Regulatory Report for Medical Device of Senegal

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 Senegal. It has a potential offering for medical equipment marketing among other top sectors.

The objective of this report is to provide precise information on the Regulatory landscape of Senegal, 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 Senegal 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
  4. CLASSIFICATION
  5. PRODUCT REGISTRATION
    1. Process
    2. Documentation
    3. Submission Mode
    4. Registration Fees
    5. Timeline
    6. Validity
    7. Renewal
      1. Documentation
      2. Fee and Timeline
  6. IMPORT PERMIT
    1. Process.
    2. Documents Required
    3. Fee and Timeline
  7. LABELING
  8. GOVERNMENT TENDERS
    1. Eligibility for Tenderers
    2. Requirements of Tenderers
  9. CONCLUSION
  10. REFERENCES
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