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.

Procedure for Registration of Medical Devices and In Vitro Diagnostics With NAFDAC

To register a medical device or an IVD with the NAFDAC, an Applicant should take the following steps:

1. Write an Application letter on the company’s letterhead to the address below:

The Director-General (NAFDAC),

ATTENTION: The Director, Registration and Regulatory Affairs (R & R) Directorate, Ground Floor, NAFDAC Office Complex, Isolo Industrial Estate, Oshodi-Apapa Express Way, Isolo, and Lagos State.

An online application form is also to be purchased, completed and downloaded from the NAFDAC Product Registration Website. Note that a separate application form is to be completed for different products. Some details to be included in the form include:

• Manufacturer Information such as Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the details of contact person overseas (name, telephone no, email address); name of airport closest to the location; and guide map illustrating the shortest land/air route to the factory overseas (where applicable)
• Local Company’s Tax Identification Number
• Details of Applicant, such as; name, contact, address, qualification, job title, warehouse address, etc.
• Number of medical devices
• Name(s) of medical device
• Details of the products, including types and classes of device, medical device group or medical device family
• Names of four (4) staff including production manager, production staff, quality control, and marketing director, where applicable.

1. Attach at least two (2) sets of the following documents to the application letter and printed application form:
2. Evidence of Business Incorporation. For Micro, Small and Medium Enterprises (MSMEs); evidence of Business name registration.
3. Notarised Declaration (for imported devices). To be completed (typed), signed by Declarant, and notarized by a Notary Public in Nigeria.
4. Power of Attorney (POA), if applying on behalf of a manufacturer outside Nigeria. The POA should be valid for at least 5 years and must be signed by a senior company official. It must also be notarized in the country of manufacture; state the authority to register the product with NAFDAC and indicate ownership of the brand name or trademark.
5. Contract Manufacturing Agreement (CMA), where the applicant is applying on behalf of his company. The CMA should be signed by the Manufacturer and the Applicant, and must be notarized in the country of manufacture. The CMA should also state the names of all the products to be registered in a clear language.
6. Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of the Trademark/Brand name as the case may be.
7. Evidence of satisfactory Inspection issued by the relevant Directorate or Good Manufacturing Practice (GMP) certificate for product line (for companies with registered products).
8. Product Labels/artwork.
9. Product Samples
10. Comprehensive Certificate of Analysis. The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain the under listed information:
11. The brand name of the product
12. The batch number of the product
13. The manufacturing and expiry dates
14. The name, designation, and signature of the analyst.
15. Evidence of payment to NAFDAC.
16. Upon a satisfactory documentation review, GMP inspection of the production facility and laboratory analysis of products, products are presented for Approval Meetings. During the approval meeting, if the products’ labels do not meet the compliance requirements, compliant artworks may be submitted with a commitment letter from the manufacturer (stating that the commercial products will comply with the requirements).
17. If a product is successfully approved during the approval meeting, a Notification of Registration will be issued to the Applicant, while a Compliance Directive will be issued for products not approved.
18. Finally, the applicant for a successful product registration is issued a Certificate of Registration which is valid for 5 years.

How Much Does It Cost to Register A Medical Device or An In Vitro Diagnostic Product With NAFDAC?

Below is a schedule of the costs involved in registering a medical device or an In Vitro Diagnostic product with NAFDAC.

How Long Does It Take to Register A Medical Device or An In Vitro Diagnostic Product with NAFDAC?

The timeline for product registration from acceptance of submissions to issuance of Registration Number is one hundred and twenty (120) working days, provided that all documents are provided timely and in their correct formats.

Conclusion

In conclusion, it is imperative to note that a successful registration of medical devices or in vitro diagnostics does not grant an advertisement permit of the product. Advertising permit is granted by the Registration and Regulatory Affairs Directorate, after careful evaluation of the claims made to ensure that exposed materials correspond to the approvals given.

Registering a medical device helps build trust with healthcare providers and consumers—establishing your business as a reliable supplier of quality medical devices.

Also see our article on NAFDAC Labelling Requirements for Medical Devices, In Vitro Diagnostics and Related Product.