Regulatory Report for Medical Device of Botswana

Why you should buy this report

This report is a single point solution to study end-to-end regulations imposed on In-vitro Diagnostic Device (IVD) in Botswana which is an emerging market. The government also seeks to improve health care infrastructure and provide and upgrade medical and surgical equipment, including improvements to several district medical facilities. The Ministry also plans the implementation of new performance standards, indicators, procedures and guidelines for the effective delivery of health care services.

The objective of this report is to provide precise information on the Regulatory landscape of Botswana, so as to enable a Regulatory go-to-market strategy and ensure compliance.

Summary
  • Provides information on product definition and governing regulations;
  • Precise information on product registration;
  • Describes the information on import regulations and highlights the process for import permit with a flowchart;
  • Precise information on import application fee and timeline of import authorization;
  • Details the regulations applicable on labeling; and
  • Explains the bidding/tender regulation set by Botswana government with minutes discussion with eligibility and qualification required for tenderer.
Table of Content
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY & GOVERNING REGULATION
  3. DEFINITION
  4. CLASSIFICATION
  5. PRODUCT REGISTRATION
  6. IMPORT PERMIT
    1. Process.
    2. Fee and Timeline
  7. LABELING
  8. GOVERNMENT TENDERS
    1. Eligibility for Tenderers
    2. Requirements of Tenderers
  9. CONCLUSION
  10. REFERENCES
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