Why you should buy this report

This comprehensive report provides precise information on the regulations applicable to In-Vitro Diagnostic (IVD) devices in Nigeria, to enable a Regulatory go-to-market strategy and ensure compliance.

Summary

• Product definition and classification criteria;
• IVD registration process;
• Precise information on health authority fees, timelines for registration and submission mode (online/in person);
• Additional information on the validity of registration, renewal process and variation filing
• Regulations on labeling, claims and advertising;
• Information on import regulations and the requirement of a local agent; and
• Explains the bidding regulation set by the Nigerian government.

Table of Contents

1. LIST OF ABBREVIATIONS
2. GOVERNING BODY
3. DEFINITION AND CLASSIFICATION
   1. Classification
      1. Rule 1
      2. Rule 2
      3. Rule 3
      4. Rule 4
      5. Rule 5
      6. Rule 6
      7. Rule 7
4. GOVERNING REGULATIONS
5. PRODUCT REGISTRATION
   1. Type of Applications
   2. Documents Required
   3. Submission Mode
   4. Process
   5. Fee
   6. Timeline
   7. Validity
6. IMPORT PERMIT
   1. Documents Required
   2. Process
   3. Fee
   4. Release of the Consignment from the Port of Entry
   5. Timeline
7. RENEWAL
   1. Timeline
   2. Fee for Renewal
8. LOCAL AGENT REQUIREMENTS ³
   1. Qualification of Local Agent
   2. Responsibilities of a Local Agent
9. VARIATIONS
   1. Applications
   2. Documentation
   3. Fee
10. LABELLING ³
11. GOVERNMENT TENDERS
12. REFERENCES

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