Regulatory Report for Medical Device of Malawi

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 Malawi.

The objective of this report is to provide precise information on the Regulatory landscape of Malawi, 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, timeline, mode of submission and validity;
  • Details the regulations applicable on labeling;
  • Describes the information on import regulations;
  • Highlights the process for wholesale license and import permit with a flowchart; and
  • Explains the bidding/tender regulation set by Malawi 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. Wholesaler’s License
    2. Process and Requirements for the Import Permit
    3. Fee
    4. Timeline
  7. LABELING
  8. GOVERNMENT TENDERS
    1. Qualifications of a Tenderer
    2. Requirements of a Tenderer
  9. CONCLUSION
  10. REFERENCES
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