A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life.
Medical Device Registration In Ghana
Regulatory Authority:
Medical Device Department (MDD) of the Food and Drugs Authority (FDA) Ghana.
Classification:
I, II, III, IV
Procedure:
Medical Devices are subject to registration.
A Local Representative (Registrant) must be appointed and he will be responsible for the registration process with the competent Authority. Furthermore, device samples shall be submitted for on-site testing.
Once the registration process is complete, the importer shall obtain a permit for registered devices import.
Applicant:
Foreign manufacturer via local representative (Registrant).
Timeframe and fees:
Registration fees: 5,269.50 Ghana Cedi
Registration timeframe: 3 – 12 months
Labeling and documentation language:
Documentation and labeling should be provided in English.
Useful information:
Following registration, all devices are subject to post-market surveillance. Safety, quality, and performance are continuously monitored.
What is a medical device registry?
A medical device registry is focused on tracking the effectiveness, safety, and value of medical devices.
Device registries come in several forms.
Medical specialty organizations may collect data on various devices used for procedures or conditions, as part of their clinical data registries.
What is a Type 2 Medical Device?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category.
Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.