Regulatory Report for Medical Device of Namibia

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 Namibia. It represents one of the most diverse medical markets in the world largely because of the dominance of the South Africa.

The objective of this report is to provide precise information on the Regulatory landscape of Namibia, 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;
  • Precise information on health authority fees and validity;
  • Details the regulations applicable on labeling;
  • Describes the information on import regulations; and
  • Explains the bidding/tender regulation set by Namibia 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 and Timeline
    5. Validity
  6. IMPORT PERMIT
    1. Process.
    2. Documents Required
    3. Fee
    4. Timeline
    5. Validity
  7. LABELING
  8. GOVERNMENT TENDERS
    1. Procedure for Submission of Bids When Using Agent
    2. Qualification Requirements
    3. Bidding Documents
  9. CONCLUSION
  10. REFERENCES
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