🇷🇼 Rwanda medical device regulatory data

Rwanda FDA's promotion regulations apply to medical devices by definition: 'Regulated product' means processed foods, pharmaceutical products, vaccines, human and veterinary processed foods and other biological products used in clinical as drugs, food supplements, food fortificant, fortified foods, poisonous substances, herbal medicines, medicated cosmetics, 'medical devices', tobacco and tobacco products. Article 5 prohibits advertising, promoting or marketing any regulated product unless it is registered by the Authority, prohibits advertising or promoting any regulated product unless the advertisement or promotion has the clearance and approval issued by the Authority, prohibits carrying out a regulated product launch without prior written approval or clearance, prohibits promotion or advertisement that is directly or by implication misleading or calculated to mislead the population, requires packaging and labelling information consistent with the product information approved at registration, and requires all promotional materials to carry a disclaimer owning all claims stated in them as well as disowning third-party claims. Article 6 requires promotional advertisements to be accurate, unbiased, complete, clear and designed to promote credibility and trust by the general public and healthcare providers, to be consistent with the approved product information and in line with the conditions or illnesses for which the product was registered, and provides that promotional material shall not contain misleading or unverifiable statements or omissions regarding quality, safety and efficacy or value which likely induce product use or give rise to undue risks; promotion must not state or imply that a product is 'safe', is '100% safe', has 'no side effects' or that its 'use will not cause harm'. Article 7 prohibits promotion before written approval, restricts promotion to the public in open markets, bus stands and moving vehicles, treats posters in public places as promotional material targeting the general public requiring approval, and prohibits advertising words such as 'Number one product' or 'the best product'. Article 8 makes it an offence to promote, advertise or market any regulated product in a manner that is false, misleading or deceptive or likely to create an erroneous impression as to its character, value, quantity, composition, merit, safety or efficacy, and treats imitation of another company's advertisement layout, slogans or visual presentation in a misleading way as false and misleading. Article 11 requires the final version of the advertisement in whatsoever form to be submitted for vetting before final publication; acceptable advertisements are communicated in writing with the unique reference number issued by the Authority for each advertisement, unacceptable ones with written clarification, and alteration of the format without express written permission renders the approval null and void. Article 18 gives the Authority power to issue the guidelines, SOPs and forms necessary for implementation. The official application requirements require, among nine documents, 'Tangible or scientific proof or facts to back up claims made by the applicant (where applicable)', samples of all promotional materials in final versions, the product registration certificates for the products to be promoted and the degree of the responsible personnel who approved the message; and the official application form for approval of promotional materials (FDISM/PVSM/FOM/010) carries 'Medical Device [ ]' as one of its product-category options. Registration can be suspended where a registered device 'has been advertised in a manner which is false or misleading or does not comply with the provisions of the laws and regulations currently enforced by the Authority' (TRG/002 art. 24).

A certificate of full registration is valid for five years from issuance and may thereafter be renewed, subject to payment of prescribed annual retention fees. A certificate of notification is valid for three years. A certificate of conditional registration is valid for the period specified in the certificate, which may not exceed three years. Retention on the register is annual: an application for retention must be submitted one month before the due date, and the device is removed from the register if the application and fee are not effected. An application for renewal must be made at least 90 calendar days before expiry, with a grace period extending to 90 days after the expiry date; failure to renew within the grace period means the application is treated as new.

The Rwanda Food and Drugs Authority (Rwanda FDA) is a regulatory body established by Law No 003/2018 of 09/02/2018. One of its functions is to regulate matters related to the quality, safety and performance of medical devices including in vitro diagnostics in order to protect public health by increasing their access and availability. The law's Article 9 is the enabling provision for the technical regulations and guidelines, and Article 8 paragraph 15 gives the Authority the mission to build cooperation and partnership for harmonisation of practices with regional and international bodies.

Any variation to a registered medical device or IVD's information must be notified in writing to the Authority through an application in the approved format, as per the variation guidelines in force at the time of submission. A distinction is made between major and minor variations in accordance with those guidelines, with a difference in the applicable fees. An application for change on a registered or notified medical device is one of the submission types on the standard application form. Under the fee regulations, minor variations and annual retention are fee-waived, while a major variation of a registered product is charged at 50 per cent of the initial registration fee.

Medical devices are classified into four classes (A, B, C, D) based on the level of risk to the end user and their intended purpose. Class A is the lowest risk (examination gloves, tongue depressors) and Class D the highest (cardiac pacemakers, implants, IUDs); Class B is low-to-moderate (electronic thermometers, blood transfusion tubes, hypodermic needles) and Class C moderate-to-high (lung ventilators, condoms, infusion pumps). Where a device can be classified into more than one class the higher-risk class applies. Where one device is intended to be used together with a different device a separate submission must be made and conformity assessed separately. The manufacturer has the primary responsibility to classify its devices, but the Authority may challenge the classification and has the final say. The guideline also sets out detailed classification rules modelled on the IMDRF rules, covering non-invasive, invasive, active and special devices.

Registration of a medical device in Rwanda requires an overall clinical-evidence submission. ToC section 4.02 ('Overall Clinical Evidence Summary') requires a brief one-to-two page summary of the available clinical evidence presented in support of the submission, listing the evidence presented and its characteristics (RCT, case study, literature review, post-market data from another jurisdiction or from a marketed device) with a discussion of how it is considered sufficient to support the marketing request for the requested indications; a tabular listing of clinical studies may be included; where any study device differs from the device to be marketed, including a competitor's device, the applicant must describe those differences and their impact on the validity of the evidence, which may include a detailed comparison of the clinical, technical and biological characteristics of the two devices; and human factors testing that includes patients is filed here. Section 4.02.01 ('Clinical Evaluation Report') requires a clinical evaluation report reviewed and signed by an expert in the relevant field containing an objective critical evaluation of all clinical data submitted in relation to the device, together with a complete curriculum vitae or similar documentation justifying the manufacturer's choice of clinical expert. Section 4.02.02 ('Device Specific Clinical Trials') requires clinical-trial information grouped by trial, beginning with trial description, protocol number and date of initiation, followed by a clinical-trial summary and clinical trial report; raw data may be requested by the Authority (4.02.02.01.03). Section 2.07 ('Post-Market Study Plans') requires the applicant to provide post-market study plans, which may include clinical or non-clinical study plans, on study objectives, study design, subjects and sites, endpoints (primary and secondary), summary of the data-analysis plan, and length and frequency of follow-up, excluding final reports and analysis. Investigations on human subjects are regulated through the separate clinical-trial framework: art. 35 of TRG/002 provides that 'these regulations shall not apply to devices intended to be used in research and development studies, without prejudice to the provisions of the regulations on clinical trials in force', and the import/export guideline allows a special import authorisation for unregistered devices to be used in a clinical trial, on production of a clinical-trial approval certificate or ethical-committee approval/certificate (or, for veterinary research, approval from government institutions), with an application form FDISM/FDIEC/FOM/003.

The registration regulations apply to all regulated human and veterinary medical devices including in vitro diagnostics submitted for marketing authorisation, and they cover the full device groupings used by the Authority (single device, in vitro diagnostic, medical device group, medical device family, medical device group family and medical device system). All applications and supporting documents must be submitted in English, French or Kinyarwanda; where documents are in another language the applicant must submit translated copies to expedite review.

A registration application (as opposed to a notification) comprises a cover letter to the Director General, the registration application form, a technical documentation / technical file in Table of Contents (ToC) format, a declaration of conformity signed and dated by the manufacturer, copies of referenced literature and supporting documents, two commercial samples with a certificate of conformity where applicable, and a Rwanda FDA QMS audit certificate or proof of QMS audit application for Class C and Class D devices. The technical documentation must demonstrate conformity with the Essential Principles through a manufacturer-controlled EP checklist that identifies each applicable principle, the chosen method of demonstrating conformity and the reference of the controlling document. Submissions may be in any of the official languages. The declaration of conformity must state the manufacturer's information, the authorised representative where applicable, device information, risk classification, and a statement of conformity including applicable regulations or standards.

An application for registration or notification of a medical device or IVD is made to the Authority in writing by the applicant, the manufacturer or a Local Technical Representative. A Local Technical Representative (LTR) is any corporate body registered in Rwanda and authorised by Rwanda FDA to deal with medical devices and IVDs that has received a mandate from the applicant to act on its behalf in matters pertaining to registration. The submission must include a letter of authorization from the manufacturer authorising the LTR to submit the application, clearly highlighting the LTR's responsibility. The LTR is published against the registration in the register and on the Authority's website listing of registered devices.

Rwanda FDA guidelines reserve the importation of medical devices/IVDs to importers whose premises are licensed by the Authority or who fall within an eligible-importer category, and the eligible categories are exhaustively listed in section 1.1.2: (a) licensed manufacturers and wholesale companies of pharmaceutical and medical devices/IVDs; (b) licensed retail of pharmaceutical and medical devices/IVDs, only on medical prescription, where the product is not available on the market; (c) public and private health facilities; (d) hatcheries; (e) the beneficiary of a donation; (f) non-governmental organisations with a Memorandum of Understanding with the Ministry of Health or the Government of Rwanda; (g) government institutions and embassies; (h) UN organisations intervening in the health sector; (i) clinical-trial sponsors and principal investigators; (j) a tourist, a visitor in the country, or any other person for justified reasons. Section 1.1.1 adds the transactional conditions: all devices to be imported must be registered or granted special approval by the Authority; every import application passes through two mandatory phases, Visa then Licence; importation of a pharmaceutical product labelled for sale in a specified country is prohibited in Rwanda except where Rwanda is one of the specified countries; all applications for import authorisation must be submitted using a platform defined by the Authority; all consignments must pass through the approved port of entry and are subject to physical inspection at the port of entry or at the importer's premises (where released under seal) before being used. The underlying prohibition is in the registration regulations: art. 34 of DFAR/HMDAR/TRG/002 Rev_2 provides that 'No person shall manufacture, prepare, store, export, sell, dispense, distribute or import Medical Devices or In Vitro Diagnostics Devices unless the person must hold the appropriate certificate of registration or notification issued by the Authority.'

Under the Rwanda FDA tariff regulations (ODDG/RES/TRG/001 Version 5), registration and marketing authorisation of an imported machinery, medical equipment and device is charged at USD 100 where imported from the East African Community, USD 400 where imported from an SRA or WHO Listed Authority, and USD 600 where imported from other sources; the fee covers a five-year registration and includes a GMP inspection. A licence for a domestic manufacturing facility for medical equipment and devices is FRW 100,000 and includes the GMP certificate, manufacturing licence and registration/marketing authorisation. Notification of the registration of machinery, medical equipment and devices is fee-waived for both domestic and imported products. Annual retention and minor variations are also fee-waived. Foreign-manufacturer GMP inspections cover up to five production lines at one site, with additional lines charged at USD 400 each.

All medical devices including in vitro diagnostics intended to be marketed in Rwanda must be labelled in at least one of the official languages used in Rwanda; further detailed labelling requirements are set by the relevant guidelines. The device registration guideline's submission requirements include legible copies of the primary and secondary packaging labels, the package insert or instructions for use where required, e-labelling details where applicable (including the form of e-labelling, risk management, and how users are told in relevant languages where the IFU and further information can be found), healthcare-professional labelling and patient labelling. All information may be submitted in any of the official languages of Rwanda.

The legal basis is Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its mission, organisation and functioning, under which the technical regulations DFAR/HMDAR/TRG/002 Rev 2 'Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics' were made. Those regulations came into effect on 20 April 2020; Revision 1 of 8 June 2021 added the article on reliance, the article on emergency-use authorisation and the article on donation of medical products; Revision 2 of 22 August 2022 added IVDs as regulated products, added notification applications, and extended the regulations to veterinary as well as human devices. The operative guidance is DHT/GDL/024 Version 2 'Guidelines for Registration of Medical Devices' (November 2025), developed in reference to the Africa Medical Devices Forum, WHO and the International Medical Device Regulators Forum, together with the guidelines on submission of documentation for registration of IVDs.

Rwanda FDA imposes an explicit manufacturer-side post-market obligation chain. Section 5.5 of the safety and vigilance guideline provides that 'Manufacturers shall manage risks of their product throughout the entire lifecycle to monitor whether the risks continue to remain acceptable and whether any new hazards or risks of illness or injury associated with the use of the device for its intended uses and conditions of use are discovered. The risk management procedures shall be directly linked to the manufacturer's post-marketing surveillance procedures and shall focus on controlling and mitigating risks.', with the detail of risk-management activities as described in ISO 14971:2007. The same section requires manufacturers to plan and perform internal quality audits to verify that risk-management activities and results comply with planned and established procedures and to ensure the continued effectiveness of the risk-management system, requires risk-management activities to begin as early as possible in design and development, requires re-examination of the risk analysis and appropriate action whenever a risk is determined unacceptable, and requires that after release of the device to market 'risk management activities should be linked to quality management processes, for example, production and process controls, corrective and preventive actions (CAPA), servicing and customer feedback'. Section 5.5.1 requires a risk-management plan spanning the entire lifecycle of the device, containing scope of the plan, device and life-cycle phases, the design-development process, risk-management activities and methods, a verification plan for risk control measures, reviews, allocation of responsibilities and criteria for risk acceptability, together with the risk-management activities, the risk-analysis methods and the named analytical tools to be used. The registration regulations make failure to report a suspensive ground: 'The Authority may suspend registered devices if it is satisfied that: […] The marketing authorization holder has failed to submit periodic post-marketing surveillance reports; The marketing authorization holder, intentionally and without justifiable reasons has failed to submit reports on adverse effects, and the renewal of registration has defaulted beyond the specified grace period' (TRG/002 art. 24). The registration dossier must contain post-market study plans where applicable (DHT/GDL/024 Version 2, section 2.07).

An application for registration or notification of a medical device is received only through the Rwanda FDA online portal; applications and queries are handled there, and a reference number is assigned on receipt and used in all subsequent correspondence. Where samples are required, they are delivered to Rwanda FDA headquarters reception with the cover letter and a printed email notification bearing the application reference number generated at submission. The application forms are the appendices to guideline DHT/GDL/024: Appendix 1 cover letter, Appendix 2 notification application form, and Appendix 3 device registration application form.

The QMS audit is part of the medical device registration process. All Class C and Class D devices must apply and pay the relevant QMS audit fees, and the Authority must inspect the manufacturing facility or use other means to verify QMS compliance before the device is registered, unless the device is under the abridged assessment procedure, in which case QMS compliance of the manufacturing site is confirmed through desk review. The Authority reserves the right to conduct a QMS audit for other classes where regulatory review or technical assessment indicates the necessity, and may conduct an on-site inspection of an abridged-assessment device if deemed necessary. Registration applications for Class C and Class D must include a Rwanda FDA QMS audit certificate or proof of a QMS audit application; for notification, a valid ISO 13485 certificate or equivalent is required. Under the fee regulations the registration fee for an imported device includes a GMP inspection covering up to five production lines at one site.

Rwanda FDA treats field safety corrective action and recall as reportable and enforceable post-market events. The safety and vigilance guideline requires that 'Field Safety Notices (FSN) and Field Safety Corrective Actions (FSCA) including those based on incidents occurring outside Rwanda must be reported to Rwanda FDA' and that 'manufacturers must report field safety corrective actions for marketed products'; the status of any FSCA or FSN must also be included in periodic summary reports. The Authority's regulatory actions are listed in section 13.1 and expressly include urgent safety restriction, variation, suspension and revocation of the marketing authorisation and, at item i, 'Product recalls'; where a product is seriously or persistently non-compliant the Authority may also inspect, issue a formal warning letter and publish a list of non-compliant stakeholders. Section 13.3 governs withdrawal: after a risk-benefit evaluation shows the risks outweigh the benefits and the proposed risk-minimisation measures are considered inadequate to redress the balance, the medical product should be withdrawn from the market and healthcare professionals and patients/the public informed as appropriate; where the MAH withdraws the product due to safety concerns it is obliged to report immediately to Rwanda FDA. The dedicated recall guideline supplies the operative mechanics and expressly covers devices at the level of its definitions: 'Regulated product' means … 'human and veterinary medical devices', and 'Statutory recall' refers to when the Authority requests or orders a product recall due to non-compliance to regulatory requirements. Recall classification drives depth: Class I recalls are executed to wholesale/distributor, retail and consumer levels with public announcements via print/electronic media, newspapers, television and radio, Class II to wholesale and retail levels, and Class III to wholesale level. The timelines table applies to the initiation and stopping of sale/distribution of the defective product: Class I 24 hours initiation and 72 hours physical recall, Class II 48 hours and up to 10 days, Class III 72 hours and up to 30 days. Section 3.15 requires that after recall the recalling entity, immediately on becoming aware of the problem, notify the Authority in writing with defined recall information including the product identification, batch numbers, manufacturing and expiry dates, total quantity imported or manufactured and the quantity originally in the recalling company's possession.

Rwanda FDA processes medical device applications through three routes. Notification applies to Class A devices that are non-sterile, non-active and without a measuring function, and results in a certificate of notification. Registration applies to all other devices and is assessed either through the abridged assessment procedure, where prior assessment and inspection outcomes from WHO prequalification or a competent NRA are taken into account, or through full assessment, which is a two-assessor scientific and regulatory review of quality, safety and performance. Applications are submitted through the Rwanda FDA online portal. Priority assessment may be granted where the device is intended for diagnosis, treatment or alleviation of rare disease conditions, or in an emergency situation.

Rwanda FDA commits to processing applications within 20 working days for the notification procedure, 60 working days for the abridged assessment procedure, and 180 working days for the full assessment procedure. Additional data must be submitted within 10 working days for notification, 20 working days for abridged assessment, and 60 working days for full assessment. Dossiers are scheduled for assessment on a first-in-first-out basis. The reliance pathway for marketing authorisation under the reliance guideline is stated to take 90 working days excluding clock stops. For lower-risk medical devices the registration timeline may be significantly shortened.

The Authority may issue an authorisation for emergency use when a national public health emergency has been declared and the device meets one of the listed requirements: it is listed as prequalified or has been granted emergency use authorisation by the World Health Organization or the World Organisation for Animal Health; it is registered or has been granted emergency use authorisation by Stringent Regulatory Authorities; it is registered or granted emergency use authorisation by countries having collaborative agreements with the Authority; or the normal device registration process is ongoing and the Authority decides to grant emergency use authorisation based on the severity of the declared public health emergency. The emergency authorisation is issued following approval of the registration of the device under Article 17 as a certificate of emergency registration. A parallel article permits emergency use of an unregistered medicinal product or an unapproved use of a registered medicinal product.

Rwanda gives an express, timed appeal against a decision of the Authority. Article 37 of the registration regulations provides: 'Any person aggrieved by a decision of the Authority may appeal to the Authority for review of the decision showing grounds for dissatisfaction within thirty (30) calendar days from the date of notice. The Authority shall, within forty-five (45) calendar days from the date of receiving the application, review, reject or uphold its own decision according to applicable laws, and regulations. The applicant shall not be barred from appealing to the minister/ board of directors without applying to the Authority for review. If a person is dissatisfied with the decision after review, he/she may appeal to the supervising Authority whose decision shall be final.' The communications that precede an appeal are also codified. During assessment the Authority may request additional samples, documents, information, data or clarification; processing does not proceed until they are provided; failure to provide them within ninety (90) days of the date of request makes the application considered withdrawn; the applicant may request an extension of time in writing with reasons; and a fourth failure to provide satisfactory responses leads to rejection (art. 11). Where the Authority refuses to issue or amend a certificate of registration or notification it must notify the applicant in writing of the reasons for the refusal (art. 30), and any suspension must be effected on written notice setting out the reason for the proposed suspension, any corrective action required and the time within which it must be taken, and requiring the holder to show reasons in writing with evidence as to why the suspension should not be effected (art. 25). A holder may apply in writing to have a cancellation or suspension uplifted, and the Authority may review its decision within thirty (30) days of receiving the application (art. 27). The promotion regulations give a parallel route: an aggrieved person may apply to the Authority for review showing grounds for dissatisfaction within thirty (30) working days from the date of notice, the Authority must within fifteen (15) working days review, reject or vary its own decision, and if it still rejects the application the applicant shall appeal to the Board of Directors (CBD/TRG/017 Rev_1 art. 21). The vigilance guideline gives MAHs a written appeal against suspension or cancellation of a marketing authorisation within thirty (30) calendar days from the date of the Authority's notification; the grounds must be based on the information already submitted in the product's dossier and PSMF, additional or new information not earlier submitted will not be accepted, and the Authority may review or uphold its earlier decision (section 13.5).

Three linked devices exist. First, the registration dossier must carry a 'Listing of Device(s)': 'Where applicable, a table listing each variant/model/configuration/component/accessory that is the subject of the submission and the following information for each variant/model: a) the identifier (e.g. bar code, catalogue, model or part number, UDI) b) a statement of its name/description that provides (e.g. Trade name, size, material)' (DHT/GDL/024 Version 2, section 1.05). The guideline thus requires a UDI-or-equivalent identifier as the listing key but does not mandate a UDI carrier or a UDI database. Second, approval is a registration event: on approval the Authority must enter in the register the prescribed particulars of the device, allocate a registration number and issue a certificate of full, conditional or emergency registration or of notification (TRG/002 art. 17), and must publish a list of registered devices on its website including the brand/generic name and model, the registration number, the intended purpose, the marketing authorisation holder and its country, the original manufacturer and its country, the registration date and status, the class of the device, the device nomenclature code allocated to the device, the local technical representative, and the expiry date of the certificate (TRG/002 art. 18) — so the registration number and the nomenclature code are the public device identifiers. Third, post-market traceability is risk-driven: the manufacturer must use its risk-management data to define which devices, components, materials and work-environment conditions require traceability and to establish the traceability criteria, the points to be considered being origin of components and materials, processing history, distribution and location of the device after delivery (to the first consignee), intended use (life sustaining, life supporting or implantable), probability of failure, need for safety-related updates (recalls, advisory notices, field updates) and consequence of the failure for patients, users or other persons; the traceability records must cover all such devices, components, materials and work-environment conditions that could cause the device not to satisfy its specified requirements including its safety requirements (FDISM/PVSM/GDL/002 Rev 02, section 5.5.4).

Rwanda FDA's safety and vigilance guideline imposes the incident-reporting duty affirmatively and in terms: 'In addition, anybody can report incidents; however, healthcare professionals and manufacturers as well as MAHs, distributors and importers of medical devices are obliged to report incidents. Moreover, manufacturers must report field safety corrective actions for marketed products.' The reportable event is defined: an event or incident including a malfunction or deterioration in the characteristics or performance due to a medical device must be reported if it meets stated criteria (for IVDs, false positive or false negative results where an erroneous result would lead to an imminent life-threatening situation or cause death or severe disability to the individual tested, the foetus or the individual's offspring, and for other IVDs false positives or negatives falling outside the declared performance of the test), with named event categories (unexpected adverse reaction or side effect; interactions with other substances or products; degradation or destruction of the device; inappropriate therapy; inaccuracy in labelling, instructions for use and/or promotional materials, including omissions and deficiencies; and the device being considered a contributing cause of the incident) and named outcomes (death of patient, user or another person; serious deterioration in state of health including life-threatening disease or illness, permanent damage or impairment of a body function, necessary medical or surgical treatment to prevent life-threatening illness or permanent injury, indirect harm from incorrect diagnostic or IVD test results or from IVF/ART equipment used per the IFU, and foetal death, foetal injury or congenital abnormalities). Any incident, whether the fault lies in technical faults or defects in the equipment, instruction manual, marking, use or maintenance, must be reported, and events due to the intervention of healthcare professionals must be reported regardless of serious outcome. A trend duty sits on top: on identifying a significant increase or trend of events usually excluded from individual reporting, the manufacturer or the MAH must report to the Authority, and the manufacturer should have suitable systems for proactive scrutiny of trends in complaints and incidents. Field Safety Notices and Field Safety Corrective Actions, including those based on incidents occurring outside Rwanda, must be reported to Rwanda FDA. The timelines for incidents occurring in Rwanda are: serious public health threat — immediately, and not later than 24 hours after awareness; death or unanticipated serious deterioration in state of health — immediately after the manufacturer has established a link between device and event, and not later than 10 elapsed calendar days following awareness; others — immediately after the manufacturer has established that link, and not later than 30 elapsed calendar days following awareness. Six conditions where reporting is not required are specified, and periodic summary reports must include the full details of vigilance issues including the status of any FSCA or FSN. All adverse events related to medical devices must be reported to Rwanda FDA using the suspected adverse event/incidence reaction reporting form No. FDISM/PVSM/FOM/015.