Medical Devices Guidelines

This resource contains guidance and regulatory documents for manufacture, importation, distribution, sale and use of medical devices products in Nigeria.

Title	Product Type	Category	Status	Expiration Date
NAFDAC Laboratory Sampling Guide 2023	Regulated Products	Sampling Plan	Published
Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory Chemicals	Chemical	Import Permit (CER)	Published
Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)	Chemical	Import Permit (CER)	Published
Guidelines For Labeling Of Chemicals Manufactured In Nigeria	Chemical	GMP Requirement Labeling (CER)	Published
Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants)	Chemical	Listing Certificate New Applicants (CER)	Published
Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants)	Chemical	Import Permit New Applicants (CER)	Published
Guidelines For Renewal Of Listing Certificate For Chemical Marketers	Chemical	Listing Certificate Renewal (CER)	Published
Guidelines For Renewal Of Permit To Import Industrial And Laboratory Chemicals	Chemical	Import Permit Renewal (CER)	Published
Guidelines For Warehouse Inspection	Chemical	Warehouse Inspection Requirement (CER)	Published
Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)	Chemical	Import Permit (CER)	Published
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for Drug Products in Nigeria (Human Drugs)	Drugs	SMPC Guidelines (DR&R)	Published
NAFDAC Guidance Document And Guideline For Lot Release Of Human	Vaccines, Biologics & Medical Devices	Lot release (VBM-LSD)	Published
Guidelines For Change In Formulation Of Food And Feed Products	Food	GMP Requirement (FR&R)
Guideline For Production Inspection Of Chemical Manf Facilities.pdf	Chemical	Guidance Document (CER)	Published
GMP Guidelines For Chemical And Chemical Products.pdf	Chemical	GMP Requirement (CER)	Published
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria	Drugs	GMP Requirement (DER)	Published
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria	Drugs	GMP Requirement (DER)	Published
Guidelines for Registration of Animal Feed Made in Nigeria	Veterinary	Local Registration (R&R)	Published
Guidelines for Advertisement Control of Food Products in Nigeria	Food	Advert Guidelines (R&R)	Published
Guidelines for Registration of Imported Animal Feed in Nigeria	Veterinary	Import Registration (R&R)	Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021	Drugs	GMP Requirement (DER)	Published
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In Nigeria	Drugs	GMP Requirement (DER)	Published
NAFDAC Good Pharmacovigilance Practice Guidelines	Drugs	GPP Requirement (PVPMS)	Published
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines	Drugs	Licensing Access to Covid-19 Vaccines(DR&R)	Published
Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised).pdf	Food	GMP Requirement (FSAN)	Uncontrolled
Food Hygienic Practices Guidelines NGFHP.pdf	Food	Guidance Document (FSAN)	Uncontrolled
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)	Drugs	API Requirement (DER)
Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1	General	Consumer Complaints (QMS)	Published
Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in Nigeria	General	Guidance Document (DR&R)
Guidance to Applicants for Registration of Herbal Medicines Made in Nigeria	Herbal	Guidance Document (DR&R)
NAFDAC Guidelines on Good Review Practice	Regulated Products	Quality Guidelines (DR&R)	Published
Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)	Chemical	Listing Requirement (CER)	Published
Guidance Document for Submission of Application in the CTD Format Vaccines for Human Use	Drugs	Guidance Document (DR&R)	Published
Guideline for Approval to Import Donated Items by Non-Governmental Organizations	General	Import Permit (PID)	Published
Guidelines for Approval To Import Raw Material for Machine Trial or Research Purpose	General	Import Permit (PID)	Published
Guidelines for Approval of Authorization to Open Form M	General	GMP Requirement (PID)	Published
Guidelines for Approval for Letter of Non-Objection	General	GMP Requirement (PID)	Published
Guidelines For Complaints Resolution	General	Consumer Complaints (Reforms)	Published
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021	General	GMP Requirement (DER)	Published
Guidelines on Variations to a Registered Vaccine for Humans	General	Variation Guidelines (DR&R)	Published
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in Nigeria	Herbal	Renewal Registration Requirement (DR&R)	Published
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in Nigeria	Herbal	Renewal Registration Requirement (DR&R)	Published
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration Procedure	Drugs	Registration Requirement (DR&R)	Published
Guidelines For Labeling Of Investigational Medicinal Products	Drugs	GMP Labeling (DER)	Published
Guidelines For Importation And Release Of Investigational Medicinal Products	Drugs	Quality Guidelines (DER)	Published	15-Nov-28
NAFDAC Guidelines on Variation to Registered Pharmaceutical Product	Drugs	Variation Guidelines (DR&R)	Published
Guidelines for Approval to Import Products by Government Agencies, Multinationals Organization	General	Guidance Document (PID)	Published
Guideline for Form M Online Application 2019	General	Guidance Document (PID)	Published
Guideline for NOC Online Application 2019	General	Guidance Document (PID)	Published
Biosimilar Guidance Document	Drugs	Quality Guidance Document (DR&R)	Published
Guidelines for Registration of Biosimilars in Nigeria	Drugs	Local Registration (DR&R)	Published
Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)	Chemical	Listing Certificate (CER)	Published
Guidelines for Issuance of Permit to Clear for Restricted and Agro Chemicals	Chemical	Clearance Permit (CER)	Published
Guidelines for Issuance of Permit to Import Laboratory and Industrial Chemicals	Chemical	Import Permit (CER)	Published
Guidelines for Renewal of Import Permit for Laboratory and Industrial Chemicals	Chemical	Import Permit Renewal (CER)	Published
Guidelines for the Issuance of Import Permit for Restricted and Agro Chemicals	Chemical	Import Permit (CER)	Published
Guidelines for the Renewal of Listing Certificate for Chemical Marketers	Chemical	Listing Certificate Renewal (CER)	Published
Guidelines for Obtaining Permit to Clear Narcotic Drugs, Psychotropic Substances and Drug Precursors	Narcotic	Clearance Permit (NCS)	Published
Guidelines for Obtaining Permit to Clear Precursor Chemicals	Narcotic	Clearance Permit (NCS)	Published
Guidelines for Obtaining Permit for Importation of Narcotic Drugs, Psychotropic Substances and Drug Precursors	Narcotic	Import Permit (NCS)	Published
Guidelines for Obtaining Permit to Import Precursor Chemicals	Narcotic	Import Permit (NCS)	Published
Guidelines for Obtaining Permit for Importation of Schedule 1 Narcotic Drugs	Narcotic	Import Permit (NCS)	Published
Guidelines for Warehouse Inspection	Narcotic	Warehouse Inspection Requirement (NCS)	Published
Guidelines for the Registration of Imported Animal Feeds	General	Import Registration (R&R)	Published
Guidelines for Registration of Imported Cosmetics in Nigeria	Cosmetics	Import Registration (DR&R)	Published
Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)	Drugs	Import Registration (DR&R)	Published
Guidelines for Registration of Imported Food Products in Nigeria	Food	Import Registration (R&R)	Published
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in Nigeria	Herbal	Import Registration (DR&R)	Published
Guidelines for Registration of Imported Pesticides in Nigeria	Chemical	Import Registration (DR&R)	Published
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in Nigeria	Herbal	Local Registration (DR&R)	Published
Guidelines for Registration of Cosmetics Made in Nigeria	Cosmetics	Local Registration (DR&R)	Published
Guidelines for Registration of Drug Products Made in Nigeria Human and Veterinary	Drugs	Local Registration (DR&R)	Published
Guidelines for Registration of Food Products and Packaged Water Made in Nigeria	Food	Local Registration (R&R)	Published
Guidelines for the Registration of Pesticides made in Nigeria	Chemical	Local Registration (DR&R)	Published
Guidelines for the Inspection of Warehouses	Veterinary	Warehouse Inspection Requirement (VMAP)	Published
Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs	Veterinary	GMP Requirement (Inspection)	Published
Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility Renewal	Veterinary	Listing Requirement (Renewal)	Published
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling Facility	Veterinary	GMP Requirement	Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal	Veterinary	Listing Requirement	Published
Guidelines for Issuance of Permit to Import Field Trial Samples	Veterinary	Import Permit	Published
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal Renewal	Veterinary	Import Permit	Published
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New Applicant	Veterinary	Import Permit	Published
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers	Veterinary	Import Permit	Published
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers Renewal	Veterinary	Import Permit	Published
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food Premixes	Veterinary	GMP Requirement (Inspection)	Published
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in Nigeria	Veterinary	GMP Requirement (Inspection)	Published
Guidelines for Inspection of Facilities for the Manufacture of Medicated Feed	Veterinary	GMP Requirement (Inspection)	Published
Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics	Veterinary	GMP Requirement (Inspection)	Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal	Veterinary	Listing Requirement	Published
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products	Drugs	Listing Requirement (I&E)	Published
Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria.pdf	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidelines for Inspection and Requirements for Bread Manufacturing Facility	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria.pdf	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidelines for Clearing of Imported Donated Items in Nigeria	General	Import Clearance Permit (PID)	Published
Guidelines for Clearing Imported Bulk Food Animal Feed and Food Raw Materials and Animal Feeds at Ports of Entry in Nigeria	Food	Import Clearance Permit (PID)	Published
Guidelines for Clearing imported Narcotic & Controlled Substances, Pharm Raw Materials	Narcotics	Import Clearance Permit (PID)	Published
Guidelines For Clearing Imported Finished Pharmaceutical (Human And Veterinary) Products at Ports of Entry in Nigeria	Herbal	Import Clearance Permit (PID)	Published
Guidelines for Clearing Imported Regulated Food Supermarket Items Restaurant Operators at Ports of Entry in Nigeria	Food	Import Clearance Permit (PID)	Published
Guidelines for Clearing of Cosmetics and Medical Device	Cosmetic, Medical Devices	Import Clearance Permit (PID)	Published
Guidelines for Clearing of Imported General Chemicals and Raw Materials	Chemical	Import Clearance Permit (PID)	Published
Guidelines for Fast Track Clearing of Imported NAFDAC Regulated Products & Bulk Raw Materials	General	Import Clearance Permit (PID)	Published
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal Use	Food, Other Regulated Products	Export Permit (PID)	Published
NAFDAC MAS Guidelines	General	Mobile Authentication Service (PMS)	Published
NAFDAC Guidelines on Good Pharmacovigilance Practice	General	GMP Requirement (PV/PMS)	Published
Label Guidance For Pharmaceutical Products	General	GMP Labelling (DR&R)	Published
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products	Drugs	Registration Requirement (DR&R)	Published
NAFDAC GMP Guidelines For Cosmetics Products 2021	Cosmetics	GMP Requirement (DER)	Published
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing Facilities	Cosmetics	GMP Inspection (DER)	Published
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing Facilities	Herbal	GMP Inspection (DER)	Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021	Drugs	GMP Inspection (DER)	Published
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics Products	Cosmetics	GMP Inspection (DER)	Published
Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & Biologics	Vaccines & Biologics	GSP & GDP Inspection (DER)	Published
Label Guidance For Herbal Medicines And Dietary Supplement	Herbal	GMP Labelling (DR&R)	Published
Guidelines for the Global Listing of Supermarket Items (GLSI)	Regulated Products	Global Listing (DR&R)	Published
Dossier Submission Guide	General	Guidance Document (DR&R)	Published
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished Chemicals	Regulated Products	GMP Advertisement (DR&R)	Published
Guideline for Donated Medical Products in Nigeria	Regulated Products	Guidance Document (DR&R)	Published
Guideline for Operation of Service Drugs and Orphan Drug Scheme	Drugs	Operation Guidelines (DR&R)	Published
Guidelines for Renewal of Certificate of Registration for Drug Products (Human and Veterinary Drugs)	Regulated Products	Renewal Registration Requirement (DR&R)	Published
Guidelines For The Preparation of Product Dossiers in the Common Technical Document (CTD) Form	General	Quality Guidance Document (DR&R)	Published
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00	Drugs	Traceability	Published
Guidance on Emergency Use Authorization for Medical Products	Regulated Products	Guidance Document (DR&R)	Published
NAFDAC Guidelines on Post-Marketing Surveillance of Medical Products	Regulated Products	Guidance Document (PMS)	Published
Guidelines For Qualified Person For Pharmacovigilance	Regulated Products	GMP Inspection (PV)	Published
Guidance Manual for Pharmacovigilance Focal Points in Nigerian Healthcare Facilities	Regulated Products	Guidance Document (PV)	Published
Pharmacovigilance Inspection Guidelines For Nigeria Regulated Drugs	Drugs	GMP Inspection (PV)	Published
Nigerian Guidelines for Detecting and Reporting of Adverse Reactions for Pharmaceutical Products and Medical Devices	Regulated Products	GMP Requirement (PV)	Published
Guidelines For UMC Review Nigeria Industry E-Reporting Manual Version	Regulated Products	Guidance Document (PV)	Published
Guidelines on the Investigation of Bioequivalence 2024	Drugs	GMP Inspection (DER)	Published
Guidelines for Listing of Exporters of NAFDAC Regulated Products in Nigeria	General	GMP Requirement (PID)	Published
Guidelines for Issuance of Export E-Licenses for NAFDAC Regulated Products	General	Export Permit (PID)	Published
Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in Nigeria	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidelines For Production Inspection Of Micro Scale Food Manufacturing Facilities In Nigeria (New Applicants)	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidelines For Production Inspection Of Small Scale Food Enterprises In Nigeria (New Applicants)	Food	GMP Inspection Requirement (FSAN)	Uncontrolled
Guidance Document on Chemistry, Manufacturing, Control (CMC) and Lot Release for Finished Vaccine or Biological Medicinal Product	Vaccines, Biologics & Medical Devices	Lot release (VBM-LSD)	Published
Guideline for Risk Categorization of Narcotics and Controlled Substances	Regulated Products	Guidance Document (NCS)	Published
Guidelines for Registration of Software as a Medical Device (SaMD) in Nigeria	Medical Devices	Registration Requirement (DR&R)	Published
Guidelines For Clinical Trials In Emergencies In Nigeria	Drugs	Clinical Trial (DER)	Published
Guidelines For Clinical Trials In Paediatric Populations	Drugs	Clinical Trial (DER)	Published
Guidelines For Clinical Trials Process Timelines	Drugs	Clinical Trial (DER)	Published
Guidelines For Clinical Trial Protocol Development	Drugs	Clinical Trial (DER)	Published
Guidelines For Importation & Release Of Investigational Medicinal Products	Drugs	Clinical Trial (DER)	Published
Guidelines For Labelling Of Investigational Medicinal Products	Drugs	Clinical Trial (DER)	Published
Guidelines For Submission Of Clinical Trial Progress Report	Drugs	Clinical Trial (DER)	Published
NAFDAC Good Clinical Practice Guidelines 2020	Drugs	Clinical Trial (DER)	Published
NAFDAC GMP For Medical Devices, IVDs, Related Products Guidelines 2024	Regulated Products	Guidance Document (DER)	Published
NAFDAC Good Distribution Practice Guidelines For Pharmaceutical Products	Regulated Products	GDP Requirement (PMS)	Published
NAFDAC Guidelines for the Recall of Defective Medical Products	Regulated Products	Guidance Document (PMS)	Published
Guidelines for Clinical Trial Application in Nigeria	Drugs	Clinical Trial (DER)	Published
Guidelines for Conduct of Clinical Trials During Emergencies	Regulated Products	Clinical Trial (DER)	Published
Guidelines for Compilation of a Product Dossier for Registration of Non-In Vitro Diagnostic (nIVD ToC)	Regulated Products	Registration Requirement (VBM-R&R)	Published
Guidelines for Good Refurbishment Practice of Medical Devices (NGRPMD)	Medical Devices	Guidance Document (VBM-R&R)	Published
Guidelines For Registration Of Medical Devices In Nigeria	Medical Devices	Registration Requirement (VBM-R&R)	Published
Guidelines For Renewal Of Certificate Of Product Registration For Medical Devices In Nigeria	Medical Devices	Certificate Renewal (VBM-R&R)	Published
Guidelines on the Role of Standards in the Assessment of Medical Devices	Medical Devices	Guidance Document (VBM-R&R)	Published
Guidelines On Variations To Registered Medical Devices Including In Vitro Diagnostics And Related Products	Regulated Products	Registration Requirement (VBM-R&R)	Published
NAFDAC Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human Use	Drugs	Registration Requirement (DR&R)	Published
Guidelines for Compilation of a Product Dossier for Registration of In Vitro Diagnostics - IMDRF ToC	Regulated Products	Registration Requirement (VBM-R&R)	Published

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