IVDs on a Separate Track: Law 11-08 in Morocco

1. Key takeaways

In vitro diagnostic reagents (IVDs) in Morocco do not travel through Loi n° 84-12. They are governed independently by Loi n° 11-08 and its implementing decree, Décret n° 2-12-149 of April 25, 2012. The three most visible differences between the two tracks are these: IVDs have no risk classification; the statutory review period is up to 12 months (against 120 days for devices); and the registration and renewal fee, by consistent industry-sourced figures, is MAD 500 (against MAD 1,000 for devices). None of these differences is minor, and together they mean an IVD project cannot borrow the device project template. The longer review period shifts the entire critical path, the absence of classification changes how the dossier is organized, and the lower fee should not be mistaken for a lighter regulatory burden. GRZAN’s scheduling rule for IVDs is to plan launch on a 12 to 18 month backward calendar from the target market date, which is roughly twice the device timeline for a comparable product. Companies running mixed portfolios must split the two tracks at the very first planning meeting.

2. Legal basis

The IVD track rests on its own law and decree, while the device-side texts appear in the table only as the comparison baseline for the two differences that matter most in planning.

Practical estimate note: the 12-month IVD review period and the MAD 500 fee (MAD 1,000 for devices) are drawn from the consistent figures of multiple international registration agencies and industry sources. GRZAN has not located an independently numbered official Moroccan fee schedule for these figures, so they are marked as a practical estimate and must not be used as a quotation basis.

3. Expert insights

Insight 1: IVDs and devices are two parallel legislative systems. Article 20 of Loi n° 84-12 addresses the situation of a device presented together with a medicinal product, an in vitro diagnostic reagent or another product, and provides that each component remains subject to its own placing-on-market procedure. The clause is the strongest textual evidence that reagents sit outside the registration channel of the device law: if reagents were devices, no such carve-out would be needed. For portfolio companies, the takeaway is that Moroccan law deliberately built two doors, and the product profile — not habit or template reuse — decides which door each item takes.

Insight 2: The absence of risk classification produces uniform depth, not simplification. Devices can be tiered by class, with Class I files lighter than Class III files; IVDs have no such gradient, and every reagent follows the same procedure. Working information verified by GRZAN indicates that the local technical evaluation of IVDs may be heavier than for devices — several sources mention that an IVD may require an on-site clinical investigation — which is one explanation for the 12-month review period (this point is a practical estimate). Budgeting for an IVD should therefore assume the uniform, heavier file rather than a light one.

Insight 3: The review-period gap changes the scheduling logic outright. The difference between 120 days for devices and 12 months for IVDs means an IVD project cannot be run on a device schedule template. Where a company’s portfolio contains both devices and reagents, the two lines must carry separate timelines, separate fee assumptions and separate correction buffers, and commercial commitments for reagents must never be phrased in device tempo, because the statutory clock simply does not move at the same speed.

Insight 4: The authority transition applies equally to both tracks. After AMMPS took over, the IVD submission addressee and checklists can be re-versioned just as the device ones were, so the tracking mechanism should cover both tracks rather than only the device file (see the related article in this series).

4. Practical recommendations

1. Split the portfolio into devices and reagents first. Determine the track model by model at initiation, and run mixed portfolios as two separate project plans with separate milestones.
2. Plan IVDs backward from 12 to 18 months. Build the calendar from the statutory 12-month review period and add buffers for preparation and corrections on top of it.
3. Verify fees separately. Treat MAD 500 as a practical estimate and confirm the current fee text with AMMPS or the licensed establishment before fixing the official budget.
4. When a company holds both devices and reagents, maintain the certificates separately. Article 20 requires each component of a joint presentation to comply on its own; registration certificates are not interchangeable between tracks.

5. Verification checklist

• □ Each model has been determined to be a device or an in vitro diagnostic reagent
• □ It has been confirmed that IVDs are not subject to the classification of Article 4 of Loi n° 84-12
• □ The IVD project timeline is planned backward from the 12-month review period
• □ The current IVD fee has been checked with the licensed establishment (practical estimate: MAD 500)
• □ For jointly presented products, compliance documents have been prepared separately under Article 20
• □ It has been confirmed that the IVD submissions are addressed to AMMPS and the current checklist checked
• □ Separate ledgers and renewal reminders have been set up for the two certificate types

Regulatory information verified as of October 30, 2026. GRZAN supports IVD manufacturers entering Morocco under Loi n° 11-08 and Décret n° 2-12-149, including track determination, timeline planning and submission management before AMMPS. For project inquiries, contact info@grzanglobal.com.