Regulatory Report, In-Vitro Diagnostics, Nigeria, IVD Devices Registration

This report provides information on regulations imposed on In-Vitro Diagnostics (IVD) device in Nigeria as per Nigerian government for product import, registration process, classification, submission, renewal process & variation filing.
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.

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