Opening a medical devices assembly and sterilization business in Morocco is a strategic move due to the country’s growing healthcare infrastructure, competitive labor costs, and government incentives for industrialization. To start this type of business, you’ll need to secure proper regulatory approvals, comply with international quality standards, and set up a cleanroom facility with sterilization capabilities.

Below is a complete guide on how to start, register, and operate a medical devices assembly and sterilization business in Morocco.

Why Morocco?

Morocco is emerging as a hub for industrial manufacturing and medical exports due to:

Free Trade Agreements (FTAs) with the EU, USA, and other countries
Industrial acceleration plans (P2I)
Government incentives through the Moroccan Investment and Export Development Agency (AMDIE)

Step-by-Step Guide to Starting a Medical Devices Assembly & Sterilization Business

1. Market Research & Feasibility Study

Before investing:

Analyze local demand and export opportunities
Identify potential clients: hospitals, clinics, distributors
Study competitors and industry trends
Evaluate ROI and startup costs (approx. $500,000+ depending on scale)

2. Choose the Right Legal Structure

SARL (LLC) (Société à Responsabilité Limitée) – Best for small to medium businesses
SA (Société Anonyme) – Suitable for large-scale operations

3. Obtain Required Certifications and Licenses

To legally manufacture and sterilize medical devices in Morocco:

Get approval from the Ministry of Health and Social Protection
Ensure compliance with:
- ISO 13485 – Medical devices quality management systems
- ISO 11135 / ISO 11137 – Sterilization standards (Ethylene Oxide / Radiation)
- CE marking for exporting to the EU

💡 Pro Tip: Partner with a notified body or consultant to handle certification processes faster.

4. Find or Build an Industrial Facility

Look for industrial zones in Casablanca, Tangier, or Kenitra. Choose a site that supports:

Cleanroom construction (ISO Class 7 or better)
Sterilization unit (EtO, Gamma, or Steam)
Cold chain logistics (if needed)

5. Install Equipment and Hire Skilled Staff

Essential machinery and departments:

Assembly stations (manual or automated)
Cleanroom and HVAC systems
Sterilization chamber (Ethylene Oxide or Gamma irradiation)
Packaging and labeling units
Quality control & microbiology labs

Recruit:

Biomedical engineers
Quality Assurance (QA) & Regulatory Affairs experts
Trained technicians and operators

6. Implement a Quality Management System (QMS)

Create SOPs and documentation for:

Device traceability
Batch release and validation
Sterilization cycle monitoring
Recall procedures
Internal audits

A strong QMS is mandatory for ISO 13485 and global trust.

7. Register Products and Start Commercialization

Each medical device must be:

Registered and approved by the Moroccan Ministry of Health
Documented with technical files, labeling, and safety information

For exports, comply with importing countries’ regulations (FDA, EU MDR, etc.)

FAQs

1. Do I need ISO certification to start in Morocco?

Yes. For medical devices, ISO 13485 is required to ensure your quality system meets global standards.

2. What types of devices can I assemble and sterilize?

You can start with low-risk (Class I or IIa) devices like:

Syringes
Surgical masks
Catheters
Medical tubing
Wound care products

Then expand to Class IIb or III with more regulatory controls.

3. How long does the setup process take?

On average, 6 to 12 months, depending on:

Facility construction timeline
Regulatory approval speed
ISO certification process

4. Can I export sterilized devices from Morocco?

Yes. With the right certifications (CE, ISO 13485), Morocco is a strategic base to export to the EU, Africa, and MENA.

Final Thoughts

Starting a medical devices assembly and sterilization business in Morocco is a smart investment in a high-growth sector. With proper planning, ISO compliance, and regulatory approvals, you can build a globally competitive manufacturing hub in North Africa.

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