AMMPS Registration, Bonded EPP Storage & Medical Distribution in Morocco
Supply Moroccan university hospitals, private clinics, and public tenders without incorporating a local subsidiary. MediUnit, powered by ULTIMED S.A.R.L. (Licensed Establishment Law 84-12, ICE 001534471000020), operates as statutory Importer of Record and distributor: AMMPS registration, ANRT radio type-approval, maritime clearance at Casablanca Port, and bonded EPP warehousing in Bouskoura.
Four Operational Pillars for the Moroccan Market
AMMPS regulatory compliance, ADII customs clearance, bonded EPP warehousing, and nationwide hospital supply.
1. Registrant of Record (AMMPS & ANRT)
Dossier submission and maintenance with AMMPS and ANRT radio type-approval. You retain 100% ownership of your regulatory dossiers and IP.
2. Bonded Warehousing (24-Month EPP)
Licensed private bonded warehouse (EPP) in Bouskoura. Full suspension of import duties (up to 30.3%) and VAT (20%) until domestic hospital sale.
3. Port Customs Clearance (PortNet / BADR)
Active PortNet and BADR EDI accounts. Import titrage, expedited maritime clearance at Casablanca Port, and bonded transit under customs seal.
4. Batch Traceability & BPDS Delivery
Full batch-level tracking, expiry controls, cold-chain (2°C–8°C), and ambient climate (15°C–25°C). Direct delivery to university hospitals, private clinics, and military hospitals.
Two Operating Models Tailored to Your Commercial Strategy
Separate regulatory ownership from commercial execution, or entrust us with your full hospital deployment in Morocco.
| Operational Criterion | Model A: Regulatory Proxy & Bonded 3PL (Open Network) | Model B: Full-Service Turnkey Distribution |
|---|---|---|
| AMMPS Certificate Holder & Importer of Record | ULTIMED S.A.R.L. / MediUnit (Neutral regulatory proxy & Importer of Record) | ULTIMED S.A.R.L. / MediUnit (Exclusive or semi-exclusive importer & distributor) |
| Bonded EPP Storage (Art. 120 CDII - 24 Mo) | Included — ULTIMED Bouskoura Hub (Duty & VAT suspended) under ADII institutional bond | Included — Full safety stock management in Bouskoura hub under ULTIMED customs title |
| Sales Force & Commercial Promotion | Your appointed local distributors (multi-distributor setup without refiling AMMPS dossiers) | MediUnit commercial team (nationwide coverage: CHUs, private clinics, military hospitals) |
| Public Hospital Tenders (Decree 2-22-431) | Your distributors bid using formal Tender Authorization Letters issued by ULTIMED/MediUnit | MediUnit bids directly (marchespublics.gov.ma portal, bid/performance bonds, and clinical samples) |
| Cash Flow & Foreign Exchange (IGOC) | Ex-bonded warehouse D10 billing by ULTIMED to sub-distributors; EUR/USD forex repatriation after customs entry reconciliation | Direct firm purchase or bonded consignment; supplier settlement per statutory IGOC timelines |
| Client Protection & Confidentiality | Chinese Wall (Strict NDA): your pricing and end-customer portfolio remain strictly confidential | Detailed monthly sales reporting by batch, hospital facility, and geographical territory |
| Exit Clause (Local Subsidiary / Takeover) | Signing of AMMPS Relinquishment Deed within 15 business days (0 penalty fee) | Full transfer of regulatory certificates subject to agreed contractual notice period |
Operational Infrastructure on the Ground in Morocco
MediUnit handles maritime reception at Casablanca Port, climate-controlled EPP bonded warehousing in Bouskoura, and routine supply deliveries to hospital central pharmacies.
Bouskoura logistics hub (South Casablanca) with climate control (15°C–25°C), cold-chain (2°C–8°C), and 40’ HQ container accessibility.
Direct customs clearance at Morocco’s main commercial port handling over 80% of containerized medical imports.
Direct supply to central pharmacies: University hospitals (Ibn Sina, Ibn Rochd, Cheikh Khalifa, Cheikh Zaïd) and private clinics.
Surgical devices, sutures, implants, interventional instruments, urology, and sterile consumables.
Daily shipments with digitized waybills and verified signed proof-of-delivery (POD) records.
Contractual commitment to execute relinquishment letter within 15 business days upon your subsidiary obtaining its AMMPS license.
Moroccan Customs Duty & Working Capital Simulator
Under Articles 114 to 129 of the Moroccan Customs Code, MediUnit’s Entrepôt Privé Particulier (EPP) facility in Casablanca suspends customs duties and import VAT for up to 24 months. Taxes are payable only upon dispatch for domestic hospital delivery.
Upfront cash preserved with MediUnit EPP:
+84 990 MAD
Zero duty or VAT disbursed upon container discharge at Casablanca Port.
ADII Customs Bond Facility Included: MediUnit provides its global bank guarantee approved by the Customs Administration (ADII). You have no local credit line to freeze with a Moroccan bank.
Forex Repatriation & IGOC Protocol: Under consignment stock or sales releases, hospital dirham (MAD) receipts are converted and repatriated in foreign currency (EUR/USD) to the foreign manufacturer per Office des Changes (IGOC) instructions following customs clearance reconciliation.
Free Trade Agreements (EU & US FTAs): For EU (EUR.1 / REX) or US origins, import duty is 0%. Bonded EPP warehousing still delivers major cash savings by suspending the 20% import VAT across your entire safety stock for 24 months.
Forex Clearance & Currency Repatriation Architecture
How international manufacturers operate without tied-up capital and repatriate EUR/USD in full compliance with Moroccan Office des Changes regulations (IGOC):
Import Commitment
MediUnit creates the digital import commitment on PortNet under the private bonded warehouse (EPP) regime upon container discharge at Casablanca Port.
Bonded Consignment Stock
Cargo transfers under customs seal to our Bouskoura Hub. You retain inventory ownership while deferring 100% of customs duties and import VAT.
Fractional Clearance on Order
Upon hospital purchase orders, MediUnit settles duties/VAT only on the dispatched lot, delivers the facility, and collects MAD receivables.
EUR / USD Repatriation
Upon customs imputation on the PortNet title, net funds are converted and wired in foreign currency (EUR/USD) to your international corporate account.
Public Hospital Tenders & Procurement Compliance
Supplying Moroccan University Hospital Centers (CHUs) and Military Hospitals is governed by Public Procurement Decree No. 2-22-431. MediUnit directly bids or authorizes your local distributors:
marchespublics.gov.ma
Electronic submission of technical and financial bids with Barid Al Maghrib accredited digital signatures.
Provisional & Final Bonds
Issuance of local bank bid bonds and performance bonds required by Moroccan hospital procurement boards.
Sample Submissions & PV
Physical delivery of sterile technical samples to hospital evaluation committees with formal stamped deposit receipts.
Authorization Letter
MediUnit (as statutory AMMPS holder) issues formal Submission Authorization Letters to your designated local distributors.
Dossier Requirements by Risk Class & Wireless Track
Select your medical device risk class and hardware specifications to instantly generate the mandatory documentary submission pack required by AMMPS (formerly DMP) and ANRT per MDR/IVDR standards.
CE Certificate of Conformity (MDR 2017/745 / Annex IX or XI)
AMMPS TrackIssued by an EU Notified Body covering design and production quality management.
ISO 13485:2016 Quality Management Certificate
AMMPS TrackMandatory for foreign legal manufacturer and all active manufacturing/packaging sites.
Certificate of Free Sale (CFS / CLV) — Apostilled / Legalized
AMMPS TrackIssued by national competent authority (ANSM, BfArM, FDA, etc.) and apostilled for Morocco.
Bilingual Arabic & French Label Artwork (Law 84-12)
AMMPS TrackPack artwork compliant with Law 84-12 showing MediUnit as local licensed registrant.
Technical Datasheet & Instructions for Use (IFU)
AMMPS TrackDetailed technical specifications, clinical indications, and handling/reprocessing manuals.
Technical Performance & Lab Test Reports (EN / ASTM / ISO Standards)
AMMPS TrackAccredited testing verifying physical resistance, functional safety, and electrical conformity if applicable.
Clinical Evaluation Report (CER — MDR 2017/745 Annex XIV)
AMMPS TrackLiterature review, equivalence data, and clinical investigations proving favorable benefit-risk ratio.
ISO 10993 Biological Safety & Biocompatibility Evaluation
AMMPS TrackCytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility where applicable.
Post-Market Surveillance Plan & PMCF Protocol (MDR 2017/745)
AMMPS TrackProactive lifecycle monitoring procedures, vigilance alert matrix, and periodic safety update reports (PSUR).
ANRT Radiofrequency Type-Approval Dossier (BLE / Wi-Fi / 4G / RFID)
ANRT TrackParallel regulatory submission via PortNet/BADR with RED test reports, antenna gain, and frequencies.
Step-by-Step Deployment: What You Need to Anticipate
We decline unrealistic commitments. Here is the verified statutory schedule for Moroccan market access under Law 84-12 and how we accelerate each phase:
Technical Audit & Product Line Grouping
MDR/IVDR, ISO 13485 and apostilled CFS compliance audit. Strategic family bundling to optimize AMMPS filing fees and review rounds.
- ✓Your role: Provide CE certs (MDR/IVDR), ISO 13485, apostilled CFS, and technical documentation
- ✓ULTIMED / MediUnit action: Responsible Pharmacist audit, family grouping, and bilingual FR/AR labeling artworks (Law 84-12)
- ✓Deliverable: Target regulatory roadmap and Regulatory Hosting Agreement execution with irrevocable relinquishment undertaking
AMMPS Submission & ANRT Type-Approval
Physical dossier filing and digital submission to AMMPS in Rabat. Simultaneous PortNet lodgment for ANRT radiofrequency type-approval.
- ✓MediUnit / ULTIMED action: Statutory AMMPS filing in Rabat + PortNet tele-service lodgment for wireless devices
- ✓Deliverable: Official stamped AMMPS filing receipts securing priority date and queue standing
- ✓ANRT Approval: Radio type-approval certificates obtained in parallel within 4 to 8 weeks
Regulatory Review & Bonded EPP Hub Allocation
Proactive review monitoring with technical evaluation committees in Rabat, and operational readiness at Bouskoura bonded warehouse.
- ✓Observed timelines: 3–6 mo (Class I non-sterile), 12–16 mo (Class Is / IIa), 14–20 mo (Class IIb / IVD), 18–24 mo (Class III)
- ✓MediUnit action: Expert committee tracking, swift technical replies coordinated by Responsible Pharmacist
- ✓Logistical concurrency: ULTIMED PortNet account, Bouskoura bonded bay setup, and emergency ASI permits when urgent
Importation, Bonded EPP Storage & Hospital Release
Maritime clearance at Casablanca Port, bonded transit to Bouskoura without tax outlay, and fractional hospital release.
- ✓Bonded transfer under ADII seal to ULTIMED Bouskoura EPP (Art. 120 CDII): DUM D8 with zero upfront duty/VAT
- ✓Customary warehouse handling (Art. 124 CDII): bilingual in-bond labeling followed by fractional D10 releases on PO
- ✓Automated 5-year certificate renewal initiation at Month 36 preventing hospital delivery disruptions
Key Requirements of Moroccan Laws 84-12 & 10-22 for Foreign Manufacturers
Critical legal pillars of Moroccan medical device compliance managed directly by MediUnit:
Own-Account EPP & Importer of Record
Article 120 of the Customs Code limits EPP warehousing to goods imported for the holder’s own business. For foreign manufacturers, ULTIMED S.A.R.L. (ICE 001534471000020) legally acts as statutory Importer of Record on the Bill of Lading, PortNet license, and D8 entry, ensuring total customs compliance with zero third-party title risks.
Customary In-Bond Handling & Labeling
Article 124 authorizes customary handling in bonded warehouses: sorting, inspection, and affixing mandatory bilingual Arabic/French labeling under Article 35 of Law 84-12. These operations are conducted in our Bouskoura ISO 13485 facility prior to final domestic clearance (DUM D10).
Law J-90 vs Standard M-24
Decree 2-14-607 sets the statutory renewal deadline at least 90 days (J-90) prior to the 5-year expiry. MediUnit standard: We initiate renewal at Month 36 (M-24) to absorb committee review cycles with zero hospital disruption.
Mandatory Dual-Number System
The short number (e.g. 8102, 8240) appears on hospital quotes and invoices. The full legal registration number (e.g. 41028/2023/8102-2024/DM/DPS/DMP/18) is mandatory on customs DUM entries and public tender submissions.
Joint AMMPS & ANRT Filing
Any medical device featuring radiofrequency modules (Bluetooth, Wi-Fi, 4G, RFID) requires type-approval from ANRT via PortNet alongside the AMMPS sanitary technical registration dossier.
BPDS Compliance (Law 84-12)
In accordance with Articles 6 to 9 of Law 84-12, our establishment operates under a licensed Pharmacien Responsable registered with the CNOP, ensuring full compliance with Good Storage & Distribution Practices (BPDS).
MediUnit Operational Console Preview
Review real-time management of AMMPS certificates, bonded EPP inventory, and hospital deliveries.
| Device & Brand | Short ID (Invoicing) | Legal Reg No (DUM) | 5-Year Expiry | Renewal Trigger | Status |
|---|---|---|---|---|---|
Nitrile Examination Gloves (Powder-Free) MediShield Pro • Class I | #8102 | 41028/2023/8102-2024/DM/DPS/DMP/18 | 2029-03-15 | 2027-03-15 24 months before expiry | Active & Compliant |
Sterile Surgical Latex Gloves SurgiSafe Elite • Class IIa | #8240 | 42104/2022/8240-2023/DM/DPS/DMP/18 | 2028-06-20 | 2026-06-20 24 months before expiry | Month 36: Resubmission |
Natural Rubber Latex Male Condoms DermaProtect Care • Class IIb | #8390 | 43110/2022/8390-2023/DM/DPS/DMP/18 | 2028-09-01 | 2026-09-01 24 months before expiry | Month 36: Resubmission |
Single-Use Sterile 3-Part Luer Lock Syringes 5ml InfuTech Sterile • Class IIa | #8510 | 44550/2023/8510-2024/DM/DPS/DMP/18 | 2029-01-15 | 2027-01-15 24 months before expiry | Active & Compliant |
2-Way Silicone Foley Catheter CH16 UroFlow Pro • Class IIb | #8620 | 45670/2023/8620-2024/DM/DPS/DMP/18 | 2029-02-10 | 2027-02-10 24 months before expiry | Active & Compliant |
Request Regulatory & Customs Assessment
Our regulatory team evaluates your device risk classification (AMMPS/ANRT), applicable tariffs, and projected working capital savings under the Bouskoura EPP regime.
Frequently Asked Questions on Moroccan Market Access
Why does Article 120 of the Customs Code require ULTIMED to be the Importer of Record, and how do ULTIMED and MediUnit interact?
Article 120 of the Moroccan Customs Code stipulates that a Private Bonded Warehouse (EPP) is granted to a company for its own exclusive business: third-party Moroccan storage is strictly prohibited. As foreign manufacturers lack Moroccan corporate identity (no local ICE or Law 84-12 license), ULTIMED S.A.R.L. (ICE 001534471000020) legally serves as statutory Importer of Record on the Bill of Lading, PortNet license, and D8 entry. MediUnit powers the digital B2B marketplace, tender engine, and hospital storefront. This structure guarantees 100% customs compliance with zero regulatory risk.
Can mandatory bilingual Arabic/French labeling be performed inside the EPP bonded warehouse prior to customs clearance?
Yes, this is a cornerstone of our bonded access infrastructure. Article 124 of the Customs Code explicitly authorizes "customary warehouse handling". Supervised by our registered Pharmacien Responsable, our Bouskoura ISO 13485 facility applies mandatory bilingual Arabic/French labels and statutory markings under Article 35 of Law 84-12, along with secondary kitting, completely free of duty or VAT payment until subsequent domestic release.
Why appoint an independent Registrant of Record instead of a commercial distributor?
If your commercial distributor holds the AMMPS registration, you are commercially locked in: you cannot replace them or work with multiple partners without forfeiting your market authorization and restarting a 12–24 month review. MediUnit holds the certificates as a neutral regulatory proxy: you remain 100% free to appoint, replace, or expand your distributor network behind a strict contractual Chinese Wall.
How does EPP bonded warehousing and foreign currency repatriation work?
Cargo transfers from Casablanca Port to our Bouskoura EPP facility under customs seal, deferring import duty and VAT for up to 24 months. As hospital POs arrive, fractional clearance is executed lot by lot. MediUnit collects MAD receivables, clears taxes, and wires net proceeds in EUR/USD to your international bank via Moroccan banks approved by the Office des Changes upon PortNet customs imputation.
How does the transfer process work if we establish our own Moroccan subsidiary?
Our Regulatory Proxy Agreement guarantees an official Letter of Relinquishment (désistement) within 15 business days with zero financial penalty. As soon as your Moroccan subsidiary obtains its AMMPS Establishment License and appoints its licensed Pharmacien Responsable, MediUnit executes the transfer documents and hands over your complete technical dossier.
What are the specific requirements for connected medical devices (Wi-Fi, BLE, 4G)?
Connected devices require parallel processing: medical registration with AMMPS and radiofrequency type-approval with ANRT via PortNet (RED test reports, frequencies, radiated power). MediUnit manages both streams concurrently to prevent border customs impoundment at Casablanca Port.
How do we participate in public hospital tenders (CHUs & Military Hospitals)?
Public hospital tenders are governed by Decree 2-22-431 on marchespublics.gov.ma. Depending on the operating track, MediUnit can bid directly on your behalf providing local bank bonds and samples, or issue a formal Submission Authorization Letter to your local sub-distributors with the legal AMMPS certificate number.
Is there a legal bridge to import before the full 12–24 month AMMPS review concludes?
Yes. For life-saving devices or urgent hospital clinical needs, AMMPS can grant a Special Import Authorization (ASI) based on the official filing receipt and hospital medical justification. For standard devices, we employ strategic product family bundling to optimize fees and accelerate review.