First Schedule: Rules for Classification of Medical Devices

The labelling of a medical device, in vitro diagnostic and related product shall be in accordance with the
Agency’s extant Medical Devices and Related Products Labelling Regulations.

• Clinical trial should be conducted in accordance with the approved Protocol, Good Clinical Practice (GCP) and Agency’s requirements.

For parties interested in carrying out clinical trial in Nigeria, the two responsible regulatory authorities are:

1. National Agency for Food and Drug Administration and Control (NAFDAC): The Agency is responsible for protocol review and authorization of clinical trial before it is conducted in Nigeria. It is also responsible for carrying out inspection of trial sites to monitor the conduct of authorized studies to ensure that well-being and safety of the participants is protected and credible data is obtained from the study.
2. National Health Research Ethics Committee (NHREC): The Committee is responsible for accreditation of Independent Ethics Committee (IEC) and or Institutional Review Board (IRB) that give ethical opinion on study protocols depending on the number of trial sites involved. Visit ( nhrec.net ) for more information.

1 The manufacturer should attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance as documented in a written “Declaration of Conformity” (DOC). At a minimum, this declaration should contain the following information:
a. A statement that each device that is the subject of the declaration

i. complies with the applicable Essential Principles for Safety and Performance,
ii. has been classified according to the classification rules, and,
iii. has met all the applicable conformity assessment  elements.

b. A Global Medical Device code and term for the device(s).

c. Date from which the Declaration of Conformity is valid.

d. Name and address of the device manufacturer; and,

e. The name, position, and signature of the responsible person who has been authorized to complete the Declaration of Conformity on behalf of the manufacturer

USERs are encouraged to report all adverse incidents as soon as possible. Serious cases ought to be reported by the fastest means possible. Initial incident reports should contain as much relevant detail (e.g. Medical Device name, type, model … etc.) as is immediately available, but
reporting ought not to be delayed for the sake of gathering additional information.

1. Reporting Guidance
An adverse incident is an event during the use of the device which might lead to or might have led to the death of a patient, user or other persons or to a serious deterioration in their state of health.
This should be reported to the NPC/NAFDAC.

1.1. What to Report
USERs or those given specific responsibility for reporting incidents that have occurred with medical devices should report incidents that meet the criteria within this guideline to the manufacturer and/or to NPCNAFDAC.

1.2. Who Should Report
The NPC/NAFDAC strongly encourages those who have experienced a safety issue with a medical device to report that issue to us. A voluntary reporting system is currently operated for users of medical devices, healthcare professionals or any other person who identifies a medical device safety issue.

A field safety corrective action (FSCA) is an action taken by a MANUFACTURER to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions, whether associated with direct or indirect
harm, should be reported and should be notified via a Field Safety Notice (FSN).

The Field Safety Corrective Actions (FSCA) may include, for example:
▪ The repair/replace/return of a medical device to the supplier;
▪ Device modification/adjustment/relabelling;
▪ Advice given by manufacturer regarding the use of the device and/or the follow-up (monitoring)
of patients, users or others.

The advertisement of medical device, in vitro diagnostic and related product shall be in accordance with
the Agency’s extant Medical Device, In Vitro Diagnostic and Related Product Advertisement Regulations. Advertisements must be approved by NAFDAC before being released to the public, and only registered devices can be advertised. The approval process typically takes 14-21 working day. 

The registration of a medical device and related product under these Regulations shall, except cancelled,
be valid for a period of five years or as may be prescribed by the Agency and may be renewed.