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It 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 humans or animals.
Applicants are strongly encouraged to familiarize themselves with the criteria and requirements for review processes outlined in this guidance and the other relevant guidance documents before submitting their applications.
Once the scope has been defined, there are three discrete stages in performing a clinical evaluation:
Identification of pertinent standards and clinical data
Appraisal of each individual data set, in terms of its relevance, applicability, quality and clinical significance.
Analysis of the individual data sets, evaluation of the performance, safety, and presentational aspects of the medical device are reached.
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 Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.
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 Covid19 Updates