“BoMRA Medical Device Registration: Compliance Guidelines, Classification, and Latest Regulatory Updates in Botswana”
Botswana Medicines Regulatory Authority (BoMRA)
The Botswana Medicines Regulatory Authority, also known as BoMRA, is a corporate entity instituted under Section 3 of the Medicines and Related Substances Act (MRSA). Tasked with overseeing the safety, efficacy, and quality of various substances, BoMRA’s purview encompasses human and veterinary medicines, medical devices, and cosmetics within Botswana.
The Authority’s key functions are stated under Section 4 of the MRSA and include:
Guaranteeing the registration and adherence to quality, safety, and efficacy standards for all medicines and related substances produced within, imported to, or exported from Botswana.
Securing adherence to prescribed codes of practice and requirements for personnel, facilities, and procedures involved in the import, export, manufacturing, promotion, procurement, storage, distribution, and sale of medicines.
Oversight Overseeing the monitoring and reporting of adverse reactions to medicines, as well as conducting post-marketing surveillance to assess the quality, efficacy, and safety of medicines within circulation in Botswana.
The formation of the Medicines Regulatory Board, in accordance with Section 6 of the MRSA, is designed to oversee and regulate the management and financial aspects of the Authority. It is tasked with formulating policies, offering general or specific guidance to the Authority for the effective execution of its functions under the MRSA.
The Chief Executive Officer (“CEO”), appointed by the Minister of Health and Wellness based on the Board’s recommendation (as outlined in Section 5 of the MRSA), holds responsibility for the overall management, administration, and organization of the Authority, subject to the directives of the Board. The CEO is supported by senior officers appointed by the Board upon the CEO’s recommendation.
Additionally, the CEO has the authority to appoint officers and staff to aid in fulfilling the mandate of the Authority.
Guideline for Application for Registration of Medical Devices including In Vitro Diagnostics
Commencing on October 1, 2023, the Botswana Medicines Regulatory Authority (BoMRA) will launch a voluntary priority-based registration system for medical devices. By April 1, 2024, registration becomes obligatory for all medical devices, aligning with the priority medical devices list.
The stringent regulations stipulate that the importation of medical devices without BoMRA approval will be strictly prohibited, unless the devices are duly registered, listed, or exempted. These measures are firmly rooted in prioritizing patient safety and upholding the overall quality of medical devices integrated into Botswana’s healthcare system.
The phased implementation, starting with a voluntary system and transitioning to mandatory registration, underscores BoMRA’s commitment to a systematic and comprehensive approach in regulating medical devices. This strategic timeline allows for a smooth transition, ensuring that all stakeholders, including manufacturers, importers, and healthcare providers, can align with the regulatory requirements.
By fortifying the approval process and imposing restrictions on unregistered imports, BoMRA aims to enhance the safety and efficacy of medical devices, ultimately fostering a more robust and reliable healthcare infrastructure in Botswana.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.