LEARN ABOUT
Medical Devices
The Botswana Medicines Regulatory Authority (BoMRA) is responsible for regulating medical devices, including In vitro Diagnostics (IVDs), to ensure compliance with rigorous standards of safety, quality, and efficacy. BoMRA oversees the registration, licensing, and importation of medical devices to prioritize patient safety and maintain the quality standards of medical devices within Botswana’s healthcare system.
Definitions
Medical Device
means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings and animals for one or more of the specific purposes of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury
– investigation, replacement, modification, or support of the anatomy or of a physiological process
– supporting or sustaining life
– control of conception
– Cleaning, disinfection and sterilization of medical devices or
– providing information for medical purposes by means of in vitro examination of specimens derived from the human body and
which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Note: An accessory is considered to be a medical device where an accessory is intended specifically by its manufacturer to be used together with the ‘parent’ medical device to enable the medical device to achieve its intended purpose, it should be subject to the same procedures that apply to the medical device itself.
In Vitro Diagnostic Device
Or its acronym “IVD” means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimen derived from the human or animal; solely or principally to provide information for diagnostic, monitoring or compatibility purposes which includes but not limited to – reagents used for IVD purposes, calibrators, control chemicals, specimen receptacles, software and related instruments or apparatus or other articles and are used for the following test purposes; diagnosis; aid to diagnosis; screening; monitoring; predisposition; prognosis; prediction; determination of physiological status.
MEDICAL DEVICES CLASSIFICATIONS
Medical devices including IVDs are classified into one of four classes where Class A represents the lowest risk and Class D the highest. Some of the risk indicators used to create the Classification Rules: degree of invasiveness, duration of contact, body system affected, supporting or sustaining life etc. It is the intended use of a device that primarily determines its class. Classification must be consistent with the claims that appear on the manufacturer’s label and advertisement for the device.
Classification of Medical Devices
(a) Class A – low risk;
(b) Class B – low to moderate risk;
(c) Class C – moderate to high risk;
(d) Class D – high risk
Classification of In-vitro Diagnostics Medical Devices
(a) Class A – Low Individual Risk and Low Public Health Risk
(b) Class B – low public health risk or moderate individual risk;
(c) Class C – moderate public health risk, but high individual risk; and
(d) Class D – High Individual Risk and High Public Health Risk
Location of risk classification guideline: https://bomra.co.bw/downloads/#51-114-wpfd-adopted-guidelines-1657004433
Administration
BOMRA aims to strengthen the oversight of medical devices in Botswana, enhance patient safety, and maintain the quality standards of medical devices throughout their lifespan in the healthcare system.
Identification
Identification of pertinent standards and clinical data
Appraisal
Appraisal of each individual data set, in terms of its relevance, applicability, quality and clinical significance.
Analysis
Analysis of the individual data sets, evaluation of the performance, safety, and presentational aspects of the medical device are reached.
Evaluation
At the end of the clinical evaluation a report is prepared and combined with the relevant clinical data to form the clinical evidence for the medical device.
The registration of medical devices
Interested applicants can apply for medical device registration through following routes:
- Screening only/Notification (for Non-Sterile, Non-Measuring Class A, Veterinary medical device, General Laboratory equipment.)
- Abridged (for medical devices approved by any Reference Regulatory authority or WHO, following policy BoMRA/ER/MED/Policy 01)
- Full Assessment (for all other medical devices)
- WHO’s Collaborative Registration Pathway
Currently, a transitional arrangement allows the importation of medical devices through the listing or exemption from registration process. This arrangement aims to facilitate trade, ensure business continuity, and maintain access to medical devices. However, starting from 1st October 2023, BOMRA will initiate a voluntary priority-based registration system for medical devices. From 1st of April 2024, registration shall be mandatory for all medical devices (according to the priority medical devices list). Importation of medical devices without BoMRA approval, except for those that are registered, listed, or exempted, will be strictly prohibited. These regulations prioritize patient safety and ensure the quality of medical devices within Botswana’s healthcare system.
Priority List for Registration
- Medical Implants
- Heart
- Central Nervous System implants
- Includes Spine and Neuro Implants
- Condoms and their lubricants
- Pregnancy test kits
- WHO Prequalified IVDs
- Locally manufactured medical devices
Licensing of Medical Device Establishments
BoMRA will publish a Licensing Call-Up Plan to inform stakeholders about the licensing process for medical device establishments. This plan will outline the type and class of medical device establishments that will be prioritized and sequentially called up for licensing.
| Name | File |
|---|---|
| Act | Visit |
| Regulation | Visit |
| Registration of medical devices (Guideline) | Visit |
| Registration of medical devices (Form) | Visit |
| Exemption of medical devices (Guideline) | Visit |
| Exemption of medical devices (Form) | Visit |
| Listing of Medical Devices (Guideline) | Visit |
| Listing of Medical Devices (Form) | Visit |
| Listing of Medical Devices Establishments (Guideline) | Visit |
| Listing of Medical Devices Establishments (Form) | Visit |
| Fees | Visit |
Guidelines and Important Downloads
- Adopted Guidelines
- Exemption of Medical Devices
- Listing
- Registration, Screening, Query Response
