portfolio.
- Avoid English-only labelling for public-facing products. Provide at least French, and preferably French and Arabic in parallel, to remove the compliance risk attached to English-only presentation.
- Unify terminology across labelling, instructions, and promotional material. Maintain a terminology cross-reference table and run a three-way consistency check after translation, since the intended purpose is defined by all three sources together.
- Reserve a field for the ANRT approval number on wireless product labels. Plan the artwork layout with the field in place before approval is granted, avoiding a reprint of the whole label run afterwards.
5. Verification checklist
- □ Intended user determined as professional or lay user for the product
- □ Language scheme fixed according to user type (English acceptable for professional use; French or Arabic for lay users)
- □ Every product accompanied by instructions for use or a label (Article 5, second paragraph)
- □ Label and instructions contain information allowing the manufacturer to be identified
- □ Intended purpose statements consistent across label, instructions, and promotional material
- □ ANRT approval number field reserved on wireless product labels
- □ Translation terminology table established and reviewed
GRZAN supports manufacturers with labelling and instructions for use compliance for the Moroccan market, including user-type determinations, French and Arabic translation coordination, terminology consistency reviews across labelling, instructions, and promotional material, and ANRT labelling field planning. For assistance with registration documentation and conformity files for Morocco, contact GRZAN at info@grzanglobal.com.
Regulatory information verified as of 30 October 2026
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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