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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 Ghana. Ghana is strategically positioned in Sub-Saharan Africa and is rapidly gaining prominence as an entry point for investors keen to work in the region. Its healthcare sector has strong growth prospects, fuelled by the expansion of a national health insurance scheme, a growing middle class and increased government spending.

The objective of this report is to provide precise information on the Regulatory landscape of Ghana, 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, timelines for registration and submission modes (online/in person);
  • Additional information on validity of the registration, renewal process and variation filing
  • Details the regulations applicable on labeling and language to be followed;
  • Describes the information on import regulations, requirements of a local agent; and
  • Explains the bidding/tender regulation set by Ghana government with minutes discussion with eligibility and qualification required for tenderer.
Table of Contents
  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

      1. Verification of Compliance to Current Good Manufacturing Practices (cGMP)
      2. Review of Application by Drug Registration Committee
    2. Types of Applications
      1. New Applications for Registration.
      2. Applications for Renewal of Registration
      3. Application for Variation of a Registered Medical Device
    3. Documents for Registration
    4. Dossier and Submission Format
      1. Data Presentation
      2. Language
    5. Submission/Delivery Mode
    6. Registration Fees
      1. Registration Fees

        1. Bank Payment Details
      2. Registration Timeline
    7. IMPORT PERMIT
      1. Process for Obtaining the Import Permit
      2. Documents
      3. Fee & Timeline
    8. PRODUCT REGISTRATION RENEWAL
    9. Documents Required
    10. Fee & Timeline
    11. LANGUAGE REGULATIONS
    12. LABELING
    13. TENDERS
    14. CONCLUSION
    15. REFERENCES
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