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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 Zambia has a developing private and public health care system which provides diagnostic and curative medical services. The Zambian government is giving priority to the health sector with the goal to ensure equitable access to healthcare services for all Zambians, i.e. better availability of adequate infrastructure, medical equipment and essential drugs.

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

Summary
  • Provides information on product definition and their governing regulations;
  • Describes the information on import regulations, requirements of a local agent;
  • Precise information on documents required, process, fees, timelines for import permit application and submission modes (online/in person);
  • Details the regulations applicable on labeling; and
  • Explains the bidding/tender regulation set by Zambia government with minutes discussion with eligibility and qualification required for tenderer.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY & REGULATIONS 
    1. Functions
  3. DEFINITION
  4. CLASSIFICATION
  5. PRODUCT REGISTRATION
  6. IMPORT PERMIT 2
    1. Process
    2. Documents Required
    3. Submission/Delivery Mode
    4. Fee
    5. Timeline
    6. Validity
    7. Register of Permits
    8. Renewal
  7. LOCAL AGENT
  8. LABELING 4
  9. GOVERNMENT TENDERS
  10. CONCLUSION
  11. REFERENCES
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