Establishment Declaration Before Opening and the 90-Day Rule

1. Key takeaways

Article 7 of Law No. 84-12 requires any establishment engaged in the manufacture, import, export, or distribution of medical devices to declare itself to the competent authority before commencing its activity, stating the nature of the intended activity and the devices concerned, supported by a dossier. Article 8 gives the authority 90 days from the date of submission to request additional information, inspect the premises, and issue observations; silence beyond that period is deemed acceptance. Article 9 requires that any change to the declared content be re-declared under the same conditions. Together these three articles form the gateway through which every Moroccan device business must pass before opening its doors.

2. Legal basis

3. Expert insights

Insight 1: Declaration is a pre-operation obligation, not retrospective filing. The temporal wording of Article 7 is “préalablement au commencement de son activité” — before the activity begins. Opening for business without declaring falls directly under the penalty regime of Article 43: for Class I and Class IIA devices, a fine of MAD 200,000 to MAD 500,000; for Class IIB and Class III devices, 2% to 5% of turnover with a floor of MAD 500,000. The stakes of sequencing are therefore not administrative but financial, and the fixed fines alone can exceed the entire annual cost of compliance for a small importer. Treating the declaration as a licensing formality to be completed later is a direct route into the penalty tables.

Insight 2: Deemed acceptance is a predictable starting point, but also a risk point. The 90-day design of Article 8 gives businesses a clear time expectation: once 90 days have passed after submission without objection, the declaration is deemed accepted. However, deemed acceptance does not mean the establishment has been formally approved and closed out. The competent authority retains the power to raise observations during the periodic inspections provided for under Article 38. Companies must therefore treat deemed acceptance as permission to start, not as the end of regulatory attention — documentation, premises, and declared activities must remain inspection-ready.

Insight 3: The four activity lines must each be declared. Article 7 lists four activities: manufacture, import, export, and distribution. An establishment that declared only distribution and then begins importing is operating beyond the scope of its declaration. GRZAN treats the match between declared scope and actual activity as one of three mandatory checks when auditing candidate certificate-holding establishments, alongside verification of the declaration receipt and review of the establishment’s regulatory track record. Scope mismatch discovered mid-shipment can leave goods stranded at customs while the establishment regularises its position.

Insight 4: The re-declaration obligation of Article 9 is frequently overlooked. Once any element that formed part of the original declaration changes — the establishment’s name, address, legal representative, warehousing conditions, or type of activity — the establishment must re-declare under the same conditions as the initial declaration. When a Chinese manufacturer changes partners but intends to keep using the same establishment, it must confirm whether any such changes have occurred and whether a re-declaration has been filed. An undisclosed change discovered later undermines the validity of the entire declaration chain, including any registration certificate issued on its basis.

Insight 5: Pharmacy dispensing is an exception. The final paragraph of Article 7 provides that the dispensing of devices by pharmacies does not require prior declaration, provided the devices concerned are registered under the Law or are authorised custom-made devices. This is an exemption aimed at pharmacies, not at general distributors. A distributor cannot rely on it to avoid its own declaration obligation, and the exemption does not extend to storage for wholesale distribution or import operations of any kind.

4. Practical recommendations

1. Complete the declaration before opening, not alongside operations. Treat the Article 7 declaration as the pre-operation gate for the establishment, and schedule it ahead of any first shipment or commercial activity.
2. Run the 90-day window in parallel with the product dossier. The establishment declaration review period and the product dossier preparation period can overlap, compressing the overall timeline to market.
3. Verify the match between declared scope and intended activity. Check the AMMPS register line by line against activity type and confirm that it covers the import activity required for the project.
4. Build a change-trigger list. Put name, address, legal representative, warehousing conditions, and activity type on a formal trigger list; any change starts a re-declaration under Article 9.
5. Retain the declaration receipt. The receipt is the key evidence of the submission date and the starting point of the 90-day period; keep it in the establishment’s compliance file.

5. Verification checklist

• □ The establishment has completed its declaration under Article 7 before commencing operations
• □ The declaration states the nature of the intended activity and the devices concerned
• □ The declaration dossier has been prepared in line with Arrêté n° 2853-15 and the current checklist
• □ The declaration receipt has been retained and the 90-day starting point is documented
• □ The declared business scope has been checked and covers import
• □ A change-trigger list under Article 9 has been established
• □ It has been confirmed that the pharmacy dispensing exemption does not apply to this establishment

Regulatory information verified as of 30 October 2026

GRZAN assists medical device manufacturers entering the Moroccan market with local establishment declarations, vetting of import and distribution partners, and full cost budgeting for registration and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.