The ultimate guide for Ethiopia medical device registration by FMHCACA (Food, Medicine, and Health Care Administration and Control Authority). Learn more about the medical device and IVD’s classification and approval process for Ethiopia.
Ethiopia is a nation in the northeastern segment of Africa, prevalently known as the Horn of Africa. Ethiopia’s population growth, migration, and urbanization are for the most part stressing both governments’ and ecosystems’ ability to give individuals with basic services.
Urbanization has consistently been expanding in Ethiopia, with two times of significantly rapid development. Ethiopia’s primary medical issues are said to be communicable (contagious) diseases worsened by poor sanitation and malnutrition.
More than 44 million individuals (more than half the population) don’t approach clean water. These issues are exacerbated by the lack of trained doctors and nurses and health facilities.
The Government of the Federal Republic of Ethiopia is the signatory to different worldwide conventions and treaties that secure the privileges of women and children. Its constitution accommodates the major rights and opportunities for women.
There is an endeavour being made to raise the social and economic status of women through disposing of all legal and standard practices, which block women’s equivalent participation in society and undermine their social status.
The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia was set up to protect the health and security of patients, clients, and different people by guaranteeing that manufacturers of medical devices pursue indicated methods during the design, manufacture, and marketing for the regulation of medicines and healthcare products.
Items managed by FMHACA comprise of human and veterinary drugs, radiopharmaceuticals, conventional medicines, insecticide, medical supplies and apparatus, hygienic items, cosmetics and raw and wrapping materials.
Medical Device Regulations and Classification in Ethiopia
Medical devices in Ethiopia are regulated by the FMHACA (Food, Medicine, and Health Care Administration and Control Authority) regulatory authority.
Method of Classification:
The method of classification for medical devices other than IVD medical devices stated in this Guideline depends on the intended use of the device, indications for use, the span of utilization, level of invasiveness, and local vs. systemic impact of the device. The technique of classification for IVD medical devices depends on individual vs. public health risk and on the intended use of the device either by lay persons and/or health professionals. The basic rationale for classification of the device is to proportionate the risk of the device and the technical requirement addition; the classification is risk-based, that is, the possibility the device presents to the patient and/or user is a main point which is determining to which class it is assigned.
Devices are classified according to risk, like in Class I being the lowest risk and Class III being the highest risk. In here IVD devices are also classified similarly, with Class A as the lowest risk and Class D as the highest.
Medical Device Classification in Ethiopia
IVD Classification in Ethiopia
Quality Management System
The ISO 13485 Certification is required for Medical devices which is a quality management system required for regulatory purposes which is an ISO standard, that represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.
Medical Devices and IVDs are subject to registration process. For representing the manufacturer to the Regulatory Authority, a local representative should be appointed. The appointed Local Representative should have a permit (issued by the Ministry of Trade) and a certificate of proficiency (issued by FMHACA) at the time of importation of the product. Application procedure must be performed by the Local Representative only.
Time Frame of the device registration:
In general, it takes about 3 to 6 months to get approval for new registrations. Just in case of alterations/changes from the current registrations, the timeframe will be actually the same.
The validity of License:
For five years the license is issued in Ethiopia.
Labeling and documentation language
Documentation and labeling can be provided in English. All classes of medical devices should be properly labeled based on the justification and information provided with the registration dossier.
The Labeling serves to communicate safety and performance-related information to users of medical devices and/or to patients, as well as to identify individual devices. Such data may show up on the device itself, on the packaging details segment.
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