Free Botswana medical device classification tool

What the Botswana classifier checks

How are medical devices classified in Botswana?

Botswana Medicines Regulatory Authority uses a risk-based framework. Possible classes include IVDs: Class A — Low Individual Risk and Low Public Health Risk, Class B — Moderate Individual Risk and/or Low Public Health Risk, Class C — High Individual Risk and/or Moderate Public Health Risk, Class D — High Individual Risk and High Public Health Risk; Medical devices: Class A — Low Risk/Hazard, Class B — Low to Moderate Risk, Class C — Moderate Risk to high Risk, Class D — High Risk. Botswana classifies IVDs on a parallel four-class individual/public-health-risk axis set out in BoMRA's Guideline for IVD Medical Device Classification (BOMRA/ER/MED/P04/G06, Issue 1.0): Class A low individual risk and low public health risk, Class B moderate individual risk and/or low public health risk, Class C high individual risk and/or moderate public health risk, Class D high individual risk and high public health risk, with the guideline's examples running from a clinical chemistry analyser and specimen receptacle at Class A to HIV blood donor screening and HIV diagnostic kits at Class D. Where more than one rule applies, or a device has multiple intended uses placing it in more than one class, it is classified in the higher class. The four-class system in BoMRA's Guideline for Medical Devices Classification (BOMRA/ER/MED/P04/G05, Issue 1.0, effective 01-04-2023), which the guideline describes as assigning every medical device to one of four classes by applying the classification rules: Class A represents the lowest risk and Class D the highest. The rules are set out GHTF-style as 6.1 Non-Invasive Devices, 6.2 Invasive Devices, 6.3 Active Devices and further rules, each with illustrative examples; where two or more rules apply, the device falls into the higher class, and where a system and its components fall into different classes each is classified separately. 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 Botswana classifier use?

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

Is the result an official Botswana 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.