Free Tunisia medical device classification tool

What the Tunisia classifier checks

How are medical devices classified in Tunisia?

Agence Nationale du Médicament et des Produits de Santé (ANMPS) uses a risk-based framework. Possible classes include Class I, Class Is, Class Im, Class IIa, Class IIb, Class III. Tunisia applies the European MDR risk-class taxonomy rather than a national class axis. The ANMPS device technical-dossier guide names Regulation (EU) 2017/745 as its normative reference and requires the manufacturer's declaration of conformity to state the device's risk class as I, Is, Im, IIa, IIb or III — the Is (sterile) and Im (measuring) sub-classes confirming that the taxonomy is adopted rather than paralleled. No Tunisian classification rules, guidance or decision tree separate from the EU regime was located, so the class is asserted by the manufacturer and verified by the ANMPS during the avis technique or the analyse. 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 Tunisia classifier use?

Current official Agence Nationale du Médicament et des Produits de Santé (ANMPS) classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Agence Nationale du Médicament et des Produits de Santé (ANMPS) 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.