Medical Exemptions

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the BoMRA before they can be placed on the market in Botswana.

Classification of Medical Devices

Classification of Medical Devices:
a) Class A – Low Risk
b) Class B – Low-Moderate Risk
c) Class C – Moderate-High Risk
d) Class D – High Risk



Certificate of analysis from an accredited laboratory as per applicable national or International standards.



Certificate of analysis from an accredited laboratory as per applicable national or International standards



Provide certificates against standards like ASTM E1965-1998, EN12470-5:2003, IEC 62942-1 TS, ASTM E 1256 – 95, EMC reports or equivalent.


Medical Gown

Certificate of analysis from an accredited laboratory as per applicable national or International standards



Declaration of conformity (for Local Manufacturer only), and Clinical Evaluation and/or Validation report.

Registration of Medical Devices

Application Form for Exemption from Registration of Medical Devices, BOMRA/ER/MED/P01/F01, shall be used

Proof of payment of application fee BWP 350 (Non-refundable).

A copy of a manufacturing license and/or ISO 13485 certificate or Business license or any proof of manufacturer’s registration in the respective authorities .

A copy or proof of the Marketing Authorization and/or Free Sale Certificate issued by the relevant SRA or Singapore Health Sciences Authority or China National Medical Products (Only for Class A & B medical devices) Administration or South African Health Products Regulatory Authority (Only for Class A & B medical devices) and/or

CE certificate issued by European notified bodies (As per Medical Device Directive 92/42/EEC or In-Vitro Diagnostics Medical Device Directive 98/79/EC or Medical Devices Regulation (EU) 2017/745 or In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 ) for a product marketed in the European member states can be used as evidence for a marketing authorization in an SRA, and/or

In the case of WHO Prequalification-accepted products, a copy of a final acceptance letter. For Rapid Covid-19 antigen test kit WHO Emergency Use Listing is required

Clear Pictures/Photographs of a sample with manufacturer’s instruction for use of the device.

For specific products, see Download File.

All documents must be in English. If any document is not written in English, a verified translation to English should be provided along with the original.

If an application is found to be incomplete, the applicant would be required to provide the requested information within 48 hours after the receipt of the communication.

For medical devices and IVDs manufactured in Botswana, clauses 4.4 – 4.6 do not apply. For exemption from registration of these products the manufacturer is required to submit declaration of conformity, provide validation report from an accredited laboratory, relevant standards, or proof of conforming to the relevant standards and compliance to the WHO specifications as per the below link:

Priority medical devices list for the COVID-19 response and associated technical specifications (who.int)

Have a medical device?

Do you have any medical device that you would wish to register, its easy to do. Register your medical device now with BoMRA.