Regulatory Process of In Vitro Diagnostic Medical devices in Ethiopia
Ethiopian Food and Drug Authority (EFDA) is a national regulatory body mandated to regulate food, medical products, tobaccos, and other similar products in the country before being distributed/marketed and used. Therefore, all devices which fulfil the medical device definition provided in the Ethiopian Food and Medicine Administration proclamation 1112/2019 are subject to the regulation and control by the EFDA. This proclamation put the legal framework for the regulation of medical devices in the country (please click here to read the proclamation). The definition for IVDs as well as Medical devices other than IVDs are consistent with the definitions provided in the guidance documents of International Medical device Regulators Forum (IMDRF).
The conformity assessment of IVD medical devices by EFDA follow the five elements recommended by the IMDRF.
- Quality management system.
- Declaration of Conformity.
- System for Post market surveillance.
- Technical documentation.
- Registration of establishment.
IVD Medical devices regulatory control levels by EFDA
Most of the EFDA’s regulatory documents and tools are developed targeting the products that are imported from abroad unless it is specified. This is because almost all medical devices that are being marketed in the country are imported devices. Therefore, a foreign manufacturer who is interested to place its products on Ethiopian market first need to make legal business linkage/connection with its local representative/agent whose competence is evaluated and accepted by the Authority. This connection is called- an Agency agreement. Next, the request to register the products with the EFDA is required prior to their importation. This is done by submitting the compiled product dossiers as per the Authority’s Guideline for Registration requirements of IVDs through the Authority’s online registration platform (eRIS). Please click here to download the registration requirements of IVD medical devices. The product dossier requirements described in the guideline for IVDs are adopted from IMDRF’s IVDs submission Table of Contents (ToC).
Although the Authority has developed the manufacturer’s QMS requirements and is at the moment working on to conduct inspection to check such requirements, currently the compliance to the QMS requirements is being verified through documentations required under chapter 1 (QMS conformance certificate issued by a recognized conformity assessment body), Chapter 6A, and Chapter 6B.
The means of evaluating the IVDs performance is also conducted by evaluating the technical documentations submitted in the Chapter 3 of the IVDs submission ToC that requires the manufacturers to submit the Analytical and clinical performance evaluation reports. Currently, the performance of the HIV serology rapid test kits are confirmed by the national reference laboratory testing before they are included in the national HIV testing algorithm. EFDA is establishing the system and fulfilling necessary infrastructure to conduct performance evaluation of this product which will enable the Authority to perform the evaluation test during the post-marketing surveillance.
In general, the review process of the product dossiers depend on the type of submission. 1) Registration applications of IVDs approved by one or more of stringent regulatory authority (SRA) or pre-qualified by WHO pass through the following review process:
- Screening for the completeness of the dossiers.
- Abridged review to verify sameness of the IVDs.
And other Non-SRA applications are-
- First screened to verify the completeness of the submitted dossiers.
- And the detail scientific review of dossiers by two different primary and secondary assessors who are given basic and advanced dossier assessment training.
What process is used in Ethiopia to evaluate and approve COVID-19 testing medical devices?
After WHO declared COVID-19, a disease caused by SARS-COV-2 as a public health emergency of international concern in December 2019, EFDA started to work on expediting premarket review and marketing authorization of medical devices that are used in the management of the disease. COVID-19 testing IVDs are one of these devices. The Authority has different regulatory pathways depending on the product types, the product’s risk class, the regulatory approval status of the product and the priority of diseases the product is intended to deal with. This way, COVID-19 testing IVD medical devices are given priority and have been evaluated and approved for marketing authorization as per the procedure provided in the following flowchart.
COVID-19 IVD Tests approval pathways
In order to avoid unnecessary delay of the applications, EFDA was directly recognizing all the available types of COVI-19 tests (antigen, antibody and NAT) that are authorized for emergency use by one or more of International Medical Devices Regulators Forum (IMDRF) member jurisdictions.
After 8 months of the outbreak of the pandemic, the Authority started to take the EUA by one or more of IMDRF member jurisdictions and EUL by WHO into consideration and conducting abridged assessment by focusing on only critical sections of the dossiers.