🇪🇹 Ethiopia medical device regulatory data

Ethiopian law makes it illegal to advertise medicine and medical devices or to promote within a health institution unless the appropriate executive organ grants permission to the advertisement (Proclamation No. 1112/2019, Art. 59(4)). This is an express statutory control on device advertising that names medical devices directly.

Any direct advertisement or promotion made in person to a health professional must be made through a medicine or medical device promoter who is duly authorised by the executive organ. The statute also prohibits offering or giving, directly or indirectly, any financial, in-kind or comparable benefit to a health professional in relation to promotion, beyond the maximum allowable gift defined by a directive issued to implement the proclamation. Advertising and promotion of regulated products must not be false and misleading, must be appropriate and ethical, and must comply with the proclamation and other applicable laws.

The advertiser and the advertisement disseminator of any regulated product, and, where the subject is promotion, the distributor or other person who caused the distribution of promotional materials, including a medicine and medical device promotion agent, have joint and several responsibilities for compliance with the proclamation and other applicable laws. Every mass media and advertisement disseminator has a duty to comply with a directive issued under the proclamation. Medical devices are within the class of regulated products to which these duties attach.

Marketing authorisations granted by EFDA are valid for five years and must be renewed every five years. The option to apply for re-registration opens when three months remain before the certificate expires, and applicants are advised to file at least two months before expiry because re-registration assessment may take time. A re-registration file requires an application letter, a valid QMS conformance certificate, a valid original free-sale or marketing authorisation certificate, a valid manufacturing licence, a declaration of conformity, a GMP certificate if applicable, a letter confirming no change or a summary of changes since the last EFDA approval, and device vigilance and post-market surveillance reports for sterile devices, devices with a measuring function and all Class III/C and above devices. If the certificate has already expired, the applicant must file a new registration application with the full requirements and assessment time of a new device.

The Ethiopian Food and Drug Authority (EFDA) is mandated to safeguard the health and safety of patients and users by assessing the quality, safety and effectiveness of medical devices prior to registration and marketing authorization. Article 20(1) of the Food and Medicines Proclamation No. 1112/2019 requires any medical device manufactured, imported, exported, stored, distributed, transported, sold, held, used or transferred in Ethiopia to be registered and granted marketing authorization. Device registration is administered by the Medical Device Evaluation and Market Authorization Lead Executive Office through the Electronic Regulatory Information System (eRIS).

EFDA classifies post-approval changes to a registered medical device into three categories. Category 1 changes are critical changes that require a new pre-market product registration application, including change to the intended purpose or indications for use (unless it is a reduction not arising from safety or performance concerns), change to the risk classification, software changes affecting safety, quality and performance, addition of variants outside the permissible grouping rules, changes to the medicinal substance in a device with an ancillary medicinal product, and addition of devices with different proprietary names or models that do not meet the grouping criteria. Category 2 changes are major changes requiring evaluation and EFDA endorsement before implementation, such as changes to manufacturing or sterilization facilities or processes. Category 3 changes are minor changes that may be implemented immediately. Where several changes are filed together the assessment follows the highest category in the application. Specified changes — for example labelling changes that only add or remove languages not required by EFDA — do not require a change notification at all.

EFDA classifies non-IVD medical devices into four risk classes, Class I (lowest risk) to Class IV (highest risk), and IVD medical devices into four classes A to D, using its classification guidelines (EFDA/GDL/041 for non-IVD devices and a separate guideline for IVD classification). Classification is based on the risk associated with the device at the point of use and is determined from the manufacturer's intended purpose, the effectiveness of the applied risk management techniques, the intended users and the mode of operation. GDL/041 applies rule-based classification for non-invasive, invasive, active and special devices, with factors including duration of contact, degree and site of invasiveness, whether the device delivers medicines or energy, biological effect, local versus systemic effect, contact with injured skin, diagnosis versus treatment, reusability and combination with other devices. The class determines the assessment route: Class I non-IVD and Class A IVD devices on the published low-risk list use the abbreviated/notification route under GDL/092.

EFDA states that a proper clinical evaluation demonstrates which clinical data are necessary and can be adequately contributed to by sources such as literature searching, prior clinical investigations including clinical data generated in other jurisdictions, clinical experience, or clinical data available from comparable devices; clinical data should be generated from clinical investigations only when data are unavailable or insufficient to demonstrate conformity to the Essential Principles. For long-established technologies the clinical investigation data that might be required for novel technologies may not be necessary, and available clinical data such as published literature, reports of clinical experience, post-market reports and adverse event data may in principle be adequate, provided that new risks have not been identified and the intended use has not changed.

For in vitro diagnostic medical devices, all claims for the clinical performance of the product must be supported by well-designed performance evaluations. EFDA accepts evaluations that have been carried out or coordinated by the manufacturer as well as evaluations carried out by bodies wholly independent of the manufacturer, and requires for each performance study submitted in the dossier a study description with record traceability, a study summary with a conclusion, and the full study protocol and report, including the site(s) where the study was performed and the geographical region of the subjects. Estimates of diagnostic or clinical sensitivity and specificity must be reported with 95% confidence intervals.

The clinical investigation authorization guideline applies to the conduct of clinical investigation on human beings in Ethiopia to assess the safety and/or performance of medical devices for regulatory purposes, and it applies to investigational devices that fulfil the medical device definition in Proclamation No. 1112/2019. The guideline states expressly that it does not apply to in vitro diagnostic medical devices, so IVD clinical performance evidence follows the IVD registration guideline instead.

EFDA states expressly which borderline products it does not regulate as medical devices: products that do not fulfil the Art. 2(22) definition are not considered a medical device and are not regulated by the Authority as a medical device. The guideline's non-exhaustive list of such products is multipurpose disinfectants or sterilisation agents that do not have medical use; general purpose products such as printers used with medical devices; devices used for non-medical purposes such as breast pumps; products for sports or leisure such as gym equipment with a heart-rate measuring function; personal protective equipment such as masks used to protect users from environmental pollution; and software such as telecare alarm systems. Products fulfilling the cosmetic definition are regulated as cosmetics instead.

EFDA regulates standalone software and artificial-intelligence-based software as medical devices. Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device, and EFDA states that SaMD is a medical device and includes in-vitro diagnostic medical devices. The scope of the guideline is all SaMD falling under the device or IVD definition irrespective of software technology or platform, and all medical devices incorporating artificial intelligence. It excludes software used in healthcare for non-medical purposes such as administrative or financial software, software used to make or maintain a device, software that are accessories to hardware devices unless they meet the SaMD definition, and software integral to the functioning of a hardware device.

Ethiopian law defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article and its accessories which does not achieve its primary intended action by pharmacological, immunological or metabolic means in or on the human body and is intended by the manufacturer to be used, alone or in combination, for a medical purpose, including devices for related medical use and for control of contraception. An in vitro medical device is defined separately as a device intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, and expressly includes reagents, calibrators, control materials, specimen receptacles, software or related other articles. Software is named in both definitions, and accessories are within the device definition.

The non-IVD registration dossier (GDL/097) is filed in two parts. The administrative chapter requires a stamped and signed cover letter, the agency agreement, evidence of the registration application fee, a valid ISO 13485 or CE full quality system certificate covering the manufacturing sites and products, a GMP certificate for applicable high-risk devices, an original and valid free-sale / marketing authorisation certificate, a risk-free TSE/BSE attestation and a declaration of conformity against the essential principles, classification rules and conformity assessment procedure. The technical chapters cover the general summary of submission, device description and principles of operation, packaging, development history, comparison with similar or previous generations, substantial equivalence, indications and contraindications, global market history including incidents and recalls, and the evidence for conformity with the essential principles. All attached data and documents must be in English and submitted as PDF through eRIS.

Before a medical device can be registered for use in Ethiopia an overseas manufacturer must sign an agency agreement with a local agent established in Ethiopia who acts on its behalf for registration and/or import, distribution and sale. The application letter must be issued by the licence holder/marketing authorisation holder naming that local agent as the party authorised to submit. A licence holder or manufacturer may not authorise more than one registrant or local agent for the registration of the same product at the same time. The agreement must record the agent's position (first, second, third agent), assign responsibility for device vigilance and post-marketing reporting to both parties, and require the manufacturer/licence holder and local representative to collect and submit device safety and performance evidence within one year of marketing in Ethiopia for all Class III and higher devices and Class C and higher IVD devices.

The device good storage and distribution guideline applies to all parties in the medical device supply chain in Ethiopia, including manufacturers, importers, wholesalers and retail outlets. Firms must ensure that medical devices are only sold or distributed to persons or entities authorised to acquire them, and must retain copies of written proof of that authorisation or of the special permit obtained before distributing to them. Records of dispatch must contain sufficient information to enable traceability of the devices and to facilitate the recall of a batch. Distribution and storage facilities are subject to inspection by the Authority's inspectors, at periodic intervals or as a surprise visit, and the inspected firm must submit CAPA for the reported non-compliances within the period requested by the inspectors but not exceeding one month from receipt of the report.

Any person who wants to import, export or wholesale medicine and medical device in Ethiopia must first obtain a certificate of competence from the Ethiopian Food and Drug Authority. Directive No. 872/2022 applies to medicine and medical device importers, exporters and wholesalers, and its licensing rules are drafted for both product types together rather than for medicines alone. The application is made on the form prescribed by the Authority, with the appropriate service fee paid and the original supporting documents submitted online through the electronic regulatory information system at ilicense.efda.gov.et; the supporting documents include the educational evidence, employment agreement or contract and working-experience letter of the technical manager and the store manager. A licence holder that wants an additional warehouse must meet the store-manager requirements and have the new information written on the original certificate of competence, while opening a branch requires fulfilling all the requirements. A person may have only one import licence but may operate wholesale distribution branches at different sites in the country. The certificate of competence is renewed annually, and it is displayed at the technical premises and returned when it lapses. Article 23(1) of Proclamation No. 1112/2019 separately prohibits engaging in medical device trade without registration and licensing by the competent organ.

Importers and institutions intending to import medical devices must apply online for a purchase order or pre-import permit through the eRIS system, uploading the proforma invoice, supporting letter as applicable, GMP certificate and donation certificate where relevant. The import permit is valid for twelve months, is not transferable and may cover one or more shipments, including partial shipments; once it has expired or been cancelled no further importation or supply at any quantity is permitted. For all imported medical devices the port of entry requires, among the administrative documents, a valid purchase order or pre-import permit generated through eRIS or a hard copy authorised by the responsible EFDA directorate, a valid registration certificate, and a certificate of competency (COC).

EFDA/GDL/046 Table 6 fixes the medical device registration service fees under the Rate of Service Fees issued by Council of Ministers Regulation No. 370/2015: new application screening 350 birr; new application evaluation 1,300 birr; laboratory test USD 200; renewal application evaluation 870 birr; major variation application evaluation 870 birr; minor variation application evaluation 650 birr; agency agreement USD 50. All fees are payable before submitting the dossier or in parallel with the application submission. Applicants complete the payment request forms annexed to the guideline and obtain the Authority's approval before payment.

All medical device labelling must be in English and/or Amharic, and labels must be legible, indelible and not easily detachable; any product information on the labelling must be based on scientific justification (EFDA/GDL/084 §3.1). Label content is prescribed in GDL/084 §3.4: for the device itself, device name, batch/lot or model and serial number, manufacturing and/or expiry date, manufacturer/licence holder name and address, country of origin, technical details and warnings; for the package label, additionally intended use, storage conditions and net quantity. Separately, for low-risk devices filed under GDL/092, §5.1.5 requires all label statements in English or Amharic, product information that does not vary significantly from claims made in other jurisdictions, and (where applicable) a unique identification/device code, an associated barcode and the CE mark on the item or primary packaging for CE-marked devices; brochures or manuals for instructions for use and assembly must be in English or Amharic.

The primary instrument is the Food and Medicine Administration Proclamation No. 1112/2019. Article 20(1) mandates registration and marketing authorization of medical devices; Article 19(1) provides that the rigour of regulatory assessment be commensurate with the product's type, nature and potential risk to human health (the basis for the four risk classes and the low-risk abbreviated route); Article 23(1) prohibits any institution from engaging in medical device trade unless registered and licensed. The operative instruments are the EFDA guideline series: GDL/046 (general marketing authorization), GDL/097 (non-IVD registration requirements), GDL/087 (IVD registration requirements), GDL/092 (low-risk devices), GDL/041 (non-IVD classification), GDL/043 (IVD classification) and GDL/098 (post-approval change).

EFDA places the post-market surveillance obligation on the manufacturer: manufacturers must perform post-market surveillance to continuously monitor their medical device and report findings in a timely way as required by Art. 38(2) of Proclamation 1112/2019, establish a documented procedure to conduct PMS and provide early warning of quality problems for input into corrective and preventive action processes, continue collecting and evaluating information on the device during production and post-production, set a procedure allowing early detection of undesirable effects, have their own PMS plan, decide further actions such as feedback into risk management, incident reporting, correction or an FSCA communicated to users through a Field Safety Notice, and fully or partially cover the costs of PMS when EFDA conducts it. Importers and wholesalers must coordinate and support the manufacturer's PMS, liaise PMS issues between EFDA and the manufacturer, implement recommended actions and share PMS costs when EFDA conducts the PMS.

EFDA may accept periodic summary or trend reports from a manufacturer or authorised representative after one or more initial reports have been issued and evaluated, on a format and frequency agreed with the Authority for certain types of device and incidents. Incidents described in a field safety notice that occur after an FSN has been issued and an FSCA conducted must still be reported, with the manufacturer agreeing the frequency and content of the periodic safety summary report; common and well-documented incidents that have already been reported and assessed may be exempted from individual reporting and moved to periodic summary reporting, subject to agreed trigger levels, with an interim trend report required whenever trigger levels are exceeded. A trend report must be made to EFDA where there is a significant increase in the rate of already reportable incidents, incidents usually exempt from reporting, or incidents scheduled for periodic reporting. Where a manufacturer has received the agreement of another country's national regulatory authority to switch to periodic summary or trend reporting, it must inform EFDA of that agreement and its modalities.

Device registration and marketing authorisation applications are submitted online through EFDA's Electronic Regulatory Information System (eRIS) at www.eris.efda.gov.et, after obtaining a username and password from the authorised person in the Authority's Registration department. Establishment licensing for importers, exporters and wholesalers is applied for through the EFDA licence portal at https://www.ilicense.efda.gov.et. Application forms, the agency agreement form, the payment request forms and the declaration of conformity and global market history templates are annexed to GDL/046 (Annexes II to VII).

The EFDA medical device GMP site inspection programme applies to medical devices to be registered with the Authority that are subject to GMP inspection, and it applies to both foreign and local manufacturers of such devices. Foreign facility inspection reports are distributed for review through the Authority's GMP quality assurance process, and the guideline is expressly the instrument governing both the local and the foreign inspection programme.

EFDA's conformity assessment of the manufacturer's QMS depends on the device class. Manufacturers of Class I devices and Class A IVDs must implement and maintain the basic elements of a QMS but may exclude design and development controls; the QMS of Class I and II devices and Class A and B IVDs is normally not subjected to a premarket on-site audit, with the exception of sterility or measuring-function assurance, though EFDA may audit those facilities if it deems it necessary. Manufacturers of Class III and IV devices and Class C and D IVDs must maintain an effective QMS including design and development controls and comply with EFDA's current medical device GMP; for those classes EFDA reviews relevant existing certification and/or regulatory audit reports and undertakes periodic on-site audits of the manufacturer's facility, and may issue a GMP certificate listing the covered devices and its validity period on satisfactory findings.

For registration, the manufacturer must hold valid and genuine certificates confirming implementation of a good quality management system in the device's production process. EFDA states that one of the certificates to be considered is an ISO 13485 certificate where it is issued by another notified body or registrar, and CE full quality system certificates (QMS and Annex II.3 MDD) covering the scope of the products where issued by another notified body. For applicable high-risk medical devices a copy of a valid certificate of compliance with medical device GMP must also be provided.

Once the manufacturer or its authorised representative has identified the problem and determined that an FSCA is needed for a non-conforming device, the manufacturer or its authorised representative is responsible for notifying the authority, health professionals, operators and the public for all classes of FSCA within 24 hours for investigation and not to use it. If the device poses a potentially significant hazard during weekends or public holidays, the product owner or user may immediately take precautionary measures to block or quarantine the device without notifying the authority; the guideline then states that 'after 72 hours' the manufacturer or its authorised representative should notify the case by the most rapid means available and promptly follow up in writing (the parallel recall guideline phrases the same rule as 'within 72 hours'); where more than one company imported or distributed the affected devices in Ethiopia, each must report individually. The Field Safety Notice must include a clear title such as 'Urgent Safety Notice', a clear statement of the intended audience, company letterhead, use of a language or languages accepted by the Authority, and details identifying the affected product including model name and number, batch or lot or serial numbers and a factual statement of the reasons for the FSCA.

Where a regulated product is in contravention of applicable laws and its use or exposure will have adverse health consequences or would result in death, the responsible person may be ordered to recall their marketed products and to immediately cease distribution. The executive organ's administrative-measure powers separately authorise it to detain, seize, confiscate, order the disposal or recall of, or take other legal measures on a regulated product that does not comply with the proclamation, and to order the product seized, confiscated, disposed of or returned to its country of origin at the owner's cost where non-compliance is confirmed. The device recall guideline records that recalls are normally conducted voluntarily by the manufacturer or its authorised representative but that EFDA may also order a recall where the manufacturer or importer fails to recall voluntarily.

Before or upon initiating a recall, the manufacturer, its authorised representatives or importers must notify EFDA as per annex I, health professionals and the public for Class I recalls within 24 hours after identifying the problem or receipt of complaints for investigation and not to use it. If a non-conforming device poses a potentially significant hazard during weekends or public holidays, the manufacturer, its representatives or the user may immediately take precautionary measures to block or quarantine the device without notifying the Authority, but must notify the case within 72 hours by the most rapid means available, followed up promptly in writing. Class II and Class III recalls must normally be notified within 48 hours and 72 hours respectively. Where more than one company imported or distributed the affected devices in Ethiopia, each company must report individually. For the recall strategy, a factual timeline of within 24 hours to a maximum of 48 hours applies to Class I, up to a maximum of 10 days for Class II and up to a maximum of 20 days for Class III wherever necessary.

EFDA operates four device marketing authorisation routes. (1) Full assessment for all non-exempt devices that are neither low-risk listed nor SRA/prequalified: a complete dossier filed under GDL/097 (non-IVD) or GDL/087 (IVD). (2) The SRA/prequalified route under GDL/046 §9.4 for devices approved by a listed stringent regulatory authority or prequalified by WHO/UNFPA. (3) The low-risk route under GDL/092 for Class I non-IVD and Class A IVD devices on the published low-risk list, where EFDA permits abbreviated assessment or approval by notification procedure. (4) Devices on the 'Guideline for Importation of Medical devices Exempted from Registration' are outside registration altogether.

Once the inspection confirms that an applicant importer, exporter or wholesaler of medicines and medical devices fulfils the requirements, the Authority issues the certificate of competence within five working days. Sub-article 13 allows the Authority, in compelling circumstances and by notifying the applicant, not to issue the certificate within that period.

A regulated person who considers an administrative measure on its product or institution, or the denial of a legitimate service under the Proclamation, inappropriate, disproportionate or illegal may complain to the complaint handling organ within 30 working days of the final decision of the process owner or its confirmation by the higher official; the complaint may be brought directly if the higher official does not decide within 5 working days. The complaint handling organ must decide within 60 working days of receiving a complete complaint, and its final decision may be appealed to the court.

EFDA reviews an application for a special import (pre-import) permit for medicines and medical devices, submitted through eRIS, within three working days. The application must be lodged before the consignment arrives, and the permit granted is valid for one year unless the Authority extends it.

Notwithstanding the general prohibition on importing, manufacturing, storing, distributing, transporting, selling, holding, using or transferring an unregistered and unauthorised device, the executive organ may in compelling circumstances grant a permit for the importation or use of an unregistered medicine or medical device. This is the statutory basis of the special import route for unregistered devices; EFDA's implementing guidance cites it and Regulation No. 531/2023 Art. 5(10) as its legal basis.

An individual who wants to import medical products for personal use or a custom made medical device must have a prescription paper from an authorised health professional indicating the type, description and quantity of the medical products. In this case no pre-import permit application is required and the applicant can clear the product at the port of entry by showing the prescription paper. EFDA's pre-import permit rules state the same: pre-import permits are not required for medical products imported for personal use, including custom made devices.

EFDA does not require registration of medical devices intended to be used in four circumstances: custom made and personal use devices; devices for national health emergency; investigational devices; and devices for research, demonstration, training, education and other non-clinical uses. Devices in these categories must not be imported or placed on the market without EFDA's prior approval, and applicants are directed to the guideline for importation of medical devices through special access for that permission.

Where a device to be donated has been registered by EFDA, the recipient must liaise with the company holding the marketing authorization for the purposes of safety monitoring. Where the device is not registered in Ethiopia, EFDA permits importation of the donated product if the pre-import requirements in the donations guideline are complied with, so that EFDA can monitor the safety of the device while it is used in the country and, as applicable, test it. An applicant who wants to import or receive a medical device as a donation must hold a pre-import permit from the Authority, applied for through the eRIS system with the donor-recipient agreement, the recipient's certificate of competence or licence, a supporting letter from the Federal Ministry of Health or the regional or city administration health bureau, the device QMS certificate (ISO 13485) as appropriate, the proforma invoice, the donation certificate, the certificate of origin and, if applicable, the certificate of analysis.

The technical section of the registration dossier must list the standards complied with in full or in part in the design and manufacture of the device, giving at minimum the standards organisation, number, title, year/version and whether compliance is full or partial; for partial compliance the applicant lists the sections not applicable, adapted or deviated from, with a discussion. Conformity with the Essential Principles may be demonstrated by conformity with recognised or other standards, industry test methods, in-house test methods, pre-clinical and clinical evidence, or comparison to a similar marketed device.

The IVD registration dossier must list the standards complied with in full or in part in the design and manufacture of the device, stating at minimum the standards organisation, number, title, year/version and whether compliance is full or partial, and for partial compliance the sections not applicable, adapted or deviated from, with an accompanying discussion.

An application is rejected at screening or evaluation if the device is found not to fulfil the critical safety or performance parameters required in a relevant recognised standard, or if actual product samples requested for laboratory testing are not provided within six months of the request. EFDA may therefore request physical samples for laboratory testing as part of the review.

Applicants can request a review of a decision or appeal their complaints after a market authorization certificate is granted, in accordance with the complaint handling procedure set by the Authority. If an applicant wishes to request correction of a market authorization certificate, the request must be made within one month from the date of issuance of the certificate, and no certificate will be corrected if the request is made later than one month after issuance.

EFDA's device dossier assessment model is that the review is completed on the basis of the information submitted, a list of questions is then sent to the applicant setting a specified time limit for response, and a number of further rounds of assessment of the responses take place before a decision is made. An application is rejected at screening or evaluation if it is found to be unsatisfactory after evaluating the response to the third further information request, or if the applicant fails to respond to a request to fulfil required documents or information after screening or evaluation within 6 months from the date of the request. Rejection also follows if the requested actual samples for laboratory testing have not been provided within 6 months of request, if submitted documents are found fake or owned by another company, if the route of application is wrong (for example applying non-IVD as IVD or non-SRA as SRA), or if the device is already registered or another submission for the same device is pending by the same or another applicant.

The statute prohibits any person from importing or placing into use any medicine or medical device unless its labelling contains a barcode. This is a statutory labelling requirement and is the only express barcode obligation found for devices; it is separate from the UDI assignment and traceability duties in the GMP guideline.

The manufacturer must document traceability procedures covering at least the origin of the product, material and parts, the history of processing, distribution and the product location after delivery, and must define the extent of traceability and the records to be maintained. Where traceability is needed the manufacturer must establish a unique identification system for the product and maintain traceability records; it must require its distribution-service suppliers or distributors to maintain distribution records that allow traceability and are available for inspection, and the established traceability system must enable ease of product withdrawal from the market. Records required for traceability of implantable medical devices must include records of components, materials and work-environment conditions that could cause the device not to satisfy its safety and performance requirements.

Under the Ethiopian medical device GMP guideline the manufacturer's organisation must document a system to assign unique device identification to the medical device. The same clause requires documented procedures for product identification and for identifying product status against monitoring and measurement requirements throughout the manufacturing process, with records retained across the entire product lifecycle from production and storage to installation and servicing.

Once a manufacturer becomes aware that one of its devices may be associated with an adverse event or incident it must report to EFDA within the following deadlines: serious public health threat — immediately, and no later than 2 calendar days after awareness, with the adverse event reported within 48 hours by telephone, letter, email or in person and a written completed report within 15 days; death or serious incident — immediately, and no later than 10 calendar days after the date of awareness; other incidents — immediately after the manufacturer establishes a link between the device and the event, and no later than 30 calendar days after the date of awareness. Reports are filed as initial, follow-up and final reports, with the initial report possibly incomplete and supplemented later. Incidents occurring outside Ethiopia that lead to a field safety corrective action are also reportable. EFDA maintains separate guidance for field safety corrective action and field safety notices, product recall, and post-market surveillance.