Botswana Medical Device Regulation

“BoMRA Medical Device Registration: Compliance Guidelines, Classification, and Latest Regulatory Updates in Botswana”

Updated on 23/01/24

Regulatory Authority: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:

Evaluation and Registration of Products: 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.

Licensing and Regulatory Compliance: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.

Pharmacovigilance and Clinical Trials:  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.

Establishment of BoMRA and Its Organizational Framework:  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.

Link for Regulatory Authority:https://www.bomra.co.bw/

Local Regulation:Guideline for Application for Registration of Medical Devices including In Vitro Diagnostics

Link for Regulation: https://bomra.co.bw/wp-admin/admin-ajax.php?juwpfisadmin=false&action=wpfd&task=file.download&wpfd_category_id=329&wpfd_file_id=24551&token=&preview=1

 Classification:

• For Medical Device: Class A, B, C, D
• For IVD: Class A, B, C, D

Registration Requirements:

• For Class A (non-surgical and non-measuring) Medical Devices including IVDs
  • Application Form
  • Agency Agreement
  • Reference Agency and Marketing history (if applicable) In cases where the manufacturer in not Botswana – Copy of product registration approval(s) from BoMRA recognised regulatory agencies and proof of marketing history in BoMRA recognised regulatory agencies
  • Declaration of Conformity
  • Certificate of Compliance with Recognized Standards
  • Manufacturer Name and Quality Management
  • Device Labelling
  • For Class A (surgical and measuring), Class B, Class C and Class D Medical Devices including IVDs
    • Application Form
    • Agency Agreement
    • Reference Agency and Marketing history (if applicable) In cases where the manufacturer in not Botswana – Copy of product registration approval(s) from BoMRA recognised regulatory agencies and proof of marketing history in BoMRA recognised regulatory agencies
    • Declaration of Conformity
    • Certificate of Compliance with Recognized Standards
    • Manufacturer Name and Quality Management
    • Summary Technical Documentation (STED)
    • System for post-marketing surveillance

Registration Timeline:

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.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]

https://bomra.co.bw/wp-admin/admin-ajax.php?juwpfisadmin=false&action=wpfd&task=file.download&wpfd_category_id=329&wpfd_file_id=24551&token=&preview=1