Regulatory Report for Medical Device of Tanzania

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 Tanzania which offers realistic options for a viable business.

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

Summary
  • Provides information on product definition and their 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;
  • Describes the information on import regulations, requirements of a local agent; and
  • Explains the bidding/tender regulation set by Tanzanian government with minutes discussion with eligibility and qualification required for tenderer.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY AND GOVERNING REGULATION
  3. DEFINITION 1
  4. CLASSIFICATION 1
    1. General Classification Rules for IVDs
      1. Rule 1
      2. Rule 2
      3. Rule 3
      4. Rule 4
      5. Rule 5
      6. Rule 6
      7. Rule 7
  5. PRODUCT REGISTRATION 1, 2
    1. Process
    2. Documentation
    3. Submission Requirements for Class A IVDs
    4. Submission Requirements for Class B, C and D IVDs
    5. Submission Mode
    6. Registration Fees
    7. Timeline
    8. Validity
  6. IMPORT PERMIT 1
    1. Process.
    2. Release or Rejection of a Consignment
    3. Documents Required
    4. Renewal
    5. Importation of Unregistered In-Vitro Diagnostics 3
    6. Authorized Ports of Entry (PoE)
    7. Fee 2
    8. Timeline
  7. RENEWAL 1
    1. Fee and Timeline
  8. VARIATION 1
    1. Fee 3
  9. LOCAL AGENT REQUIREMENTS 1
    1. Qualification of Local Responsible Person
    2. Responsibilities of a Local Responsible Person
  10. LABELING 1
  11. TENDERS 
    1. Eligibility
    2. Qualification of Tenderer
    3. Medical Stores Department (MSD)
  12. CONCLUSION
  13. REFERENCES
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SKU:
FRE/IRMS/RI/MD-TZA/001
Price: 
$3,000.00