Morocco Medical Device Regulations

Morocco has a growing medical device market and is an important gateway to North Africa. Manufacturers seeking market access in Morocco must comply with local regulatory requirements and, in most cases, obtain medical device registration before commercialization.

Medical devices are regulated by the Moroccan Agency for Medicines and Health Products (AMMPS – Agence Marocaine du Médicament et des Produits de Santé).

The main regulatory framework is based on Law No. 84-12 relating to medical devices, together with its implementing decree and ministerial orders covering medical device registration, establishment requirements, classification, safety, performance and post-market obligations.

Medical devices in Morocco are currently regulated by AMMPS.

AMMPS is responsible for regulating health products, including medical devices, and manages activities related to product registration, establishment compliance, market surveillance, and post-market safety.

Older Moroccan regulations may still refer to the former Direction du Médicament et de la Pharmacie (DMP). These responsibilities have now been transferred to AMMPS.

The main legislation is Law No. 84-12 relating to medical devices.

Several implementing texts support this law, including:

• Decree No. 2-14-607
• Order No. 2853-15 – establishment declarations
• Order No. 2855-15 – medical device registration requirements
• Order No. 2856-15 – classification, essential requirements and good practices

Manufacturers should evaluate these requirements before submitting a medical device registration application.

Morocco uses a risk-based medical device classification system similar in principle to the European system.

Medical devices are divided into four main classes:

Class I devices can also include specific categories such as:

• Class Is: sterile devices
• Class Im: devices with a measuring function

Classification depends on factors including:

• intended purpose;
• duration of use;
• invasiveness;
• whether the device is active;
• anatomical location; and
• potential risk to the patient.

Correct classification is important because it determines which documentation and regulatory evidence must be provided during registration.

Medical devices generally need to obtain a Moroccan registration certificate before being placed on the market.

For imported medical devices, the registration certificate is normally held by a Moroccan importing establishment that has been properly declared to the competent authority.

This is different from the European Authorized Representative model.

A foreign manufacturer should therefore work with an appropriate Moroccan importer or local registration partner when preparing market entry.

The Moroccan importer must be properly established and declared for medical device activities.

Before starting product registration, manufacturers should verify that the importing establishment has the necessary regulatory status.

AMMPS has reinforced this requirement and requires a valid establishment declaration before issuing medical device registration certificates.

The device should be classified according to Moroccan classification rules.

The classification determines the level of documentation and supporting regulatory evidence required.

The registration dossier generally includes administrative and technical documentation relating to the device and manufacturer.

Depending on the device, documents may include:

• device information;
• manufacturer information;
• intended purpose;
• device classification;
• declaration of conformity;
• labeling;
• instructions for use;
• technical documentation;
• quality management system evidence;
• foreign market authorization; and
• clinical supporting evidence.

The exact documentation depends on the device classification and characteristics.

For imported Class Is, Im, IIa, IIb and III medical devices, Moroccan regulations require evidence demonstrating that the product has appropriate regulatory authorization in its country of origin or another recognized market.

Depending on the product, this may include:

• CE certification;
• FDA regulatory evidence;
• Certificate of Free Sale; or
• equivalent regulatory documentation.

Foreign authorization supports the Moroccan application but does not replace Moroccan registration.

For imported Class IIa, IIb and III medical devices, an ISO 13485 certificate or equivalent is required as part of the registration documentation.

Quality management system documentation should therefore be reviewed early in the registration process.

The completed registration dossier is submitted to AMMPS through the applicable regulatory submission process.

Morocco is progressively digitalizing health-product regulatory procedures through the TARKHISS platform, and manufacturers should confirm the current submission route when preparing a new application.

AMMPS evaluates the administrative and technical documentation.

Additional questions or documentation may be requested during the assessment.

For a complete dossier, the regulatory framework provides a decision within a maximum of approximately 120 days.

Actual project timelines may be longer depending on dossier readiness and regulatory questions.

A Moroccan medical device registration certificate is generally valid for five years and can be renewed.

Manufacturers and registration holders should also evaluate regulatory changes during the product lifecycle.

Changes affecting areas such as:

• manufacturer information;
• manufacturing site;
• product name;
• device references;
• labeling;
• instructions for use;
• storage conditions; or
• product composition

may require notification, modification of the existing registration or, in some cases, a new registration application.

Regulatory responsibilities continue after a medical device has been registered.

Manufacturers and local registration holders should maintain appropriate processes for:

• complaint handling;
• traceability;
• incident reporting;
• corrective actions;
• recalls; and
• matériovigilance.

Moroccan regulations require certain medical device incidents, risks of incidents, failures or quality problems to be reported to the competent authority.

Manufacturers should therefore establish clear communication procedures with their Moroccan importer so safety information can be managed efficiently.

CE marking can provide important supporting regulatory evidence when registering a medical device in Morocco. However, CE marking alone does not authorize a medical device to be placed on the Moroccan market.

Manufacturers must still complete the applicable Moroccan registration procedure and obtain the required registration certificate before commercialization.

In vitro diagnostic (IVD) medical devices are also subject to regulatory requirements in Morocco. The applicable registration pathway and documentation requirements depend on the device, its intended purpose, classification, and regulatory characteristics.

As part of the registration process, AMMPS evaluates the administrative and technical documentation and may request additional information or supporting evidence during its assessment.

For a complete dossier, the regulatory framework provides for a decision within a maximum of approximately 120 days. Actual timelines may vary depending on dossier readiness, the device, and questions raised during the regulatory review.

Entering the Moroccan market requires the right regulatory strategy from the beginning.

Easy Medical Device can support manufacturers with:

• Medical device classification
• Morocco regulatory strategy
• Importer and registration-holder requirements
• AMMPS registration support
• Technical documentation review
• ISO 13485 and QMS support
• Labeling and IFU review
• Registration renewal and change management
• Post-market regulatory support

Easy Medical Device can help you identify the applicable requirements, review your existing documentation and prepare a clear regulatory pathway for Morocco.

Contact our regulatory team to discuss your Morocco market-access project.