How To Register Medical Devices & In Vitro Diagnostics Made In Or Imported Into Nigeria With NAFDAC

Introduction

A medical device is any instrument, apparatus, contrivance (including components, parts, and accessories) intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of any disease, disorder, abnormal physical state, or the symptoms, thereof, in man or in animal. An In Vitro Diagnostics (IVD), on the other hand, is any medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

Types and Classes of Medical Devices and In Vitro Diagnostics

There are 4 major types of medical devices and IVDs, including invasive, non-invasive, active, and special class medical devices. These types of medical devices and IVDs are further classified according to their level of risks, such that;

1. Class A – are low risks for medical devices, and low individual/public health risks for IVDs.
2. Class B – are low to moderate risks for medical devices, and low to moderate individual/public health risks for IVDs.
3. Class C – are moderate to high risks for medical devices, and moderate to high individual/public health risks for IVDs.
4. Class D – are high risks for medical devices, and high individual/public health risks for IVDs.

Below are the types of medical devices, IVDS and some of their examples:

1. Non-Invasive Devices

1. Devices that contact the skin

• Class A: Used as a barrier, compression, or to absorb fluids (e.g., bandages, cotton wool).
• Class B: For wounds breaching the dermis, mainly to manage wound environment (e.g., non-medicated dressings).
• Class C: For severe wounds healing by secondary intent (e.g., chronic ulcer dressings).

1. Devices that channel or store liquids/gases

• Class A: Store fluids/gases for future body use (e.g., gravity infusion sets).
• Class B: Connect to active devices or manage blood/body fluids (e.g., blood tubes, infusion sets).
• Class C: Blood bags.

1. Devices modifying blood/other fluids for body use

• Class B: Simple filtration or centrifugation.
• Class C: Chemical/biological modification (e.g., hemodialyzers).

1. Other non-invasive devices

• Class A: No direct body contact or only touch intact skin (e.g., urine collection bottles).

2. Invasive Devices

1. Devices for body orifices (not surgically invasive).

• Class A: Short-term use (e.g., examination gloves).
• Class B: Longer-term in non-sensitive areas (e.g., orthodontic materials).
• Class C: Long-term, sensitive areas (e.g., urethral stents).

1. Surgically invasive, short-term devices

• Class A: Reusable instruments (e.g., manual surgical tools).
• Class B: Standard surgical tools (e.g., scalpels).
• Class C: Hazardous or biological interaction (e.g., insulin pens, radioisotope catheters).
• Class D: Central nervous/heart-specific contact (e.g., spinal needles).

1. Surgically invasive, short-term, specific functions

• Class B: Routine surgical or post-op (e.g., infusion cannula).
• Class C/D: Chemical change or central nervous/heart monitoring (e.g., cardiovascular catheters).

1. Implantable or long-term surgically invasive

• Class B: Dental applications (e.g., crowns).
• Class C: General implants (e.g., bone plates).
• Class D: Life-sustaining, active, or biological implants (e.g., pacemakers, heart valves).

3. Active Devices

1. Therapeutic Devices

• Class B: Devices that use energy to treat, like muscle stimulators or hearing aids—generally safe if used correctly.
• Class C: Devices that use energy in a potentially dangerous way, like surgical lasers or ventilators—higher risk.

1. Diagnostic Devices

• Class B: Devices for basic diagnosis or monitoring, like ultrasound machines or blood pressure monitors—low to moderate risk.
• Devices that diagnose in life-threatening situations, like intensive care monitors—higher risk.

1. Drug/Fluid Administration

• Class B: Devices that deliver medicine or fluids safely, like feeding pumps—low to moderate risk.
• Devices with potentially risky drug/fluid delivery, like infusion pumps—higher risk.

1. Other Active Devices

• Class A: Basic, low-risk powered devices, like examination lamps or hospital beds.

Special Classes

1. Devices with Medicinal Components:

• Class D: Devices that contain medicines to help with their job, like antibiotic-coated dressings—highest risk.

1. Devices with Animal/Human Tissues

• Class D: Devices using tissues from animals or humans, like heart valves.
• Class A: If the device only touches unbroken skin, like leather orthopedic supports—very low risk.

1. Sterilizing/Disinfecting Devices

• Class B: Basic sterilizers, like those used for dental tools.
• Class C: Sterilizers for invasive tools, like endoscopes—higher risk.

1. Contact Lens Care

• Class C: Devices that clean or hydrate contact lenses.

1. Contraceptives

• Class C: Devices like condoms—moderate risk.
• Class D: If they're implantable, like intrauterine devices—highest risk.

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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.