Regulatory Report for Medical Device of Democratic Republic of Congo

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 DR Congo which offers realistic options for a viable business.

The objective of this report is to provide precise information on the Regulatory landscape of DR Congo, 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, requirements of a local agent;
  • Precise information on import application fees, timelines and renewal of import authorization;
  • Details the regulations applicable on labeling; and
  • Explains the bidding/tender regulation set by DR Congo 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
  6. IMPORT PERMIT
    1. Granting of the Import Authorization for IVDs
    2. Creation of Import Application File
    3. File Review by DPM
    4. Payment of Administrative Fees
    5. Granting of Import Permit
    6. Fee
    7. Timeline
  7. RENEWAL
  8. LABELING
  9. GOVERNMENT TENDERS 
  10. CONCLUSION
  11. REFERENCES
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SKU:
FRE/IRMS/RI/MD-COD/001
Price: 
$3,000.00