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 Kenya. Kenya medical device market is expected to grow by a CAGR of 14.4% over the 2013-2018 period, alongside impressive GDP growth and strengthening imports.

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

Summary
  • Provides information on product definition and governing regulations;
  • Details the rules for classification of IVD;
  • Carefully explains the information on IVD registration process;
  • Highlights the documentation required for different classes of IVD;
  • Explains the registration process with flow chart;
  • Precise information on health authority fees for each class, 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, requirements of a local agent; and
  • Explains the bidding/tender regulation set by Kenyan government with minutes discussion with eligibility and qualification required for tenderer.
Tab title 2
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY
  3. DEFINITION
  4. CLASSIFICATION
    1. Classification Rules
  5. GOVERNING LAWS
  6. PRODUCT REGISTRATION
    1. Process for Product Registration
    2. Types of Application
    3. Documents for Registration
    4. Dossier and Submission Format
    5. Submission/Delivery Mode
    6. Registration Fees
    7. Registration Timeline
    8. Registration Validity
  7. IMPORT PERMIT
    1. Process for Import Permit
    2. Documents
    3. Fee & Timeline
  8. PRODUCT REGISTRATION RENEWAL
    1. Documents Required
    2. Renewal Fee & Timeline
  9. LABELING
  10. TENDERS 
  11. CONCLUSION
  12. REFERENCES
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