Used and Refurbished Devices: Decision No. 630-26 of March 2026

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Article 18 of Law No. 84-12 delegates to regulation the definition of the age, list, class and nature of second-hand and refurbished devices that may be registered. That delegation was first implemented systematically in March 2026 by Decision No. 630-26, which opens second-hand and refurbished registration for the medical imaging, external beam radiotherapy and brachytherapy equipment listed in paragraphs IIB and III of Article 4. The hard threshold is that, at the time of application, the device must have consumed no more than half of the total lifetime set by the manufacturer (for devices whose lifetime is measured in operating hours, the hours consumed must not exceed half of the rated maximum). The precondition is that the model has already been registered in Morocco as a new device, and that the quality, safety and performance standards and the intended use remain unchanged.

The regime is therefore a two-stage pathway with a calculable numerical gate and a closed list. Any second-hand programme must be built around both.

2. Legal basis

Legal instrumentReferencePublication dateProvisions
Law on Medical Devices (Loi n° 84-12)Dahir n° 1-13-9030 August 2013Article 18 (enabling provision); Article 4 (paragraphs IIB and III); Article 1, item 14 (definition of refurbished devices); Article 44 (penalties for unauthorised placing on the market)
Decision on registration of second-hand and refurbished medical devicesDécision n° 630-26March 2026 (signed by the Minister of Health and Social Protection and published in the official gazette; gazette issue number as published by AMMPS)List of equipment within scope (annex); remaining lifetime threshold; new-product registration requirement
Implementing decree of Law No. 84-12 (Décret n° 2-14-607)Décret n° 2-14-60718 September 2014Registration procedures complementing the decision

Practical estimate note: the content of Decision No. 630-26 (equipment list within scope, the half-lifetime threshold and the new-product registration requirement) has been compiled by GRZAN from public information published through official Moroccan channels; no unique official gazette issue number was obtained. Before formal submission, companies should verify the text of the decision and its annexed list with AMMPS or the licensed site.

3. Expert insights

Insight 1: Article 18 is an enabling provision, and the enforceable numbers live in the decision. Article 18 itself consists of a single sentence: the age, list, class and nature of registrable second-hand and refurbished devices are set by regulation. This means the scope of access for second-hand devices can be widened or narrowed, and companies must rely on the text of the decision in force, never on last year list. This is precisely why GRZAN treats it as a differentiated lever for market entry planning.

Insight 2: The half-lifetime threshold is a calculable hard criterion. The threshold is expressed as consumed lifetime not exceeding half of total lifetime. Applying it requires the manufacturer to provide a clear definition of rated lifetime, whether in years or in operating hours, and requires the importer to provide verifiable evidence of consumption. For devices whose lifetime is measured in operating hours, service records and equipment logs become the key evidence.

Insight 3: The new-product registration requirement creates a two-stage pathway. The decision requires that every device has already been registered in Morocco as a new device. Second-hand business therefore cannot exist independently: it attaches to the new-product registration of the model. A manufacturer seeking to run a second-hand imaging programme must first complete the new-product registration, and only then proceed to unit-by-unit registration of second-hand devices.

Insight 4: Categories outside the list are expressly excluded. Information verified by GRZAN shows that second-hand dental chairs, dental treatment units, air compressors and sterilisers are not on the open list and cannot be imported. A list-based regime operates on the principle that what is not listed is prohibited; companies cannot argue that what the law does not forbid is permitted.

Insight 5: Article 13, item 3, forms a separate and distinct channel. What Article 13, item 3, exempts from registration are used devices imported for the purpose of refurbishment and export; Article 18 and Decision No. 630-26 govern devices refurbished and placed on the Moroccan local market. One channel is for export, the other for domestic sales, and the compliance paths are entirely different. The two must not be conflated.

4. Practical recommendations

  1. Confirm the model is on the list before starting. Compare each model against the annexed equipment list of Decision No. 630-26, and do not launch programmes for unlisted categories.
  2. Schedule in two stages. New-product registration first, unit-by-unit second-hand registration second, with the two project plans managed separately.
  3. Prepare verifiable lifetime evidence. Obtain from the original manufacturer a rated lifetime statement, in years or operating hours, and assemble documentary proof of consumed lifetime.
  4. Confirm unchanged intended use and performance in writing. Provide a statement that the refurbished device still meets the original quality, safety and performance standards and that the intended use is unchanged.
  5. Overlay the Article 19 check. Imaging and radiotherapy devices are largely ionising radiation devices, so the radiation protection precondition applies equally.

5. Verification checklist

  • □ The original text of Decision No. 630-26 and its annexed equipment list have been obtained
  • □ The target model has been confirmed as included in the annexed list
  • □ The model has been confirmed as already registered in Morocco as a new device
  • □ A manufacturer rated lifetime statement, in years or operating hours, has been obtained
  • □ Evidence of consumed lifetime has been prepared and confirmed at or below 1/2 of rated lifetime
  • □ A statement that quality, safety and performance standards and intended use are unchanged has been prepared
  • □ The ionising radiation precondition of Article 19 has been checked
  • □ The refurbishment-for-export channel of Article 13, item 3, has been distinguished from the domestic sales channel

GRZAN support for the Moroccan market. GRZAN helps manufacturers assess whether their models fall within Decision No. 630-26, assemble lifetime and refurbishment evidence, and plan the two-stage registration pathway for second-hand and refurbished devices in Morocco. For support with registration pathways and classification strategy, 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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GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

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