Mandatory Medical Device Registration under Article 12 of Law No. 84-12

1. Key takeaways

Article 12, first paragraph, of Law No. 84-12 makes the placing of medical devices on the market conditional on the prior obtaining of a registration certificate issued by the competent authority, and the authority must seek the opinion of the National Advisory Committee for Medical Devices established under Article 36 before granting the certificate. The second paragraph restricts the recipients of the certificate to production sites or import sites that have been duly declared under Article 7. A registration certificate is valid for five years (Article 6 of Decree No. 2-14-607). The only exceptions are the six categories listed in Article 13, and every one of those categories still requires a specific authorisation.

In practical terms, no medical device may be lawfully marketed in Morocco until the Moroccan site that imports or produces it holds a valid registration certificate covering that product. Because the certificate attaches to the site rather than to the product, the number of certificates a portfolio requires depends directly on the distribution structure chosen for the market. The sanction regime in Article 44 confirms that operating without registration is treated as a serious infringement of the law and not as a mere paperwork gap.

2. Legal basis

3. Expert insights

Insight 1: Article 12 is a prohibition on the conduct itself, not a procedural formality. The rule directs that placing a device on the market is conditional on holding a registration certificate. The direct consequence of breach is set out in Article 44: for Class I and Class IIA devices, the fine is calculated at 5% to 7% of the turnover generated in Morocco excluding tax during the last complete fiscal year, with a floor of MAD 700,000; for Class IIB and Class III devices, the fine is calculated at 7% to 10% of that turnover, with a floor of MAD 1,000,000. Where users face a risk of death, the offender may be permanently banned from the activity. This is not a sanction regime that can be absorbed as a cost of doing business.

Insight 2: The Advisory Committee is a mandatory step and a time variable. Article 36 lists four advisory functions of the committee: registration applications; suspension or withdrawal of registration; withdrawal from the market for public health reasons; and applications for advertising visas and their withdrawal. The committee may also give its opinion on any other question arising in the field of medical devices. Notably, the market withdrawal procedure under Article 26 is likewise premised on the committee opinion, which shows that the committee is involved across the full lifecycle, from market entry through to market exit.

Insight 3: The exceptions are not exemptions; they are another approval track. The final paragraph of Article 13 provides that devices falling into the six exempt categories nevertheless remain subject to a specific authorisation issued by the competent authority under the prescribed conditions and procedures. The most common mistake made by companies is to read the exemption from registration as an exemption from formalities altogether. It is not: the substantive review is replaced, not removed.

Insight 4: One product, several importers, several certificates. Because the second paragraph of Article 12 directs the certificate to the site rather than to the product, the same device imported into Morocco by two different Moroccan importers will ordinarily require each importer to hold its own certificate. This directly affects channel design, the economics of multi-importer models, and the negotiation of exclusive distribution arrangements, since each additional importer means an additional dossier, additional fees and an additional maintenance line.

Taken together, the architecture of Article 12 can be summarised in three operating rules. First, market access runs through a Moroccan site: a foreign manufacturer reaches the market only through a production or import site declared under Article 7, and that site is the certificate holder of record. Second, market access runs through a product-by-product review: the committee opinion required under Article 36 is sought for registration applications, so each certificate reflects an individual assessment rather than a blanket approval of a catalogue. Third, market access runs on a five-year clock: the validity fixed by Article 6 of Decree No. 2-14-607 turns registration from a one-off project into a recurring maintenance obligation, and a lapse in renewal is treated exactly like an absence of registration.

4. Practical recommendations

1. Write first-certificate-then-sales into commercial contracts. Agreements with Moroccan distributors should state expressly that no quotations, tenders or deliveries may take place before the registration certificate is obtained. This aligns commercial behaviour with Article 12 and avoids pressure to ship early.
2. Count the certificates before designing the channel. A multi-importer model means multiple dossiers, multiple sets of fees and multiple maintenance lines. These costs should be estimated and budgeted before the channel structure is agreed, not discovered afterwards.
3. Reserve time for the committee opinion stage. The statutory 120-day review period in Article 4 of Decree No. 2-14-607 includes the committee deliberation. Schedules should not treat the review as a purely administrative step that runs on autopilot.
4. Maintain a certificate ledger. Record for each certificate its number, holder, device class, issue date and expiry date, and set renewal reminders at least 6 months before expiry so that continuity of market access is never put at risk.

5. Verification checklist

• □ It has been confirmed that the product requires a registration certificate before it is placed on the market
• □ It has been confirmed that the certificate is issued to Moroccan sites duly declared under Article 7
• □ It has been confirmed that the product does not fall within the six exceptions of Article 13 (and, if it does, a specific authorisation has been applied for)
• □ The five-year validity of the registration certificate has been recorded and a renewal reminder has been set
• □ The number of certificates required has been estimated according to the number of importers
• □ The sales contract includes a clause providing that no sales occur before the certificate is obtained
• □ The penalty tiers under Article 44 for placing unregistered devices on the market have been assessed

GRZAN support for the Moroccan market. GRZAN assists manufacturers and distributors with Morocco market entry, covering registration pathway selection, classification strategy, dossier preparation aligned with Law No. 84-12 and Decree No. 2-14-607, and coordination with the competent authority and licensed local sites. For guidance on the registration pathway and classification strategy best suited to your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026