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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 Uganda. Due to Uganda’s lack of medical infrastructure, it offers large influx of donor support for health programs, demand for medical equipment continues to rise.

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

Summary
  • Provides information on product definition and their governing regulations;
  • Carefully explains the information on IVD registration process;
  • Explains the registration process with flow chart;
  • Precise information on health authority fees, timelines for registration and submission modes (online/in person);
  • Additional information on validity of the registration and renewal process;
  • Details the regulations applicable on labeling;
  • Describes the information on import regulations; and
  • Explains the bidding/tender regulation set by Uganda government with minutes discussion with eligibility and qualification required for tenderer.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY
  3. DEFINITION
    1. Categorization of the Product Groupings
  4. GOVERNING REGULATIONS
  5. PRODUCT REGISTRATION 2
    1. Documents Required
    2. Submission Mode
    3. Process.
    4. Registration Fees
    5. Timeline
    6. Validity
    7. Registration Renewal
  6. IMPORT PERMIT 3
    1. Documents Required
    2. Process
    3. Timeline
    4. Fee
    5. Temporary Import License
    6. Import Permit Validity and Renewal
  7. RENEWAL FOR REGISTRATION 2
  8. LABELING
  9. TENDERS
    1. Selection of Bidders
    2. Basic Qualifications of Bidders
  10. CONCLUSION
  11. REFERENCES
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