Free Zambia medical device classification tool

What the Zambia classifier checks

How are medical devices classified in Zambia?

Zambia Medicines Regulatory Authority uses a risk-based framework. Possible classes include IVDs: Class A — low individual and low public-health risk, Class B — moderate individual and/or low public-health risk, Class C — high individual and/or moderate public-health risk, Class D — high individual and high public-health risk; Medical devices: Class A — lowest hazard, Class B, Class C, Class D — highest hazard. Zambia classifies IVDs on a parallel four-class system based on individual and public-health risk, published in the ZAMRA guideline for Grant of Marketing Authorisation of In-Vitro Diagnostic Devices for Human Use (ZAMRA/MA/GUD/0003): Class A low individual and low public-health risk, Class B moderate individual and/or low public-health risk, Class C high individual and/or moderate public-health risk, Class D high individual and high public-health risk. The IVD guideline excludes in-vitro diagnostics for veterinary use. Zambia's own four-class device axis, set out in the ZAMRA guideline Guidelines on the Principles of Medical Devices Classification (ZAMRA/MA/GUD/0002), which is an adaptation of the GHTF document GHTF/SG1/N77:2012 and structures the rules as 7.1 Non-Invasive Devices, 7.2 Invasive Devices, 7.3 Active Devices and 7.4 Additional Rules with Appendix A decision trees. The manufacturer determines the class; where more than one rule applies, or the device has multiple intended uses, it is allocated to the highest class indicated. Dossier depth follows the class: Class A files the shorter Annex II technical package, Classes B to D file the full Chapters 1-6 table of contents. 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 Zambia classifier use?

Current official Zambia Medicines Regulatory Authority classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Zambia Medicines Regulatory Authority 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.