Free AI tool · No signupFree Senegal medical device classification tool
Describe your device and get a preliminary ARP risk class, a clear explanation, official source links, and similar registered products where available.
Free · no loginStructured outputOfficial source linksRegistry evidence where available
Describe your device
Try an example
Tell us what the device does, who uses it, how it contacts the body, and whether it is powered, implantable, sterile, measuring, software, or an IVD.
Preliminary informational result — not an official regulatory decision.0 / 5,000
About this classifier
What the Senegal classifier checks
The classifier compares your product description with current ARP classification requirements. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
- How are medical devices classified in Senegal?
- ARP uses a risk-based framework. Possible classes include IVDs: Classe A — Faible risque individuel et en matière de santé publique, Classe B — Risque individuel modéré et/ou faible risque en matière de santé publique, Classe C — Risque individuel élevé et/ou modéré en matière de santé publique, Classe D — Risque individuel élevé et aussi en matière de santé publique; Medical devices: Classe A — Faible, Classe B — Faible-moyen, Classe C — Moyen-élevé, Classe D — Élevé. Senegal classifies in vitro diagnostic devices on a separate table: décret n° 2023-2419, art. 18, gives four classes with their own risk descriptions — A Faible risque individuel et en matière de santé publique, B Risque individuel modéré et/ou faible risque en matière de santé publique, C Risque individuel élevé et/ou modéré en matière de santé publique, D Risque individuel élevé et aussi en matière de santé publique — and arts. 19 to 25 carry the DMDIV rules (transfusion and transmissible agents in class D, blood grouping and typing, autotests, reagents and specimen receptacles in class A, default class B). National four-class risk axis: décret n° 2023-2419 du 27 décembre 2023, art. 3, classifies medical devices into four categories by level of risk — A Faible, B Faible-moyen, C Moyen-élevé, D Élevé — and arts. 4 to 17 carry the classification rules for non-invasive, invasive, active and surgical devices. It is the national leg of the IMDRF/WHO model adopted across the UEMOA member states (UEMOA Décision n° 03/2022/CM/UEMOA, annexe I-1), not a projection of the EU MDR classes. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.
- What information does the Senegal classifier use?
- Current official ARP classification requirements. Your result includes an explanation and links to the official sources used.
- Is the result an official ARP classification decision?
- No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.
Keep researching this market
More Senegal medical device resources
Continue with this market