Free Bahrain medical device classification tool

What the Bahrain classifier checks

How are medical devices classified in Bahrain?

NHRA 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 I — Low Risk Medical Device, Class IIa — Low to Medium risk device, Class IIb — Medium to High Risk Device, Class III — High Risk Device. Bahrain classifies in-vitro diagnostic medical devices on a separate four-band axis published in the same section of the NHRA Medical Device Classification Guideline: 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, and class D high individual risk and high public health risk. IVD classes B, C and D must be registered; class A registration is optional (Registration Guideline Version 9.1, general rule 2). Bahrain classifies medical devices into four risk classes on the axis published in section 4 of the NHRA Medical Device Classification Guideline (Version 2.4, June 2022): class I low risk, class IIa low to medium risk, class IIb medium to high risk and class III high risk. The classification letter that fixes the class is a separate, fee-bearing NHRA service; the guideline states that the class is determined by the manufacturer and that where a device is not manufactured in the EU the applicant is referred to the EU classification rules (MDCG 2021-24). 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 Bahrain classifier use?

Current NHRA requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.

Is the result an official NHRA 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.