It is required to have a valid license before you manufacture or import any medical device in Ghana and registering medical devices with the relevant authorities is key. The Food and Drugs Authority (FDA) is the regulatory body that ensures all medical devices are safe for use. Additionally, they ensure locally produced or imported medical devices meet the required quality and standards.
In this article, we will discuss the requirements and processes involved in registering medical devices.
What is a Medical Device ?
A Medical Device is any device used for medical purposes.
Additionally, let us consider the definition and description given by World Health Organisation (WHO).
According to WHO, a "Medical device' means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) for:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices
- providing information by means of in vitro examination of specimens derived from the human body";
Therefore, you cannot classify or consider any device as a medical device unless it meets the above description and conforms to standards.
Which Agency is responsible for the registration of medical devices in Ghana?
Before a Medical Device can be imported for sale or manufactured locally, it must go through testing, trial and checks to ensure safety and conformity with standards. The Food and Drugs Authority (FDA) is the Agency under the Ministry of Health that regulates medical devices. The FDA as part of its mandate provides and enforces standards for medical devices and household chemical substances.
What are the requirements for registering Medical Devices?
a. Cover letter
b. Applicant's details
- Can be a manufacturer
- Or an importer
- and a non- resident applicant is required to appoint a local agent with the requisite mandate to represent the applicant)
c. Local Agent's details
- a local agent should be a corporate body registered in Ghana.
- Should have a mandate from the applicant
- Responsible to monitor the device on the market and inform the Authority on any relevant issues relating to a registered device
- Facilitate communication between applicant and the Authority.
- Handle device recalls
- Provide technical support and services to users or registered device(s).
d. Classification of applications
During the registration process, the applicant has to specify if the application is new, renewal or variation of medical device.
New applications for registering medical devices
- a separate application is required for each single medical device or medical device group or medical device family or medical device system.
- One original hard-copy and one electronic copy in a text selectable Portable Document format (PDF) on a CD-Rom shall be submitted.
- Samples of the product as per FDA sample schedule
- Non-refundable application fee
Applications for renewal of registration of medical devices
Renewal of registration shall be made at least three months before the expiry of registration. The following shall be submitted:
- Dully completed renewal forms
- Samples of products
- Non-refundable application fee
Application for variation of a registered medical device
Any application for variation to a registered product shall indicate any significant change(s) that could reasonably be expected to affect the safety, quality or good performance of a registered product. This may include;
- The manufacturing process, facility or equipment
- The manufacturing quality control procedures, including methods, tests or procedures used to control the quality, purity, safety and sterility of the device or of the material used in its manufacture.
- The design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories
- The intended use of the device, including any new or extended use, any addition or deletion of a contraindication for the device, and any change to the period used to establish its expiry date.
- The requisite variation fees
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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.