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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 Rwanda, which is a fast-growing economy with a rapidly expanding and increasing access to healthcare service.

The objective of this report is to provide precise information on the Regulatory landscape of Rwanda, 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 local agent requirements;
  • Precise information on import application documentation, fee, timeline and validity of import authorization;
  • Details the regulations applicable on labeling; and
  • Explains the bidding/tender regulation set by Rwanda government with minutes discussion with eligibility and qualification required for tenderer.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY & GOVERNING REGULATION
  3. DEFINITION 1
  4. CLASSIFICATION
  5. PRODUCT REGISTRATION
  6. IMPORT PERMIT
    1. Process
    2. Documents Required
      1. Import Visa
      2. Import License
    3. Temporary Import License
      1. Documents Required
    4. Fee
    5. Timeline
    6. Validity
  7. LOCAL AGENT REQUIREMENTS
  8. LABELING
  9. GOVERNMENT TENDERS
  10. CONCLUSION
  11. REFERENCES
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