Donated Medical Devices: 30-Day Pre-Notification and the 25 Percent Rule

1. Key takeaways

Outside disaster situations, medical devices donated from abroad are not subject to the registration obligation of Article 12 or the exceptions of Article 13. Instead, the recipient must pre-notify the competent authority 30 days before the donation is shipped, and the authority may, within that period, oppose the entry of the devices by a reasoned decision. Donated devices must simultaneously satisfy four conditions: they must be manufactured according to standards equivalent to the standards currently in force in Morocco; they must already be commercialised in the country of origin; their remaining validity, where applicable, must be no less than one quarter of their total validity period; and their packaging must indicate the date of manufacture and the batch number and, where applicable, the expiry date. The beneficiaries are limited to state-owned healthcare institutions, local collectivités, the Moroccan Red Crescent, and non-profit recognised associations active in the health field.

The scheme therefore replaces product registration with a window-based control exercised by the authority over the recipient. Every element of a donation programme, from manufacturing documentation to shipping dates, must be organised around these four conditions and the 30-day notification window.

The design of the scheme explains why donations bypass registration. A donation is not a commercial placing on the market: it passes to a closed list of public-interest beneficiaries and cannot re-enter trade channels, so the legislator substitutes a window-based control by the authority for the product-by-product certificate of Article 12. What the authority verifies in that window is precisely what the four conditions guarantee, namely the standard of manufacture, the commercialisation history, the remaining validity and the integrity of the packaging. Because all four are factual matters, the notification file is built from documents rather than from argument, and the quality of those documents determines whether the 30 days pass without opposition.

2. Legal basis

3. Expert insights

Insight 1: The obligation to pre-notify rests with the recipient, not the donor. The provision states expressly that the pre-notification is made to the competent authority by the recipient. When a company acts as donor, it is easy to assume that the formalities sit on its own side; in fact, the Moroccan recipient institution must complete the notification 30 days before shipment. Contracts and logistics must therefore be scheduled backwards from that point.

Insight 2: The 30 days are an opposition window for the authority, not an approval period. The wording provides that within this period the competent authority may, by a reasoned decision, oppose the entry of such devices into the national territory. This is a silence-approves design, structurally identical to the 90-day tacit acceptance of site declarations under Article 8. Companies should retain the complete pre-notification receipt before shipment as proof that the 30-day period expired without opposition.

Insight 3: The 25% remaining validity is a hard threshold. The statutory wording requires a remaining validity, where it exists, greater than or equal to one quarter of the total validity period (supérieure ou égale au quart de leur durée de validité totale). This 1/4 threshold targets consumables and reagents carrying an expiry date; for such products, near-expiry donations are blocked outright and cannot be rescued by goodwill or urgency. In practice, the threshold means that the validity calculation must be done at the level of each batch and each expiry date, not at the level of the donation as a whole, and that the calculation table itself belongs in the notification file so the authority can re-check it.

Insight 4: The list of beneficiaries is closed. The provision limits beneficiaries to four classes: healthcare institutions owned by the State, local collectivités, the Moroccan Red Crescent, and non-profit recognised associations active in the health field. Donated devices therefore cannot enter commercial distribution channels, and cannot be donated to private for-profit institutions, however charitable the intent.

Insight 5: The authority retains the power to inspect at any time. The final paragraph empowers the competent authority to carry out any inspection at any time regarding the quality and the destination of donated devices. Both donor and recipient must therefore maintain complete and traceable records for as long as the devices remain in circulation. For the donor, this argues for shipping lists, batch records and transport documents that mirror what the recipient files with the authority; for the recipient, it argues for storage and distribution records that can reconstruct, device by device and batch by batch, where each donated unit went. Where the two sides maintain mirror records, an inspection becomes a routine document check instead of a dispute over facts that neither party can substantiate.

4. Practical recommendations

1. Plan backwards 30 days from shipment. Agree with the recipient institution on the person handling the pre-notification and the submission date, and reserve time for preparing the documentation.
2. Self-check the four conditions before donating. Prepare the statement of equivalence with current Moroccan standards, proof of commercialisation in the country of origin, a validity calculation table and photographs of the packaging markings, all at once.
3. Screen against the 1/4 validity threshold. For consumables and reagents, calculate the remaining validity ratio batch by batch before shipment, and do not load any batch that fails the threshold.
4. Confirm the eligibility of the recipient. Verify that the recipient belongs to one of the four classes listed in the provision, so that the donation is not refused or subsequently challenged.
5. Fix the donation file. Beyond the four condition materials, attach documentation stating the name and address of the donor, the identity of the beneficiary, and the name and address of the person supervising the donation operation.

5. Verification checklist

• □ It has been confirmed that the donation does not fall within the disaster situation exclusion
• □ The recipient completed the pre-notification 30 days before shipment and obtained the receipt
• □ A statement that the devices are manufactured according to standards equivalent to current Moroccan standards has been prepared
• □ Proof of commercialisation in the country of origin has been prepared
• □ The remaining validity has been calculated batch by batch and confirmed at or above 1/4 of total validity
• □ Packaging indicates the date of manufacture, batch number and, where applicable, expiry date
• □ The beneficiary institution has been confirmed as one of the four classes listed in the provision
• □ Documentation of the donor, beneficiary and supervising person has been attached

GRZAN support for the Moroccan market. GRZAN assists donors and recipient institutions in structuring compliant donation programmes for Morocco, including pre-notification files, the four statutory conditions of Article 22 and validity screening. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026