Vigilance & incident reporting by country

Any natural or legal person placing devices on the market or putting them into service must inform AKBPM of every adverse event concerning: (a) any malfunction or deterioration of the device's characteristics and/or performance, and any inadequacy of the labelling or instructions for use, that led or could lead to the death of a patient or user or to serious deterioration of their health; (b) any technical or medical reason relating to device characteristics or performance leading to systematic withdrawal from the market by the manufacturer of devices of the same type. AKBPM records and evaluates the information and notifies the responsible structure, which ensures the manufacturer or its Albanian representative is informed; the reporting procedure and format are set by order of the minister responsible for health.

ANPP must act when a pharmaceutical product or medical device presents, or is suspected of presenting, a danger; its missions include quality control and expertise of devices, inspection of sites against device norms, and suspension of homologation decisions.

Tecnovigilancia submissions must be processed through the ANMAT digital platform available for that purpose (ARGOS, the ANMAT system for adverse event and field safety corrective action reports).

Field safety corrective actions (FSCA) must be reported to ANMAT within 10 calendar days counted from their implementation.

Any serious threat to public health must be reported within 48 hours; incidents involving death or serious deterioration of health must be notified within 10 calendar days of becoming aware.

The Expert Organisation analyses the collected data on adverse effects and events (incidents) of medical devices and submits an expert conclusion to the authorised body so that the corresponding decisions can be taken, and it keeps a register of adverse events detected during the use (operation) of medical devices. Where facts concerning the safety, quality and effectiveness of a medical device are detected, the Expert Organisation informs the manufacturer of the device or its authorised representative and, where necessary, requires additional information from them. Healthcare professionals are obliged to inform the authorised body in writing and in a timely manner, in the established procedure, of adverse events involving medical devices.

When the importer receives written complaints about undesirable events connected with a medical device it has placed on the market, it must pass that information immediately to the authorised body (Ministry of Health) and also to the manufacturer or the manufacturer's authorised representative, in accordance with the rules approved by EEC Board Decision No. 174 of 22 December 2015. The importer also keeps registers of complaints, of products not complying with the legislative requirements and of recalls, and provides the manufacturer, its authorised representative or the supplier with the requested information to clarify complaint related problems.

It is an automatic condition of ARTG inclusion (cl 5.7, Part 5 Div 5.2 of the MD Regulations) that sponsors report adverse events and near adverse events to the TGA via IRIS; all adverse events for devices supplied in Australia are required to be reported.

initial: 48 hours for a serious threat to public health; 10 days for death or a serious deterioration; 30 days where an event might have led to death or serious deterioration · final: final report within 120 calendar days of the initial report · follow up: follow up information at least every 30 calendar days · channel: MDIR application in TGA Business Services; only Australian events are reportable, overseas remedial actions go to the TGA recalls team

Where there is suspicion of falsification of a medical device, this must be reported to BASG immediately (unverzüglich); devices involved in incidents must not be destroyed but must be subjected to a root cause analysis.

Until EUDAMED is fully functional, manufacturers and authorised representatives must report serious incidents and field safety corrective measures in Austria by email to medizinprodukte@basg.gv.at (based on the MDCG 2021 1 guide and § 2 Elektronische Einreichverordnung 2011), using the European agreed reporting forms (MIR form 7.3.1, submitted as .xml and .pdf); users and physicians may report via the online form at tforms.basg.gv.at/meldung medizinproduktevorfall.

Members of the regulated health professions and persons who commercially or professionally operate or use medical devices must report to BASG immediately (unverzüglich) every serious incident (schwerwiegendes Vorkommnis) that becomes known to them, together with all observations and data relevant to medical device safety; the manufacturer or authorised representative must also be informed; in hospitals reports run uniformly via the medical director unless immediate danger exists; the duty also applies to further making available on the market.

The Ministry suspends the state registration of a registered medical device where, apart from the cases in Article 25 of the Law on Licences and Permits, it is established that: the benefit/risk assessment under the Pharmacovigilance Rules (Cabinet Resolution No. 503 of 25 December 2019) shows the therapeutic efficacy to be absent or insufficient; packaging and labelling requirements are not complied with after an official warning from the Analytical Expertise Center has been disregarded; or substantiated facts establishing that the registered product is not quality, effective and safe lead to a decision prohibiting its use in Azerbaijan. Suspension stops import, manufacture for sale, sale and use, and a recall decision is then taken under the Recall Rules approved by Cabinet Resolution No. 460 of 27 November 2019.

Adverse events associated with a medical device are reported to NHRA on the Medical Devices Reporting form. Death or serious injury must be reported within 10 working days and other problems not associated with high risk or injury within 30 working days, by manufacturers, authorized representatives/suppliers and healthcare facilities alike; reports must be submitted immediately and fully. NHRA reviews reports, may request further information and may consult other authorities.

Serious adverse events must be analyzed and reported as vigilance reports to the designated authority in DGDA within 10 working days from the date the incident becomes known to the manufacturer/importer.

Manufacturers, importers and marketing companies, hospitals, clinics, public health programme institutions and other stakeholders must mandatorily conduct pharmacovigilance activities for monitoring adverse drug reactions in humans or animals and send related reports and data to the Licensing Authority.

Circulation subjects must notify RUP CEIZ of an adverse event (incident) using the prescribed form (извещение) within 20 calendar days of the event; where there is a serious threat to user health, immediately but no later than 2 working days. After a confirmed incident the producer (or its authorized representative) must submit an incident report (отчет) within 30 calendar days of receiving/sending the notification, or within 2 working days for serious threats.

Failure of the producer (or its authorized representative) to report an adverse event (incident) to RUP CEIZ, or breach of the prescribed procedure/deadlines, is a ground for the Ministry of Health to suspend the registration certificate (or individual registration numbers); RUP CEIZ informs the Ministry of such facts within 3 working days.

Hospitals must create an internal materiovigilance contact point, notify its details to FAMHP, and FAMHP publishes the list of materiovigilance contact points on its website. The obligation was introduced by the Royal Decree of 15 November 2017 (in force 17 December 2017) and is codified in the Law of 22 December 2020.

FAMHP operates national notification forms: users outside care settings and care settings (hospitals, rest homes) complete the national notification form (French PDF), routing principally via the materiovigilance contact point; distributors use a dedicated distributor notification form; manufacturers and authorised representatives use the European Commission forms (incident notification, docsroom 41681; FSCA notification, docsroom 32305). Completed forms go to the FAMHP Vigilance division (Galileelaan 5/03, 1210 Brussels), by post, fax or email (vigilance.meddev@fagg afmps.be).

Under the Law of 22 December 2020, health professionals and professional users are required to notify serious incidents linked to a device to FAMHP (via the AFMPS website form); professionals working in a hospital report instead to the local materiovigilance contact point.

statement: AGEMED may cancel the Registro Sanitario of a medical device during its term at the request of the interested party after evaluation, where substantial changes are found in the approved parts and components that were not notified, or where after a review of alerts AGEMED resolves by minute to issue a cancellation resolution. The National System for Vigilance and Control of Medicines applies to medical devices for these purposes. · article: Numeral 5.11

statement: When a Registro Sanitario is cancelled, the withdrawal of the product from the market is set according to the severity in health terms, under the responsibility of the company, within 72 hours, three months or nine months, as the case may be. · article: Numeral 5.11.1

Manufacturers, distributors and health institutions are obliged to report to the Agency every observed undesirable or harmful effect caused by medical devices, in accordance with the conditions prescribed by the Ordinance on Medical Devices and the Act.

The provisions of Article 72(1) of the Act relating to pharmacovigilance apply correspondingly to medical devices, that is to the materiovigilance procedure. The manner of and procedure for reporting undesirable occurrences during the use of medical devices, the manner of responding to them, the obligations of medical staff and suppliers, and the organisation of the system for monitoring undesirable occurrences are prescribed by the Expert Council on the proposal of the Director of the Agency.

It is the responsibility of all manufacturers and healthcare professionals to report medical device adverse events (MDAEs), with importers and distributors forwarding incident reports to the primary manufacturer. For marketing authorisation holders the timelines are: serious public health threat events within 48 hours after first knowledge by the manufacturer; death or serious adverse events within 10 calendar days; and all other adverse events, non serious, suspected and unexpected, within 30 calendar days. BoMRA may agree to exempt common, well documented events from reporting or convert them to periodic or summary reporting.

Under RDC 67/2009 Art. 8º (consolidated text, as amended): death, serious threat to public health, or counterfeiting associated with a product registered in the holder's name must be reported within 72 hours (corridas); other occurrences, including serious adverse events not resulting in death and technical complaints with potential for death or serious adverse event, within 10 days (corridas); technical complaints within 30 days; events occurring abroad involving foreign registered products within 10 days.

Section 74 of the Medicines Act requires a licensed manufacturer, wholesaler, importer or product licence holder to notify the Authority immediately of any adverse reactions arising from the use of the registered medicinal product. The Act read in full contains no adverse event, incident or malfunction reporting duty for medical devices or IVDs, and no timeline or form for such reports exists.

Brunei's Pharmacovigilance Guidelines adopt the Medicines Order, 2007 s. 4 definition of 'medicinal product', which excludes 'an instrument, apparatus or appliance', and require licence holders to report serious adverse drug reactions to the National Adverse Drug Reaction Monitoring Centre no later than 7 calendar days after first awareness, with follow up within 8 additional calendar days. The Guidelines contain no device incident reporting provision.

Within three months of filing the initial report under Art. 106, the manufacturer must prepare and submit to BDA a final report on the form approved by the Executive Director.

The manufacturer must file with BDA an initial report on the official form within 10 days of receiving information about an incident that caused death or serious deterioration of health, and within 30 days for potential incidents; incidents involving third country devices are also reportable.

Under the ASEAN framework binding Cambodia, anyone responsible for manufacturing or placing a device on the Cambodian market must keep traceability records and produce them for inspection, and must inform the regulatory authority, within the time and format it prescribes, when they become aware of any adverse event that has arisen or can arise from use of the device placed on the market, and when they perform or intend to perform a field safety corrective action on such a device.

A licence holder (or importing MDEL holder) must notify Health Canada of a decision or action by a foreign regulatory agency, from the List of Regulatory Agencies incorporated by reference, concerning a serious risk of injury to human health, within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

Manufacturers and importers must report incidents to the Minister in a preliminary report within 10 days after becoming aware of an incident that caused death or serious deterioration of health, and within 30 days where death or serious deterioration could result if the incident recurred; incidents outside Canada are reported as soon as possible once corrective action is intended or required by a foreign agency.

Mandatory problem reporting runs through Health Canada's Canada Vigilance Medical Device Problem Reporting Program; the Medical Device Foreign Risk Notification form (listed 2022 06 10) is used for s.61.2 notifications, and a separate medical device problem report form exists for health care professionals.

Public or private health institutions using devices governed by D.S. N°825/1998 must communicate to ISP any defective behavior, failure or deterioration of characteristics or functioning, as well as missing label or instructions for use information that directly or indirectly could or could have led to a patient's or user's death or health deterioration.

seriousEventsOrSentinel: As soon as possible and no later than 3 working days (días hábiles) from becoming aware · adverseEvents: As soon as possible and no later than 30 working days · incidentTrends: Adverse incidents showing increased occurrence: no later than 30 days after analysis/validation by the tecnovigilance responsible

Notifiable adverse events are those that harm the patient or user of the device (e.g., device malfunction when used as intended causing temporary harm). ISP's notification system uses four forms on its website: ANDID/006 (health care providers), ANDID/008 (legal manufacturer, authorized representative or importer), ANDID/010 (DMDIV associated events) and ANDID/012 (FSCA communication), sent by the responsible tecnovigilance officer to tecnovigilancia@ispch.cl; providers also send complete forms to their Servicio de Salud and to the manufacturer/importer/representative. Non notifiable situations include expected/probable occurrence and events associated with abnormal use of the device.

Group (群体) adverse events must be reported within 12 hours by phone/fax to the provincial drug regulatory and health departments where the event occurred, with basic information entered in the national monitoring system and each individual case reported within 24 hours; the holder must immediately suspend production and sales, notify user units to stop use, investigate, run a QMS self inspection, and report to both provincial authorities and monitoring institutions within 7 days.

Reporting follows the report if suspicious (可疑即报) principle: events that led or may lead to serious injury or death must be reported (innovative devices: all events in the first registration cycle). Individual deadlines: fatal events within 7 days; serious injury or possible serious injury/death within 20 days; events occurring overseas known to the holder within 30 days; evaluation results reported to the provincial monitoring centre within 30 days (death) or 45 days (serious).

Reports are filed through INVIMA's tecnovigilancia web aplicativo (farmacoweb.invima.gov.co/TecnoVigilancia), requiring role based registration; serious events use the FOREIA module and quarterly non serious mass reports use the RETEIM format; report forms must contain the minimum fields of Resolución 4816 de 2008.

Serious adverse events and incidents (EVENTOS/INCIDENTES ADVERSOS SERIOS) must be reported to INVIMA within 72 hours of occurrence, with the report content set by Article 14 of Resolución 4816 de 2008.

Manufacturers and importers of devices, health service providers, independent professionals, users and any person with knowledge of an adverse event or incident must report it to the corresponding instance of the Programa Nacional de Tecnovigilancia; separately, the registration/permit titular, manufacturer or representative and users must notify INVIMA of all adverse incidents and incorrect or improper use.

Information on all adverse event and incident reports (serious and non serious) must be presented quarterly in consolidated form by the manufacturer's, importer's or distributor's tecnovigilance responsible to the local Áreas Rectoras de Salud, regional Direcciones Regionales de Rectoría de la Salud, or the CNTV, including preventive/corrective measures proposed or executed; non serious events are reported quarterly by the designated responsible. Failure to report leads to a sanitary order (orden sanitaria) and, if not complied with, cancellation of the sanitary registration.

Serious adverse events and incidents (those that may lead to or endanger life or cause serious deterioration of health, including life threatening disease or injury, damage to bodily function or structure, conditions requiring medical/surgical intervention to prevent permanent damage, incapacitating events) must be reported to the CNTV within 24 hours of occurrence or from the moment knowledge is obtained.

The manufacturer, the importer/exporter and the distributor must each immediately inform and place at the disposal of the competent authorities (in Côte d'Ivoire, the AIRP) every report of an adverse event concerning a medical device that they receive or hold after investigation, together with the safety corrective measures implemented. The harmonised text fixes no numerical reporting deadline: the duty is expressed as 'immediately'. Reportable event definitions: an 'adverse event' is any unintended medical incident, illness or injury, or any unintended clinical sign, including an abnormal laboratory result, in subjects, users or other persons in the context of a clinical performance study, whether or not linked to the device; a 'serious adverse event' is one causing death; a serious deterioration in the subject's health (life threatening illness or injury, permanent impairment of the body or bodily functions, hospitalisation or prolongation of hospitalisation, or medical or surgical intervention to prevent such); or foetal distress, foetal death or a congenital abnormality or anomaly.

HALMED conducts vigilance for medical devices and in vitro diagnostic medical devices in accordance with the MDR and IVDR. Economic operators report their knowledge of adverse events under those regulations; healthcare workers, users and patients report adverse events connected with devices directly to HALMED, and HALMED keeps a record of all reports received from healthcare workers, users and patients. The Ministry and HALMED take measures to encourage such reporting.

A manufacturer must report any serious incident immediately after it has established, or considers reasonably possible, a causal relationship between the incident and its device, and not later than 15 days after becoming aware of the incident. In the event of a serious public health threat the report must be provided immediately and not later than 2 days after the manufacturer becomes aware of the threat. In the event of death or an unanticipated serious deterioration in a person's state of health the report must be provided immediately after the manufacturer establishes or suspects a causal relationship, and not later than 10 days after becoming aware of the incident. Reports are submitted through the electronic system referred to in MDR Article 92.

CECMED, through the Programa de Reporte Usuario REM, monitors adverse events related to medical equipment and devices; upon an adverse event it must be notified using the adverse event reporting form (Modelo de Reportes de Eventos Adversos). Reports reach the equipment vigilance unit at centinelaeqm@cecmed.cu (phones +53 7 2164364/2164365). CECMED publishes alerts typed as Alerta de Seguridad, Comunicación de Riesgo and Comunicación del Fabricante.

As an inscription requirement, suministradores must present a declaration of documented procedures (with code and title) to carry out in Cuba: reporting of adverse events per CECMED regulations; follow up of devices in use in the SNS; communication of field safety notices (notas de aviso) issued by the manufacturer; communication of market withdrawals (retiros) carried out by the manufacturer; customer feedback; and supplier evaluation.

Manufacturers have the responsibility of informing the competent authority of every serious adverse incident relating to a product bearing their name, by completing and sending CYMDA the appropriate form (Manufacturer incident report 2020). CYMDA directs readers to Chapter VII of Regulations (EU) 2017/745 and 2017/746 for the reporting procedure and for post market surveillance.

Suppliers of medical devices and in vitro diagnostic devices are required under Article 13(6) / Article 14(5) of Regulation (EU) 2017/745 and the corresponding provisions of Regulation (EU) 2017/746 to keep records of complaints, to inform the manufacturer and to provide any useful information at the manufacturer's request. CYMDA states that managing the incidents, problems and complaints arising from the use of the devices they supply is therefore an obligation of suppliers.

Healthcare professionals may report incidents, problems or complaints arising from the use of medical devices and in vitro diagnostic devices to CYMDA by two channels: completing the attached Medical Devices Adverse Incident User Report Form and sending it to cymda@mphs.moh.gov.cy, or completing the Microsoft Forms electronic form linked from the notice. CYMDA recommends that users also report every incident, problem, complaint or event relating to a device to the manufacturer, directly or through the supply chain.

SÚKL retains all information on serious incidents in the Czech Republic and on field safety corrective measures for 15 years; where a serious incident involved injury or death of a user, patient or other person, retention is 30 years. Reports of suspected serious incidents received from users are retained for 10 years.

SÚKL publishes manufacturer incident report forms (MIR) for MDR/IVDR serious adverse events: initial report, follow up report, combined initial and final report, final report (reportable event) and final report (non reportable event), each in Czech and English; the underlying EU form is the New Manufacturer Incident Report (MIR) Form v7.2.1 (January 2020). Online e forms are at formulare vigilance zp.sukl.cz/mir/.

Healthcare providers and patients have no statutory duty under Act 375/2022 Sb. to report suspected serious incidents to SÚKL; a patient may voluntarily report a suspected serious incident (e.g. death, health deterioration, serious threat to public health) to SÚKL by data box (ID qwfai2m), e mail urgent@sukl.gov.cz or posta@sukl.gov.cz, or post (Oddělení vigilance, Šrobárova 48/49, 100 00 Praha 10); urgent@sukl.gov.cz runs an off hours duty service (working hours Mon Fri 8:00 16:30). A provider suspicion e form (P05) is also published.

When a serious incident occurs or is suspected, a healthcare provider must: take all measures to minimise the incident's negative impacts; make the device and all documentation available to the manufacturer and SÚKL for inspection and cause analysis; and provide full cooperation and information. A provider suspecting a serious incident with injury or death must record this in the patient's medical documentation.

The Danish Medicines Agency may in special cases decide that the incident reporting duty extends to any incident with a specific type of device or IVD that could cause or could have caused any form of injury to a patient, user or third party; DKMA publishes a list on its website of the devices/IVDs for which manufacturers must report every incident.

Operators of public and private hospitals must immediately ('straks') report to the Danish Medicines Agency any incident with a device or IVD that could cause or could have caused death of a patient, user or third party, or serious deterioration of health; the duty applies correspondingly to authorised health professionals practising independently outside the hospital system and others who use devices in the course of their occupation. Citizens (users, patients, relatives) may also report.

DKMA guidance sets risk based deadlines for manufacturers reporting incidents to the Danish Medicines Agency: immediately and no later than 2 calendar days for incidents constituting a serious threat to public health; immediately and no later than 10 calendar days for deaths and unexpected incidents (not included in the risk analysis); immediately and no later than 30 calendar days for other incidents (included in the risk analysis) — counted from the manufacturer's awareness of the incident. Near misses averted by intervention are also reportable.

A manufacturer of a device placed on the market must report serious incidents under MDR Article 87(1)(a) to the Danish Medicines Agency when the incident occurred in Denmark; the manufacturer must send the final report of the incident investigation (MDR Art 89(5)) and every notice of a field safety corrective action under MDR Article 87(1)(b) to DKMA. Corresponding duties apply to IVD manufacturers under IVDR Article 82(1)(a)/(b) and Article 84(5) (report to DKMA for incidents occurring in Denmark).

Healthcare professionals report device incidents via the DKMA portal (portal.dkma.dk/indberetningmusundhedsperson); citizens, users, patients and relatives via portal.dkma.dk/indberetningmuborgerpaaroerende; manufacturers report serious incidents using the EU Commission MDCG vigilance/post market surveillance reporting forms, which per DKMA guidance are sent to the Danish Medicines Agency (med udstyr@dkma.dk). Authorised representatives, importers and distributors must immediately report suspected serious incidents to the manufacturer and may also report to DKMA.

statement: Under the Ley General de Salud, importers, manufacturers and health professionals are obliged to communicate the adverse effects caused by medicines and other sanitary products whenever a danger to life or health may derive from them, or where the therapeutic effect proves invalid or fails to produce the expected effects. DIGEMAPS has strengthened post market surveillance so that any adverse event on a medical device is identified and managed quickly. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

Written notification to the UZTV and/or CNTV is due: within 48 hours of confirmation for a serious public health threat; within 10 days for death or serious (temporary or permanent) deterioration of a patient, user or other person; within 30 days for other reportable events. The final follow up report to the CNTV is due within six months maximum depending on severity, extendable once for an additional equal period on request.

The manufacturer and/or registration holder must investigate each adverse event, establish the causal relationship between the device and the event, and produce an initial investigation report, a follow up report and a final report in ARCSA formats; the investigation must include a risk evaluation stating whether corrective and preventive actions are needed, which are notified to the CNTV. The CNTV may intervene or open an independent investigation and request information as often as needed.

An adverse event is reportable to the CNTV when three criteria concur: (1) an event occurred in Ecuador with an authorized device (malfunction in intended use, unforeseen events, labeling/instruction inaccuracies, false results causing misdiagnosis, undeclared temporary harm, interactions, design failures discovered on review, serious public health threat, use errors, new literature information); (2) the device is related to the event; (3) the event led or could lead to death, serious injury or serious deterioration of health. Exempt events (defect found before use, patient condition, shelf life expiry, protection worked, negligible probability, expected/foreseeable events, events described in warnings, CNTV granted exceptions) are communicated only to the registration holder; trend changes or frequency increases must be notified.

Notifications to the National Technovigilance Center are made in the formats established by ARCSA on its website and sent by email to tecnovigilancia@controlsanitario.gob.ec or through the virtual platform ARCSA uses for the purpose; reporting formats follow PAHO/IMDRF guides and reference/high vigilance agency annexes. Confidentiality of patient and notifier data is mandatory.

At registration/re registration the importing company must submit a commitment that it operates a device vigilance system followed up with the Medical Devices Safety Unit of the Egyptian Pharmacovigilance Center, and must report any recall, FSN or FSCA taking place globally or any incident monitored in Egypt. A safety file is required for Class IIb/III and for Class I/IIa with regulatory actions; Class I/IIa (IVD A/B) devices without recalls in the previous three years submit Declaration 1 instead.

Incident reports go to the Medical Devices Safety Unit (MDSU), part of EDA, via the MIR form downloaded from the EDA website and submitted by e mail (pv.md@edaegypt.gov.eg); the latest EU Commission MIR form is acceptable and IMDRF adverse event terminology should be used. Follow up responses to MDSU queries are due within 15 days; investigation final reports within 15 days (no testing), 30 days (testing in Egypt) or 90 days (testing outside Egypt).

Only serious incidents occurring in Egypt are reported to the MDSU, by Manufacturer Initial Report (Annex 7): serious public health threat immediately, not later than 2 calendar days after the manufacturer establishes the causal relationship; death or unanticipated serious deterioration not later than 10 calendar days; any other serious incident/near incident not later than 15 calendar days. Uncertain cases must still be reported within the timeframe.

Manufacturers of devices made available on the Union market, other than investigational devices, must report to the relevant competent authorities — for Estonia, Ravimiamet — every serious incident involving those devices (except expected side effects documented and quantified in the product information and subject to trend reporting) and every field safety corrective action, including a corrective action undertaken in a third country in relation to a device also legally made available on the Union market.

Ravimiamet registers the data of a serious incident reported to it and notifies the reporter of this within ten working days of submission of the data. A field safety notice concerning a device made available on the Estonian market must be drawn up in Estonian; the initial urgent notice may be in English.

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.

general serious incidents: Immediately after causality established or reasonably possible, not later than 15 days after awareness (Art. 82(3) IVDR) · serious public health threat: Immediately, not later than 2 days (Art. 82(4) IVDR) · death or unanticipated serious deterioration: Not later than 10 days (Art. 82(5) IVDR)

general serious incidents: Immediately after causal relationship established or reasonably possible, and not later than 15 days after awareness (Art. 87(3)) · serious public health threat: Immediately, not later than 2 days (Art. 87(4)) · death or unanticipated serious deterioration: Immediately upon established/suspected causality, not later than 10 days (Art. 87(5)) · reporting channel: Reports submitted through the electronic system referred to in Art. 92 (EUDAMED vigilance); expected side effects documented and quantified in product information are subject to trend reporting instead

Serious incidents under MDR Art. 87 are reported on the Commission's Manufacturer Incident Report (MIR) form; MIR form version 7.3.1 is mandatory as from 1 May 2026 and versions published prior to December 2025 can no longer be used.

Manufacturers must report via the electronic system any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or of expected undesirable side effects, which could have a significant impact on the benefit risk analysis and have led or may lead to unacceptable risks to health or safety (Art. 88(1) MDR).

For legacy directive devices (placed on the market under MDR Art. 120(3)/IVDR Art. 110(3)), manufacturers report to Fimea: a serious threat to public health within 2 days, death or unexpected serious deterioration of a person's state of health within 10 days, and other reportable cases within 30 days of the manufacturer becoming aware of the event.

Manufacturers report serious incidents, trend reports, periodic summary reports and field safety corrective actions to Fimea by email to laitevaarat@fimea.fi (also fax +358 29 522 3002 or post to Fimea, PL 55, 00034 Helsinki; urgent cases first by phone +358 29 522 3341 with a written report to follow immediately) using the Commission MIR/FSCA/FSN forms until reporting through EUDAMED becomes possible; MIR form version 7.3.1 must be used from May 2026.

Fimea maintains a national incident register (vaaratilannerekisteri) that stores incident reports made by manufacturers and professional users; reports from professional maintainers and installers, other users and patients may also be stored; only the reporter's and contacts' names and contact details are stored as personal data.

Professional users (ammattimainen käyttäjä) must report to Fimea and to the manufacturer, authorised representative, importer or distributor dangerous situations that have led or could have led to endangering the health of a patient, user or other person and that arise from the device's characteristics, unintended side effects, performance deviation or failure, inadequate marking, inadequate or erroneous instructions for use, or another use related cause.

Any manufacturer placing devices on the French market, or its authorised representative (mandataire), must designate a materiovigilance correspondent established in France or, failing that, in another EU Member State, and communicate that person's identity without delay to the ANSM Director General (declared using the ANSM form sent to communications.dm@ansm.sante.fr).

Service providers (prestataires de services) and distributors of equipment mentioned in Art. L5232 3 CSP must also designate a materiovigilance correspondent and notify it to ANSM an extension of the correspondent duty beyond manufacturers and health facilities introduced by the 2026 recast.

Local materiovigilance correspondants must transmit to the ANSM Director General, without delay, every serious incident report received (plus incidents involving drug delivery or blood collection devices), and, on a quarterly cycle, every other incident report received.

For any incident occurring in France, manufacturers submit their reports (initial, combined, follow up or final MIR) to ANSM in PDF and XML versions by email at materiovigilance@ansm.sante.fr; Annex XVI products without medical purpose are subject to the same requirements; reports can be tracked in the Vigimater application.

Health professionals and professional users must report serious incidents (as defined in Article 2(65) MDR) without delay to the local materiovigilance correspondent when they work in a facility, or to the ANSM Director General when independent; they may report all other incidents; patients, approved patient associations and non professional users may also report incidents and serious incidents to the ANSM DG.

The holder of a medical device clinical investigation registration certificate must submit to the Agency information on suspected unexpected serious adverse reactions (SUSARs) arising in the agreed investigation that are known to the sponsor and require expedited reporting: within no more than 7 calendar days of the sponsor becoming aware for fatal or life threatening reactions, and within no more than 15 calendar days for all other SUSARs. For a multi year clinical investigation a summary safety report is submitted periodically, once a year. The information is submitted to the Agency electronically, on CIOMS or MEDWATCH forms, in Georgian or English. The certificate holder must also file an Annual Progress Report once a year and a Clinical Study Report within 12 months of the end of the investigation (6 months for paediatric investigations).

Anyone who professionally or commercially operates or uses medical devices must report suspected serious incidents (mutmaßliche schwerwiegende Vorkommnisse) that occur in that context immediately (unverzüglich) to the competent federal higher authority; the same applies to physicians and dentists who become aware of such incidents in the exercise of their profession.

The local representative for a regulated product shall monitor the safety of the product granted marketing approval and shall report an adverse effect or event to the Authority during the period for which the product is registered; the Authority continually monitors safety by analysing adverse effect/event reports.

For uniform documentation, EOF requires manufacturers to complete the standardized Manufacturers Incident Report (MIR) form and Field Safety Corrective Action (FSCA) form in the ENGLISH language (forms from MEDDEV 2.12 1 rev.6, Annexes 10.3 and 10.4); the MIR form is used for initial, follow up and final reports (selecting 'Type of report').

Manufacturers must report to EOF all serious incidents occurring within Greek territory of which they become aware in any way; initial reports (Initial Report, MIR form in English per MEDDEV 2.12 1 rev.6 Annex 10.3) to the EOF Adverse Events Department (Τμήμα Ανεπιθύμητων Ενεργειών) without unjustified delay: within 2 days for serious incidents threatening public health, 10 days for death or unexpected serious deterioration of health, 30 days for others; follow up and final reports per MEDDEV; where an incident results from combined use of devices of different manufacturers, each manufacturer submits a separate report.

Health professional users (medical bodies/medical institutions) are obliged to notify EOF of all serious incidents that come to their attention from use of medical devices in Greece; patients/consumers are encouraged to report. Users and patients report by completing the White Card (Λευκή Κάρτα) in the Greek language and sending it to the manufacturer and to EOF (Τμήμα Ανεπιθύμητων Ενεργειών; by post or vigilancematerial@eof.gr); involved devices should be quarantined and sent for examination to the manufacturer/supplier, not to EOF, unless EOF specifically requests.

Adverse incidents involving medical devices must be notified to MSPAS under the procedure established by Acuerdo Ministerial 418 2014, which covers suspicion of quality non compliance, therapeutic failure, adverse reactions to medicines and adverse incidents in medical devices within the health services network. Notification is an obligation of all medical, paramedical and other health professionals.

Adverse events that have resulted in death or serious injury must be reported by the LRP as soon as possible, and not later than 10 elapsed calendar days after the LRP becomes aware of the incident.

All other reportable adverse events must be reported not later than 30 elapsed calendar days after the LRP becomes aware; the LRP must follow up with a final report within 30 elapsed calendar days of the initial report.

Adverse events that have posed or are likely to pose a public health risk must be reported by the LRP to MDD within 48 hours.

An adverse event is reportable to MDD when all three basic criteria are met: the LRP becomes aware of an event that occurred with its listed device(s); the device may be associated with the event; and the event led or could have led to death or serious injury (per GN 03 clause 4.1); use errors are also reportable.

Healthcare providers and health workers must report incidents electronically in the format published by NNGYK; patients may also submit reports; NNGYK informs the manufacturer or authorised representative of the report, at the latest within 8 days of the report.

Until the EUDAMED vigilance modules become functional, incidents and accidents (including those arising in clinical investigations) are reported to the NNGYK mailbox amd.vig@nngyk.gov.hu stating the case number (iktatószám) and CIV ID; NNGYK publishes separate reporting forms for manufacturer, distributor and healthcare provider reporters.

Where a manufacturer learns that a device of its manufacture may have caused, or has caused, an incident, it must determine the severity and send an initial report to Lyfjastofnun within the following time limits: serious public health threat — without delay, or within 2 days where special reasons apply; death or serious deterioration in health — without delay, or within 10 days where special reasons apply; otherwise — without delay, or within 15 days where special reasons apply. The manufacturer must be able to justify any delay in reporting.

Under Icelandic law anyone who produces, sells, owns or uses medical devices and knows of a deviation, defect or malfunction that might cause or has caused harm to health must report it to Lyfjastofnun without delay. Where an operator has reason to believe that a device in its possession, intended for placing on the market or already on the market, is not safe or is otherwise not in conformity with the Regulations or the Act, it must immediately take the necessary corrective action to bring the device into conformity and withdraw or recall it as appropriate, and must inform the competent authorities.

Where a manufacturer of a device other than a custom made device foresees an interruption or discontinuation of supply, and it is realistically foreseeable that the interruption or discontinuation could lead to serious harm or the risk of serious harm to patients or public health in one or more EEA States, the manufacturer must inform Lyfjastofnun as well as the operators, health institutions and health professionals to which it directly supplies the device. The information must be provided at least six months before the foreseeable interruption or discontinuation, except in exceptional circumstances, and must state the reasons.

Import licence holders must inform the CLA forthwith, and in all circumstances within fifteen days, of any administrative action abroad taken on account of an adverse reaction market withdrawal, regulatory restrictions, cancellation of authorisation or declaration as not of standard quality in the country of origin or any market where the device is sold; the authorised agent must then immediately stop despatch and marketing of the device.

The Materiovigilance Programme of India (MvPI), approved by the Ministry of Health and Family Welfare on 6 July 2015, collects device adverse events: the Indian Pharmacopoeia Commission is the National Coordination Centre since 2018, SCTIMST Thiruvananthapuram is the National Collaboration Centre, and CDSCO is the national regulator; IPC publishes the adverse event reporting forms (licence holders/healthcare professionals, consumers, IVD) and a Field Safety Corrective Action form.

Manufacturing licence holders must inform the State or Central Licensing Authority of any suspected unexpected serious adverse event and action taken, including any recall, within fifteen days of the event coming to notice; Form MD 27 permission holders must report such events to the CLA within fifteen days of awareness (rule 65(d)).

The izin edar holder must operate device vigilance ('vigilans': detection, assessment, understanding, communication, control and prevention of adverse effects or other problems related to device use) and report it to the Minister, through the health information system integrated with the national health information system, within deadlines set by the Minister. Health professionals and health facilities may report device adverse events (kejadian tidak diinginkan/KTD) to the Minister; the national reporting channel is the e Watch Alat Kesehatan system, which also covers field safety corrective actions (FSCA).

The directorate operates the MDR quality problem reporting channel ('گزارش مشکلات کیفی MDR') on imed.ir, with a dedicated user guide ('راهنمای مشکلات کیفی MDR'), alongside safety notices and alerts sections; complaint handling runs under the defined process 'فرآیند رسیدگی به شکایات تجهیزات پزشکی'.

Manufacturers and authorised representatives submit vigilance reports to HPRA by email at devicesafety@hpra.ie (national channel alongside EUDAMED); the vigilance requirements are those of MDR/IVDR Chapter VII Section 2 and the reporting forms are the EU Commission (MDCG) forms.

An importer or distributor in Ireland that suspects a device presents a serious risk, or is a falsified device, must inform HPRA at once by email at devicesafety@hpra.ie.

The registration holder must perform monitoring and audit actions to evaluate registered devices and improve their safety and quality, report their performance to AMAR, and report every special event connected to the use of a registered device that comes to their knowledge, in three categories: (1) a severe malfunction of the device that occurred in Israel or another country and could endanger a patient's health; (2) use of the device that caused, or is suspected of having caused, harm to a patient's physical or mental health that is not expected in the normal course of the disease or treatment, or use that caused significant harm or a patient's death in Israel or another country; (3) an action taken by a health authority worldwide or a notice published by a manufacturer, registration holder or health authority regarding the device, its marketing and use, or new information published in the main scientific literature regarding the device's safety.

Reports of monitoring actions and special events are submitted to the Medical Device Division (AMAR) of the Ministry of Health by email to amar.pms@moh.health.gov.il; a dedicated malfunction report form for accessories and medical instrumentation exists for local manufacturers and importers.

Public or private health operators, directly or via the health structure involved, must report complaints (reclami, Art. 2(2)(a)) to the manufacturer — also via the relevant economic operators — and must concurrently inform the Ministry of Health for vigilance and complaint data management under MDR Art. 93(1); once they receive complaints and reports, mandatario, distributor and importer must inform the manufacturer per MDR Arts. 11(3)(g), 13(8), 14(5).

Public or private health operators who, in their activity, detect a serious incident as defined by MDR Art. 2(1)(65) — even if only suspected — involving a medical device must report it to the Ministry of Health, with terms and modalities set by one or more Ministerial decrees; the report is also sent to the manufacturer or its authorised representative, possibly via the distributor (Art. 10(5)). Lay users and patients may report incidents of any severity (Art. 10(3)).

Manufacturers of devices made available in Italy (other than those under investigation) report to the Ministry of Health serious incidents, including unexpected adverse side effects, and corrective safety actions, with timing and modalities per MDR Art. 87; they also report any statistically significant increase in frequency or severity of non serious incidents per MDR Art. 88 (trend reporting).

Unless the fact constitutes a crime, a manufacturer omitting the reports under MDR Arts. 87 and 88, failing to promptly conduct the necessary investigations, implement resulting actions and make the required communications per MDR Art. 89, is subject to an administrative pecuniary sanction of EUR 24,200 to 145,000; sanctions are reduced by one third for micro enterprises (Art. 27(48)).

Device MAHs and foreign special approval holders report to MHLW: within 15 days — malfunction suspected deaths, serious cases unpredictable from precautions (incl. foreign identical device malfunctions), infections, and foreign recall/suspension measures; within 30 days — other serious cases/malfunctions and trend changes; periodically — within 2 months after each 1 year period from approval (malfunctions with foreseeable death/serious risk and other specified trends).

The ADR/safety information reporting duty lies on the MAH and on foreign special approval holders (外国特例承認取得者); healthcare professionals have a separate reporting duty (Art. 68 10(2)).

JFDA operates a service for reporting adverse effects and complaints arising from use of devices, medical supplies and cosmetics: channels are the JFDA website, e mail (info@jfda.jo; jpc@jfda.jo), telephone (+962 6 5632000) and the main building; the service is free of charge, has a 4 day completion time, and issues an inspection report on the investigation results.

Initial incident reports by the manufacturer/authorized representative: serious public health threat — immediately, no later than 2 calendar days after awareness; death or unforeseen serious deterioration of health — immediately after the link is established; other cases — immediately, no later than 30 calendar days after awareness.

Information on adverse events (incidents) is submitted to the state expert organization as a notification (извещение) form, transmitted online via the expert organization's portal, fax, e mail, or on paper; the definition of adverse event covers malfunction or deterioration of the device or inadequate/incorrect accompanying information.

The manufacturer must investigate serious events and submit investigation reports to the Board as soon as possible but not later than 15 days; all other reportable events must be reported as soon as possible but not later than 30 elapsed calendar days following the date of awareness.

Adverse events that result in unanticipated death, unanticipated serious injury, or represent a serious public health threat must be reported to the Board immediately and not later than 2 calendar days after awareness by the manufacturer.

The manufacturer, directly or through its authorized representative, must report to the Board adverse events associated with medical devices that occurred in Kenya when: (a) an event has occurred (malfunction or deterioration in performance; incorrect or out of specification test result; design flaw discovered during design review; inaccuracy in labelling, IFU or promotional materials; serious public health threat; use error); (b) the manufacturer's device is associated with the event; and (c) the event led to death, serious injury, or a near incident. Incidents occurring outside Kenya that do not lead to an FSCA relevant to Kenya need not be reported.

All serious and non serious incidents/events that occurred in Kenya are reported to the Board using the medical devices incident reporting form (Annex 4) at pv.pharmacyboardkenya.org; PPB's general instruction is to report all suspected adverse events through the online reporting tool PvERS as soon as possible. PPB also maintains a Medical Devices Diagnostics Incident Form (Green) among its manual reporting forms, and manufacturers have primary responsibility (directly or through the authorized representative) for notifying users of device problems.

statement: The representative of a healthcare institution must send the State Agency of Medicines a medical device user incident report (signal report) within three days of a serious incident or a potential serious incident with a medical device, using the form in Annex 3 to the regulation or the electronic reporting form on the agency's website, and must inform the manufacturer, authorised representative or distributor of any deterioration of device parameters or malfunction and of any inaccuracies on labels or in instructions for use that could cause or have caused death or serious harm to a patient, user or third person. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: postmarket surveillance · localApplicationRequired: Yes · targetDecisionRetained: No

statement: Manufacturers of devices made available on the Union market must report any serious incident to the relevant competent authorities not later than 15 days after becoming aware of the incident. For a serious public health threat the report must be provided immediately and not later than 2 days after the manufacturer becomes aware of the threat. In the event of death or an unanticipated serious deterioration in a person's state of health, the report must be provided immediately after the manufacturer establishes or suspects a causal relationship, and not later than 10 days after becoming aware of the incident. Field safety corrective actions must be reported in advance of being undertaken, except in urgent cases. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: postmarket surveillance · localApplicationRequired: No · targetDecisionRetained: No

The MOPH must warn patients, users or any other concerned party when it becomes aware of an alert relating to a medical device that puts public health or patient safety at risk. The information may be manufacturer notifications or alerts coming from the competent authorities in GHTF member countries — a post market information reliance channel running in parallel to the premarket reliance routes.

The manufacturer, or its commercial representative, must report any adverse event to the Ministry of Public Health for every product it intends to place on the Lebanese market.

For products placed on the market under customs treaty law, Swissmedic is competent for vigilance reports (serious incidents occurring in Switzerland or Liechtenstein, field safety corrective actions there, periodic summary reports and trends); the Amt für Gesundheit is competent for vigilance reports in the EEA. Hospital vigilance contact persons report to Swissmedic for the customs channel.

Professionals who identify a serious incident (MDR Art. 2(65); for IVDs IVDR Art. 2(68)) during application of products within the scope of MDR Art. 1(4) / IVDR Art. 1(2) must report it to the supplier and to the Amt für Gesundheit; reporting may be done through a professional society; deadlines follow MDR Art. 87 / IVDR Art. 82.

Sponsors responsible for organising and implementing clinical investigations must report adverse events occurring during clinical investigations in the procedure established by Regulation (EU) 2017/745 or set by the Minister of Health or VASPVT; other persons appointed by the manufacturer must also report under this item.

Manufacturers (or authorised representatives, system/pack assemblers sterilisers) must report incidents in the procedure established by Regulation (EU) 2017/745 or the IVD regulation, or set by the Minister of Health or the institution empowered by him (VASPVT).

For any event related to a clinical investigation conducted in Luxembourg, the sponsor notifies without delay to meddevices.vigilance@ms.etat.lu using the form in MDCG 2020 10/2 Rev. 1: (1) any serious adverse event with an established or reasonably conceivable causal link to the device, comparator or investigation procedure — immediately, no later than 2 calendar days after the sponsor becomes aware; (2) any device deficiency that could have led to a serious adverse event, and any new finding on events already reported — no later than 7 calendar days. An initial incomplete report may be submitted to allow timely notification.

Notifications under MDR Art. 87 must be sent to meddevices.vigilance@ms.etat.lu using the most recent version of the MIR (Manufacturer Incident Report) form available on the European Commission website.

The EUDAMED Vigilance and Clinical Investigation modules are not yet operational; until their activation, national procedures continue to apply in Luxembourg. The CA page will be updated once the European Commission announces the entry into application of these modules.

Registration holders and filers who know or suspect a serious adverse device event must report it to ISAF within 24 hours; a detailed report must be submitted on ISAF demand. Serious adverse event means an event leading or possibly leading to serious harm to bodily integrity or death.

Establishments must report to the Authority incidents occurring in or outside Malaysia: within 30 days of awareness for device failure, deterioration in effectiveness, or labelling/IFU inadequacy; within 10 days where the incident led to (or could lead to) death or serious deterioration of health; within 48 hours for serious public health threats. Contravention: fine up to RM200,000 and/or 2 years imprisonment. If reportability is uncertain the report must still be submitted within the timeframe, and incomplete information must not delay reporting.

After completing the investigation of a reported incident, the establishment must submit the investigation report and form to the Authority within 30 days after submission of the Mandatory Problem Report; extensions of 90, 120 or 150 days after MPR submission may be granted on request.

Any economic operator that receives complaints or reports from healthcare professionals, patients or users about incidents related to a medical device it has made available on the local market must immediately forward that information to the competent authority — the Medicines Authority. Every economic operator must also keep a register of complaints, of non conforming devices and of recalls and withdrawals, and keep the Authority informed of that monitoring. The Authority may request any further information it deems necessary. The national vigilance channel is mdvigilance.medicinesauthority@gov.mt, and the Authority publishes device incident report forms for healthcare professionals and for the general public.

Manufacturers of devices made available on the Union market must report to the relevant competent authorities any serious incident involving such a device, and any field safety corrective action in respect of such a device — including a corrective action undertaken in a third country where the reason is not limited to the device made available there. A serious incident must be reported immediately after the manufacturer establishes that a causal relationship with its device is established or reasonably possible, and no later than 15 days after it becomes aware of the incident. In the event of a serious public health threat the report must be provided immediately and no later than 2 days after the manufacturer becomes aware of that threat. Reports are submitted through the electronic system under MDR Art. 92.

Adverse reactions of medicines or other insumos (including devices) arising during commercialization or use, notified by health professionals, published in scientific literature, or reported by international health bodies must be brought to the IMMEDIATE knowledge of the Secretaría by the registration holder, distributors or commercializers.

Adverse incident notifications are submitted through the Sistema de Notificación en Línea de Incidentes Adversos de Dispositivos Médicos to the Dirección Ejecutiva de Farmacopea y Farmacovigilancia (DEFFV), with separate online portals for registration holders (NotificacionTitular), health professionals (NotificacionProfesional) and users/patients (NotificacionPaciente) at tramiteselectronicos03.cofepris.gob.mx/TecnoVigilancia; official notification formats are published by COFEPRIS.

Manufacturers, authorised representatives, health professionals, patients and users may report incidents and any medical device vigilance event electronically to vigilance@amdm.gov.md. AMDM states that all incidents that have occurred, including minor ones, should be reported as soon as possible; that any defective functioning or deterioration of a device's characteristics and performance, and any inadequate labelling or instructions for use that may lead or may have led to death or serious deterioration of a patient's or user's state of health, should be reported; and that any technical or medical cause relating to a device's characteristics or performance that leads the manufacturer to systematically withdraw devices of the same type from the market should be reported. An incident is defined as a defect that causes or could cause death, injury or serious deterioration of the health of a patient, user or third party, or that affects environmental quality, as well as defects that, by repetition, cause disruption of medical activity or material, time or other losses.

The statutory vigilance system for medical devices is approved by a departmental normative act; AMDM publishes Ordinul MS nr. 211 din 21.03.2018 "Cu privire la sistemul de vigilență a dispozitivelor medicale" in that role, together with a guide on medical device vigilance and an information sheet for manufacturers. The agency publishes the same order as the applicable instrument on its incident reporting page, alongside the electronic reporting address.

Health organisations and supply organisations must keep a continuous record of information on adverse effects and safety issues connected with the use of medical equipment and medical consumables, and of non conformities of laboratory diagnostic devices, and must notify the state administrative body responsible for medicines and medical devices of each of them (тухай бүр). On receiving that information the Agency reviews it, rapidly informs the relevant organisations of the adverse effect, safety issue or non conformity, and implements risk prevention measures.

The head of the Medicines and Medical Devices Control and Regulatory Agency approved, by Order No. A/130 of 6 June 2025, the 'Procedure on reporting, recalling, rapidly alerting on and destroying quality and safety problems of medicines, medical devices and health supplementary products' as Annex 1 to that order, and made the heads of health and supply organisations and the heads of representative offices responsible for implementing it, with implementation assigned to the Pharmacovigilance and Research Division and supervision to the Administration and Management Division. The same order repealed the predecessor Order No. A/237 of 15 December 2022.

statement: The manufacturer, or the authorised representative, must notify the Institute without delay of an initiated safety corrective measure and must give a safety notice to all the entities listed in the incident reporting article. The manufacturer or authorised representative must also give the notified or designated body that carried out the conformity assessment information on all changes arising from the vigilance system where those changes affect the conformity of the device. · reportTiming: without delay (bez odlaganja)

statement: Healthcare institutions or vigilance coordinators, healthcare professionals, the manufacturer or its authorised representative, wholesalers, persons involved in the delivery or putting into service of a medical device, and persons responsible for calibration and maintenance of a device must inform the Institute without delay of a medical device incident: (1) any malfunction or alteration of the characteristics or performance of a device, and any irregularity in the labelling or instructions for use, which have led or may lead to the death of a patient or user or to a serious deterioration in their state of health; and (2) any technical or medical cause related to the device's performance that is the reason for the manufacturer or its authorised representative to withdraw from the market a device of the same type. Those entities must also inform the manufacturer or the authorised representative. The Institute notifies the health inspection and proposes appropriate measures. · reportToAuthority: Institut za ljekove i medicinska sredstva Crne Gore (CInMED) · reportTiming: without delay (bez odlaganja)

Materiovigilance covers the surveillance of incidents or risks of incidents arising from the use of medical devices after they are placed on the market, through a national materiovigilance system whose organisation and operation are fixed by regulation. The persons responsible for manufacturing, importing, exporting and distributing establishments, and health professionals who use medical devices, must report to the administration within forty eight hours any incident or risk of incident arising from the use of a device, and any failure or deterioration in the quality of those products of which they become aware.

DFDA publishes a Mandatory Problem Reporting Form (ADR report format PDF) on its official website for download and use in medical device problem/adverse event reporting.

Until EUDAMED vigilance reporting becomes mandatory, manufacturers and authorised representatives report serious incidents to the IGJ using the MIR form (Manufacturer Incident Report), sent by email to meldpunt@igj.nl with the completed form attached as PDF; once EUDAMED is fully functional it becomes the central reporting point.

For events involving death or serious deterioration in health, sponsors should submit an initial report as soon as possible and within 10 calendar days, and a final report within 120 calendar days; minor injury and product quality events require a final report within 120 calendar days (initial reports of minor injury events are no longer required).

Anyone can report an issue associated with a medical device to Medsafe at devices@health.govt.nz; patients, caregivers, healthcare professionals and suppliers are encouraged to report under the voluntary scheme. Non reportable events include: deficiencies found before use, patient condition root causes, service/shelf life issues, correct fail safe (malfunction protection) operation, events already described in a recall/alert, improper use or maintenance, and expected foreseeable events fully described in the IFU.

Dealers (distributors/suppliers/agents) of medical devices must follow up an initial reportable adverse event with a final report within 30 days of the initial report; if more than one dealer of a brand is involved, each must submit their own report.

Manufacturers must report device adverse events to NAFDAC: Death 48 hours of becoming aware; Serious Injury within Nigeria 48 hours; Serious Injury outside Nigeria 15 calendar days; Public Health Concern 10 calendar days; possible death or serious injury if the event recurs 30 calendar days; Non Serious Injury within Nigeria 90 calendar days; non serious injury outside Nigeria contained in the PSUR. Non serious injuries are also reportable.

Adverse event reports must be submitted using the Medical Device Adverse Event Reporting Form for Manufacturers (Appendix 1) or for End Users (Appendix 2) through pharmacovigilance@nafdac.gov.ng or at the nearest NAFDAC office; email size under 2MB.

Manufacturers must train distributors, suppliers and agents on NAFDAC device reporting requirements (keeping training plans and records as evidence), and distributors/suppliers collect and collate adverse event reports on the manufacturer's behalf under a signed vigilance agreement.

Device user facilities report adverse events using the end user form: Death 48 hours; Serious Injury 48 hours; Public Health Concern 10 calendar days; possible death or serious injury if recurrence 30 calendar days; Non Serious 90 calendar days. Reports to manufacturers must also be notified to NAFDAC with documentary evidence.

For a medical device under clinical investigation, a serious unexpected adverse reaction that causes death or is life threatening must be reported within 24 hours as an initial report, with the full report filed within seven days; a serious non fatal reaction is reported within 15 days.

The materiovigilance rulebook provides for the exchange of materiovigilance information with the competent authorities of other countries, which is how MALMED receives and forwards incident information about devices on its market.

The Law provides that the pharmacovigilance provisions of Articles 87 to 89 apply correspondingly to medical devices as materiovigilance. By that cross reference the reporting deadlines for device incidents are 30 days for a non serious adverse reaction, 15 days for a serious adverse reaction, and 24 hours where the serious adverse reaction has a fatal outcome.

seriousPublicHealthThreat: 2 days · death: 10 days · unexpectedSeriousDeterioration: 10 days · otherSeriousIncidents: 15 days · clock: From the date the manufacturer became aware of the incident until the report is sent to the authorities

Healthcare facilities in Norway have a national obligation to report serious incidents that have or may have a connection with the use of a medical device; they report via the national reporting portal melde.no.

Serious incidents occurring in Norway are reported to the Norwegian Medical Products Agency using the common European Manufacturer Incident Report (MIR, version 7.3.1), sent by email with both PDF and XML versions attached; NoMA responds with a case number to be quoted in subsequent correspondence.

Transitional national duty: anyone producing devices in their business must without undue delay report to Direktoratet for medisinske produkter any malfunction, performance deterioration or label/IFU deficiency that led or could have led to death or serious worsening of health, and any technical or medical reason prompting systematic withdrawal or device modification.

Investigation must be concluded and the final report submitted to the Medical Device Vigilance Section within 15 days (no testing/technical evaluation needed), 30 days (device tested inside Oman), or 90 days (device tested outside Oman) from occurrence or awareness.

Initial adverse event/complaint reports to the Medical Device Vigilance Section: within 2 working days for events posing a serious threat to public health; within 10 working days for unexpected death or serious unexpected injury; within 30 working days for all other events.

Under Decision 113/2020 Article 90, users of medical devices must inform the Drug Safety Center about any adverse events/complaints related to the use of medical devices within a period from their occurrence according to severity level; reports are received by the Medical Device Vigilance Section.

Under rule 19(10), where a device is approved for free sale by a related company in USA, EU countries, Canada, Japan or Australia and is withdrawn, banned or restricted for safety reasons in any of those countries, the manufacturer or importer must inform the MDB within thirty days of the information coming to his knowledge and take appropriate action within the shortest possible time. Under rule 19(12), any adverse reaction not included in the enlistment or registration application that is reported in any rule 67 country must be reported to the MDB within thirty days by the manufacturer or importer.

Under rule 19(9)(b), for new medical devices the registration holder must supply the MDB, as soon as possible and in any event within fourteen days, with reports in duplicate of all records respecting failure of distributed batches to meet required specifications, unexpected side effects, injury, toxicity or sensitivity reactions, and unusual failure to demonstrate expected performance (rule 19(8) clauses (f), (g) and (h)).

The investigation process is determined by the risk level of the event, adverse incident or failure, and the investigation period may not exceed ninety working days after complete documentation is received.

Holders of sanitary registrations must notify DINAVISA within 72 hours of learning of the generation of an international alert reported by the parent company or by a health agency worldwide that involves the medical devices they commercialise.

A serious adverse event or incident occurring in Paraguay must be reported immediately and within 24 hours of becoming aware of it. Non serious adverse events or incidents occurring in Paraguay must be reported within 30 calendar days of becoming aware of them. Reporting runs to DINAVISA under the National Tecnovigilancia System.

Manufacturers, importers and registration holders must report to the ANM suspicions of adverse reactions and events for the products they manufacture or market; health professionals and establishments must likewise notify. Holders are integrants of the Sistema Peruano de Farmacovigilancia (D.S. 013 2014 SA Art. 1), whose activities are regulated by RM level technical standards.

Suspicions of mild and moderate adverse reactions or incidents must be submitted within no more than 20 calendar days of becoming aware, in ANM approved formats.

Registration and certificate holders must report suspicions of serious adverse reactions and incidents within 24 hours of becoming aware, using ANM approved formats and available communication means, and must additionally submit the investigation report of the serious case within 10 calendar days of receiving the notification. Public health risk lots must also be communicated within 24 hours (numeral 6.7 m). DIGEMID's NotiMED platform is used for serious reports.

Incidents that caused or contributed to death, serious illness or serious injury of a consumer, patient or any person must be reported to the FDA through the Center for Device Regulation, Radiation Health and Research; the qualified person of the establishment is responsible for ensuring adverse events are handled, documented and reported.

Professional users, healthcare providers, diagnostic laboratories, importers, distributors and repair/service/maintenance/calibration entities that establish a serious incident in the course of their activity must report it immediately to the manufacturer or authorised representative and send a copy to the President of URPL; anyone may report a serious incident directly to URPL; the duty lapses if the incident has already been reported; if the manufacturer's or AR's address cannot be established, the report goes to the Polish supplier with a copy to URPL.

Manufacturers' serious incident reports and explanatory statements (MDR Art. 87 88, IVDR Art. 82 83) are directed to the President of URPL as the competent authority for incidents occurring in Poland; reports are made in Polish or English via incydenty@urpl.gov.pl, e Doręczenia AE:PL 26545 10069 UIJGF 16, post or in person; safety correspondence may be conducted in English without translation and without a qualified electronic signature.

A field safety corrective action notice (notatka bezpieczeństwa) addressed to recipients in Poland must be drawn up in Polish; URPL publishes it in its BIP where public health protection so requires.

Serious incident reports to URPL use the official report form template (formularz ZIM) laid down by the Minister of Health regulation of 12 December 2022 (Dz.U. 2022 poz. 2682); URPL publishes the current bilingual Polish English form on its service page and accepts it by e mail, e Doręczenia, post or in person.

Until the EUDAMED vigilance module is implemented, serious incidents and FSCA are reported to INFARMED using the EU harmonized forms published by the European Commission; all communication is by e mail to dvps@infarmed.pt.

Health professionals (in or outside the SNS), other professional users and other interested parties must equally notify INFARMED of serious incidents they become aware of as soon as possible, without prejudice to also informing manufacturers, mandatários, importers and distributors.

The persons referred to in MDR Art. 22 must additionally communicate to INFARMED all information on suspicions of serious incidents occurring in Portugal after devices are placed on the market, including incidents involving or related to reprocessed single use devices.

The manufacturer must declare that the IMD proposed for registration is not facing legal proceedings, bans or suspended use in any country, and undertake that, if any such proceedings arise against a registered IMD, the manufacturer will inform the IMD Committee within 2 weeks.

For medical devices, within maximum 10 days of receiving the rationale under MDR art. 87(11) third paragraph, ANMDMR informs the manufacturer if it disagrees with the conclusion and may require a report under art. 87(1) (5) and that appropriate actions be taken; equivalent 10 day rule for IVDs under IVDR art. 82(11).

The field safety notice under MDR art. 89(8) must be drafted in both English and Romanian and made available without delay to users of the device; for devices used exclusively by healthcare professionals, at their request it may be provided in English only.

Healthcare professionals, patients and users must report to ANMDMR any suspected serious incident with devices or IVDs they handle, within maximum 15 days from the date the incident occurred, depending on its consequences, using the national form; reports go to mdevice@anm.ro or by post.

Public and private health institutions in Romania must report to ANMDMR serious incidents involving use of devices manufactured in house for their own use, and the corrective measures taken.

ANMDMR centrally registers at national level every report by IVD manufacturers (other than performance study devices) of serious incidents and field safety corrective actions; manufacturers report serious incidents respecting the IVDR art. 82 deadlines, using the Commission provided forms.

ANMDMR centrally registers at national level every report by manufacturers (other than investigational devices) of serious incidents and field safety corrective actions; manufacturers report serious incidents to ANMDMR respecting the MDR art. 87 deadlines, using the forms made available by the European Commission (MIR).

Reports are submitted electronically through the Automated System 'Monitoring of Safety of Medical Devices' (Автоматизированная система «Мониторинг безопасности медицинских изделий»); published e forms include 'Submit adverse event message' and 'Submit post registration clinical monitoring report', plus a notification card (Карта извещение) template for adverse events/incidents related to device use.

Where a threat to life and health is confirmed, the manufacturer of the device (or its authorized representative) must provide Roszdravnadzor with an adverse event report, a corrective actions report, and a safety notice within the time limits set by the requirements.

All subjects of circulation of medical devices must report to Roszdravnadzor every case of identified side effects not indicated in the instructions for use or operating manual of the device.

The current procedure for subjects of circulation to report all cases of identified side effects not indicated in the IFU/operating manual is Minzdrav Order No. 1113н of 19.10.2020.

Minzdrav Order No. 541н of 26.05.2026 approves a new Procedure for reporting all cases of identified adverse events at all stages of circulation of the relevant medical device in Russia and the territories of other states; the order was published by Roszdravnadzor on 09.06.2026.

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.

Investigation procedures must be concluded and the final report submitted to NCMDR within: 15 days for events not requiring testing or technical evaluation; 30 days where testing inside KSA is required; 60 days where testing outside KSA is required. NCMDR follow up inquiries must be answered within 5 days.

Adverse events or complaints must be reported to NCMDR: within 2 days from occurrence or awareness if they represent a serious public health threat; within 10 days if they may cause or contribute to death or serious injury; within 30 days for any effect other than the above.

Adverse event/complaint information and documents are submitted through: the National Center for Medical Device Reporting (NCMDR), the Saudi Vigilance system, or the SFDA Call Center (19999); FSCA related correspondence also goes to NCMDR email ncmdr.md@sfda.gov.sa.

Matériovigilance is defined in the device decree as the surveillance of incidents linked to the use of medical devices, and the device post market surveillance system comprises import/export control, quality control, after sales service, control of promotion and advertising, the fight against substandard and falsified devices and illicit sale, inspection of the actors in the supply chain, and matériovigilance. The national vigilance system is instituted by a separate decree: the pharmaceutical regulation structure ensures the prevention and management of risks linked to the use of medicines and other health products, and relies on two vigilance organs created within it — the Comité technique des experts de vigilances and the Commission nationale de Vigilances — and hosts the Centre national de Vigilances, working with regional vigilance coordinators in each regional health directorate.

ALIMS records and evaluates incidents defined as: (1) any malfunction or alteration of device characteristics or performance, and irregularities in marking or instructions for use, which led or could have led to death or serious deterioration of health of the patient or user; (2) any technical or medical reason related to performance causing the manufacturer/AR to withdraw devices of the same type from the market. Health institutions, private practice, healthcare workers, manufacturers, ARs, wholesalers, persons in distribution/delivery/putting into service, and persons responsible for calibration and maintenance must notify ALIMS without delay of any incident; health institutions appoint a vigilance coordinator reported to ALIMS.

Manufacturer/AR report to ALIMS, without delay after establishing the device event link: a serious threat to public health at the latest within 2 calendar days of awareness; death or unexpected deterioration of health at the latest within 10 calendar days; other incidents at the latest within 30 calendar days. Where reporting obligation remains uncertain, the report is filed within the deadline for that incident type. Reporting is electronic via the Agency portal, with initial, follow up and final reports on the prescribed annexes.

The clock for reporting starts as soon as any personnel in the company, including sales representatives, are made aware of the adverse event.

Defects or adverse effects that have led to the death of a patient or user, or a serious deterioration in their state of health, must be reported within 10 days; HSA's page states 10 calendar days with a follow up final report within 30 days of the initial report.

Defects or adverse effects that might lead to death or serious deterioration if they recurred must be reported within 30 days (30 calendar days per HSA's adverse events page).

Defects or adverse effects that may seriously threaten public health must be reported to the Authority within 48 hours.

All companies dealing in medical devices importers, manufacturers, suppliers and registrants must report adverse events of their products, whether registered or unregistered; reports are made using the Mandatory Medical Device Adverse Event Reporting Form for Medical Device Dealers by email. Foreign adverse events do not require reporting unless registration/licence conditions or HSA notices require it.

ŠÚKL accepts reports of suspected serious incidents (závažné nehody) and adverse events involving devices from healthcare professionals and from patients in Slovakia, using form TL SZP 075 sent to vigilanciazp@sukl.sk; ŠÚKL processes and evaluates the report and informs the device's manufacturer. Manufacturer MIR reports are made on the European Commission/MDCG forms.

A health worker reports to JAZMP any suspected serious incident with a device (within the meaning of Art. 87(1)(a) MDR / Art. 82(1) IVDR) through the information system, as soon as possible and at the latest within 48 hours of establishing or becoming aware of the serious incident.

Until EUDAMED begins functioning, RS seated manufacturers and authorised representatives report serious incidents occurring in the EU to the member state where the incident occurred and to the notified body that issued the certificate; field safety corrective actions on EU market devices (and third country FSCA whose reason is not limited to that market) are reported to JAZMP, the member state authority and the notified body; final investigation reports go to the member state where the incident occurred; trend reports to the member states where incidents occurred.

JAZMP operates the national vigilance channel: vigilance system participants report serious incidents with devices occurring in Slovenia to JAZMP (online web form available for actual or suspected serious incidents); the manufacturer or authorised representative must notify field safety corrective actions to both JAZMP and the users of the devices.

All reportable adverse events (regulation 17 duties of the authorised representative and holder of a certificate of registration) must be submitted on the Medical Device Adverse Event Reporting Form (GLF MD 11A) to mdvigilance@sahpra.org.za; users may also report events to the licensee, manufacturer, authorised representative or the Council.

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Device handlers (의료기기취급자) who become aware of death or serious adverse effects occurring or likely to occur during device use must report immediately to the MFDS Commissioner and keep records.

Under Enforcement Rule Article 51: death or life threatening adverse effects must be reported within 7 days, with a detailed follow up report within 8 days of the first report; other serious outcomes (hospitalisation or extension, permanent disability/function loss, congenital anomaly, etc.) within 15 days.

Companies (manufacturers and other economic operators) notify incidents and field safety corrective actions to AEMPS using the notification forms of the Spanish device vigilance guidelines — the Manufacturer's Incident Report (MIR, v7.2) and the FSCA form — sent by email to psvigilancia@aemps.es or by fax to +34 918225289.

Healthcare professionals and authorities who become aware of a serious incident in the course of their activity must notify AEMPS through its electronic office (portal NotificaPS); the regions validate the notifications received through NotificaPS before remission to the AEMPS device vigilance area, and AEMPS forwards notifications to the manufacturer; patients and users may also notify serious incidents electronically. A serious incident is one that directly or indirectly led or could have led to death, serious temporary or permanent deterioration of health, or a serious public health threat.

Healthcare professionals (doctors, dentists, pharmacists, nurses) are encouraged to report suspected adverse events encountered in practice via the NMRA ADR Google form; a copy of the form is forwarded to the Adverse Drug Reaction Monitoring Unit, Department of Pharmacology, Faculty of Medicine, University of Colombo.

Reporting deadlines from manufacturer awareness: serious public health threat — immediately, at the latest 2 days; death or unexpected serious deterioration of a person's health — immediately, at the latest 10 days; other serious incidents — immediately once a causal link is established (or reasonably possible), at the latest 15 days from awareness. An incomplete initial report should be sent first and completed with a final report after the investigation.

Manufacturers report serious incidents, corrective safety actions (FSCA), trends and periodic safety updates (PSR) to Läkemedelsverket as the Swedish competent authority.

Manufacturers must follow up, investigate and report serious incidents that occurred in Sweden to Läkemedelsverket (incidents in other EU countries to the competent authority of that country). Importers/distributors who discover a serious risk or falsification must inform Läkemedelsverket and the manufacturer or its authorised representative, and pass on all suspected incidents to the manufacturer/AR. Until Eudamed is fully functional, manufacturer reporting goes through Läkemedelsverket's e service using the EU MIR form uploaded in PDF and XML. Scope: all CE marked devices and IVDs (incl. accessories, procedure packs), custom made devices and NMI.

The manufacturer of an IVD made available on the Swiss market must report to Swissmedic serious incidents in connection with the product occurring in Switzerland, as soon as they become aware, and field safety corrective actions taken in Switzerland; exceptions, modalities, periodic summary reporting, trend reporting and analysis follow Art. 24(5) and Arts. 82 84 EU IVDR. Where a CH REP is required under Art. 44 IvDO, the CH REP bears reporting responsibility and must submit trend reports and final reports ex officio.

The manufacturer of a product made available in Switzerland, or the person assembling systems or procedure packs and making them available in Switzerland, must report to Swissmedic: (a) serious incidents in connection with the product occurring in Switzerland, as soon as they become aware of them; and (b) field safety corrective actions taken in Switzerland. Exceptions, modalities, periodic summary reporting, trend reporting and analysis follow Art. 27(5) and Arts. 87 89 EU MDR. Where a CH REP is required, the CH REP bears reporting responsibility and must submit trend reports and final reports ex officio.

Reports to Swissmedic must be made electronically and in machine readable form (Art. 66(5) MedDO); Swissmedic designates the forms: serious incidents are reported with the MIR form (in English or a Swiss national language) by e mail as XML plus PDF to materiovigilance@swissmedic.ch; the scope covers serious incidents that occurred in Switzerland or Liechtenstein; where the manufacturer or SPPP is not established in Switzerland or Liechtenstein, the authorised representative assumes reporting responsibility.

The licence holder or filer must complete the report within 15 days of discovering the event, then proactively investigate and evaluate corrective and preventive measures (reporting records kept at least five years).

Medical care institutions report within 7 days of discovery for death or life threatening events and within 15 days for other serious events. Reporting is done via the central authority's designated online system (oral report with later completion where necessary; paper, fax, letter or email fallback where online reporting is impossible).

Device firms (licence holders/filers) and medical care institutions that discover a serious adverse event must report it to the central authority (or its commissioned body). A serious adverse event is any of the following caused (or potentially caused) by device use: death; life threatening harm; permanent disability; congenital malformation in fetuses/infants; necessity of hospitalisation or prolonged hospitalisation; or other complications that may cause permanent injury.

Submission of adverse effect reports associated with the use of the device is a standing condition for validity of registration.

The applicant and the Local Responsible Person must monitor the device on the market and inform TMDA immediately after detecting any problem relating to a registered device, such as serious manufacturing defects which may endanger public health.

Adverse events/incidents and medical device/diagnostic problems are reported to TMDA through the Safety and Quality Reporting Tool (SQRT) at https://sqrt.tmda.go.tz/; all reports submitted are kept confidential.

Events involving death or serious injury must be reported immediately, at the latest within 10 days of becoming aware.

Where scientific data or evidence indicate that recurrence could lead to death or serious injury, the initial report is due within 30 days of awareness; follow up reports are due within 30 days of submitting the initial report.

Events constituting a serious threat to public health must be reported immediately, at the latest within 48 hours of becoming aware.

Events occurring outside Thailand are reported twice a year: events in January June by August, and events in July December by February, plus any additional reports requested by the Thai FDA; devices produced and sold only in Thailand follow the domestic timelines.

Field safety corrective actions (domestic and foreign): initial report within 48 hours of becoming aware that an FSCA will be carried out; follow up or final report within 21 days of the previous report.

Registered establishments, licensees, detailed listing notifiers and notifiers must report device malfunctions (ผลการทำงานอันผิดปกติ) and adverse events (เหตุการณ์อันไม่พึงประสงค์) affecting consumers, wherever they occur (domestic or foreign), to the Thai FDA within prescribed periods.

A serious vigilance incident internationally is a bar to the light administrative AMC track: the product is returned to control by the ANMPS technical services at the next importation until a satisfactory evaluation report or a compliant analysis report is obtained. Tunisia's vigilance criterion is therefore expressly extraterritorial — it is not limited to incidents occurring on Tunisian territory. ANMPS holds the materiovigilance function for medical devices, listed as a distinct agency activity alongside pharmacovigilance and cosmétovigilance, with complaint management, and it also lists market surveillance, inspection including good manufacturing practice control, and quality control of medical devices among its activities.

Under the IVD Regulation, serious incidents are reported no later than 15 days after the manufacturer becomes aware, and immediately — not more than 2 days — for a serious public health threat; the report is submitted via the electronic system.

Serious incidents must be reported via the electronic system without undue delay and no later than: 15 days after awareness; 2 days for a serious public health threat; 10 days for death or unexpected serious deterioration of health. FSCAs and recalls are reported before implementation except in emergencies. These Article 85 deadlines apply only from 6 months after the EU OJ notice that the relevant EUDAMED electronic system is functional (Madde 111(1)(a)).

Under the operative 2010 Tebliğ, events in Turkey are reported to the Ministry electronically: immediately for a serious public health threat (2 days where force majeure exists); immediately for the other category; 10 days for death or unexpected serious deterioration; 30 days for other situations; based on Law No. 4703.

NDA's medical devices regulatory page requires every company dealing in medical devices — importers, manufacturers, suppliers and registrants — to report adverse events of their products. Reportable AEs follow a report if in doubt disposition and three criteria: an AE (or potential AE) occurred, the device is associated with it, and it results in a serious threat to public health, the death of a patient, user or other person, or a serious deterioration in health (including an initial non serious AE that could lead to death or serious injury on recurrence). Reporting channels: the WHO UMC primary reporting portal (https://primaryreporting.who umc.org/Reporting/Reporter?OrganizationID=UG), the NDA med safety mobile app on Google Play, or the toll free line 0800 101 999.

The manufacturer must immediately notify Держлікслужба of any malfunction or deterioration of characteristics and/or performance of a device, or inadequacy of the instructions, that could lead to the death of a consumer/user or a significant deterioration of their health, and of the reasons for systematic recall of devices of the same type.

EDE establishes and manages a national electronic system to receive and document adverse event and related reports from establishments, authorities, health professionals, patients and the public.

Non serious side effects, adverse events or adverse reactions must be reported to EDE within 90 days of receiving the related reports, in the form of complete reports.

The establishments, authorities and health professionals listed in Article 68(3) must inform EDE of medical product quality defects within 15 days of receiving the complete related reports.

Serious side effects, serious adverse events and serious adverse reactions (expected or unexpected) must be reported to EDE as soon as possible and no later than 5 days from knowledge, with follow up reports within a maximum of 15 days.

The establishments, authorities and health professionals listed in Article 68(3) must inform EDE immediately upon learning of suspected fraud or counterfeiting of a medical product or suspected illegal trade in medical products by third parties.

The manufacturer must report any serious incident involving its device to the Secretary of State: within 2 days where the incident involves a serious public health threat; within 10 days where there is a death or an unanticipated serious deterioration in a person's state of health; and within 15 days for any other serious incident in each case after becoming aware of the incident and establishing the causal (or reasonably possible causal) relationship. Where similar incidents recur and the cause is identified or a field safety corrective action taken, the manufacturer and the Secretary of State may agree periodic summary reports instead of individual reports.

Manufacturers must report to FDA no later than 30 calendar days after the day they receive or otherwise become aware of information, from any source, that reasonably suggests a device they market may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur (21 CFR 803.50).

Manufacturers must submit a five day report no later than 5 work days after the day they become aware that (a) an MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, or (b) FDA has made a written request for a report (21 CFR 803.53(a) (b)).

The MSP BPM portal offers separate online trámites 'Notificación de Eventos Adversos con Reactivos de Diagnóstico', 'Notificación de Eventos Adversos con Equipos Médicos' and 'Notificación de Eventos Adversos con Dispositivos Terapéuticos' (authentication required), plus a 'Registro de Comercialización de DEA/DESA por Empresas de Equipos Médicos'.

Companies commercialising the regulated products must notify the MSP and the users when they detect adverse effects or receive notifications from foreign regulators, manufacturers or national users about questioned products; the notification must include the name and registration number of the questioned products, the date of withdrawal of the product(s), units sold, buyers and other technovigilance relevant information. Omission of this obligation is deemed fraud.

The applicant must continually submit to the Centre information on adverse effects (ножўя таъсирлар) that become known during use of the device in medical practice, in the procedure established by the Ministry of Health, and must immediately inform the Centre if the device's registration certificate is suspended, cancelled or withdrawn in other states or a certificate application was refused there.

On a warning from a competent Vietnamese or international authority about a latent risk that seriously threatens public health or could cause death, the marketing number holder must inform the health facilities using the device and complete an investigation and determination of the risk within 30 days of receiving the warning, with a written report to MOH if more time is needed. Where an incident has already occurred that seriously threatens public health or causes death to users, the holder must publish a notice and notify the buyers, users and MOH, suspend circulation of the affected lot, investigate the cause, and report the investigation results to MOH.

statement: ZAMRA's Guideline on Recall of Medicines and Allied Substances (March 2023) defines 'allied substances' by reference to section 3 of the Act, which includes medical devices, and defines 'product' to include a medicine and an allied substance; 'recall' is a process for withdrawing or removing a medicine and/or allied substance from the market. The guideline is made under the Medicines and Allied Substances Act No. 3 of 2013, under which the Authority regulates and controls medicines and allied substances and establishes, maintains and enforces standards. For non IVD devices the marketing authorisation holder must operate a vigilance system and provide routine reports to the Authority (non IVD guideline s.1(p)).

statement: MCAZ's Strategic Plan 2026 2030 lists among the Pharmacovigilance and Clinical Trials Division's functions 'Pharmacovigilance (PV) (safety monitoring of medicines, vaccines & medical devices) including active PV programs & projects', 'Monitoring product defects & recalls', and 'Regulation of clinical trials of medicines, vaccines & medical devices, including Good Clinical Practice (GCP) inspections'. MCAZ's Reliance Policy similarly provides that in vigilance it 'considers vigilance related decisions, reports or information from other countries, regional or international bodies such as WHO in making decisions on the safety and effectiveness of medical products', from WHO global pharmacovigilance newsletters and databases, WHO listed countries, and any other countries or bodies with functional and reliable pharmacovigilance systems. Neither instrument creates a device specific adverse event reporting duty, timeframe or field safety notice procedure, and the device regulations themselves contain no vigilance clause.