Recall, FSCA & market surveillance by country

AKBPM, by order of the minister responsible for health, withdraws from the market or restricts the use of a device that may endanger the health or safety of patients, users or others (due to failure to meet essential requirements, incorrect application of standards, or deficiencies in the standards themselves); the competent authority must require the manufacturer or its representative to take all corrective actions to bring the device into compliance, to restrict its availability on the market, to retrieve or withdraw it within a defined reasonable period communicated to the manufacturer/representative; non compliance with such requirements is fined 1,000,000 lekë, and retail sale of unregistered devices 200,000 lekë.

When a homologation decision is withdrawn (temporarily or definitively), the holder and/or operator must take all useful measures to stop distribution of the device, must withdraw, destroy or re ship the marketed lot(s), and must comply with all measures taken by ANPP; withdrawal, destruction or re shipping of non conforming devices are at the holder's/operator's cost, with modalities set by ministerial arrêté.

For reasons of health security and/or quality, ANPP can pronounce temporary withdrawal of the homologation decision for a period not exceeding 12 months; the withdrawal becomes definitive at the end of that period if the holder has not lifted the reservations that motivated it; withdrawal requests can originate from the ministers, ANSS, national health institutions, national and international pharmaceutical regulation bodies, and materiovigilance establishments; withdrawal decisions must be motivated and may be publicised.

When illegitimate product is detected, ANMAT market control actions include a nationwide prohibition on use and commercialization of the involved manufacturing lot, together with traceability tracking of units and coordination with jurisdictions.

Disposición ANMAT 8194/2023 provides for the 'Nota de Seguridad en Campo' (field safety notice) as the communication instrument linked to field safety corrective actions.

Where a fact of circulation in Armenia of medical devices posing a danger to human life or health is detected, the authorised body (Ministry of Health), after confirming that fact, in accordance with the relevant international treaties, notifies and takes measures to prohibit the circulation of such medical devices in Armenia in the procedure established by legislation.

The importer cooperates with the authorised body, the manufacturer or the manufacturer's authorised representative in order to take all measures necessary to bring a device presenting a danger into conformity with the requirements established by legislation, to stop its circulation within the established time limits, or to withdraw it from circulation (recall). Where the importer receives a decision refusing import, it confirms receipt and within 90 days informs the authorised body in writing of the destruction or re export of the refused devices, attaching the documents evidencing the destruction or re export. Devices unsuitable for use, including devices whose expiry date has passed, are subject to re export or destruction in the procedure established by legislation.

The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) took effect on 5 March 2025 and replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG); recall notifications are lodged via TGA Business Services, TGA aims to agree notifications within 7 business days, and actions are classified Class I/II/III with wholesale, hospital, retail and consumer levels, published in the DRAC database.

A field safety corrective action in Austria is reported to BASG by email with the FSCA report form (.xml and .pdf files) together with the customer list, the field safety notification in German and a timetable.

Where state registration is suspended, the Ministry takes a decision on the recall of the medicinal products, medicinal substances and medical devices already in circulation in accordance with the 'Rules on the recall of medicinal products' approved by Cabinet of Ministers Resolution No. 460 of 27 November 2019. The Rules themselves set no separate device specific recall procedure.

When a field safety notice affects the Bahraini market, the authorized representative must provide a copy of the notice to NHRA within 2 working days for very high risk notices, 5 working days for high risk notices and 10 working days for moderate risk notices. The applicant then has one month from confirmation to supply the acknowledgment and evidence of action taken. Where the notice does not affect Bahrain, an official signed letter from the manufacturer confirming this must be provided.

If a harmful reaction appears in humans or animals from use of a registered drug (including devices), or a human or animal dies as part of such a reaction, the Licensing Authority may immediately order sale stopped and marketing suspended until further instructions.

Where a drug is substandard or its registration is cancelled or suspended, the Licensing Authority may order the product to be withdrawn from the market and destroyed; after confirmation of a harmful reaction, the establishment must destroy the product and inform the Licensing Authority.

RUP CEIZ maintains a database of substandard and falsified devices identified in Belarus and exchanges information on them with the competent authorities of EAEU member states and other states under international treaties and EAEU law.

Substandard, falsified and expired devices must be withdrawn from circulation, returned to the producer (or its authorized representative) or destroyed, by decision of their owner or of the Ministry of Health. The owner must withdraw them immediately and return them within 30 calendar days; the producer must accept them and perform corrective actions or destroy them within 30 calendar days. A Ministry withdrawal decision is issued by ministerial order within 15 working days of a written notification, published on the official sites within 3 working days.

Field safety notices must be drafted in the three national languages under Article 65 of the Law of 22 December 2020 on medical devices (Article 64 of the Law of 15 June 2022 for IVDs); where a device is for professional use only, the FSNs are only available in English. FAMHP publishes an Excel list of Belgium relevant FSNs updated weekly; anyone receiving an FSN not on the list should report it to vigilance.meddev@afmps.be.

The federal minister or their delegate may suspend the activities of an economic operator that does not comply with its obligations (including Article 31(5) of Regulation 2017/745) until the obligations are met; the King sets the procedure.

statement: A batch withdrawn from the market under Bolivia's National System for the Vigilance and Control of Medicines is classified by the seriousness of the defect, and the classification fixes the deadline by which the company must complete the withdrawal: Clase I (a reasonable probability that use of or exposure to the batch will cause serious adverse health consequences or death) — 72 hours; Clase II (use of or exposure to the batch may cause adverse health consequences that are temporary or medically reversible, or where the probability of serious adverse health consequences is remote) — one month; Clase III (use of or exposure to the batch does not appear to cause adverse health consequences) — three months. Where a Registro Sanitario or an active principle is cancelled, the market withdrawal is likewise graded by seriousness and must be completed by the company within 72 hours, three months or nine months, as the case may be. · article: Numerales 6.13.1 and 6.14

statement: The withdrawal of a batch from the Bolivian market is the voluntary, or authority ordered, procedure by which a manufacturing batch is taken off the market; it must be executed by the legal representative or manufacturer and must be carried out at the various levels of distribution according to the seriousness of the defect or problem with the product. Because withdrawal is the responsibility of the legal representative — whether an industrial pharmaceutical laboratory, an importer or a national distributor — every company must maintain written procedures setting out its product withdrawal policy and must make them known to the DINAMED authorities. The Dirección de Medicamentos y Tecnología en Salud must be informed of every withdrawal, and may call on authorised governmental or non governmental bodies to assist; inspectors may verify the withdrawal process at any time for faithful compliance, together with the report stating the batch number, the number of units making up the batch, the total units withdrawn, the cause that determined the withdrawal of the batch, and the corrective and preventive measures adopted. The Directorate may also order a withdrawal, stating its reasons, on alerts received from recognised international bodies, national or international authorities, or manufacturers in other countries (whether of raw material or finished product), or on results received from the Laboratorio de Control de Calidad de Medicamentos y Toxicología (CONCAMYT). · article: Numeral 6.13

In market surveillance of medical devices an Agency inspector may temporarily prohibit the manufacture, testing and marketing of medical devices for failure to meet the prescribed conditions or where public health is endangered; temporarily prohibit marketing of a device where the device is marked contrary to the Act and the regulations made under it; temporarily prohibit marketing of a device that does not meet the prescribed conditions or in other cases provided by the Act; and temporarily prohibit the operation of a legal person where the application of a quality system for the medical device is not ensured. The inspector may also order the removal of identified irregularities and defects.

Marketing of medical devices that are no longer in use or that are defective is not permitted. Medical devices that are no longer in use are disposed of at the cost of the owner or of the legal or natural person with whom the device was found. Medical waste must be disposed of in a manner that does not endanger the life and health of people or the environment.

Where the holder of a market authorisation becomes aware of a safety, efficacy or quality problem that could have detrimental effects on public health, the holder must, in consultation with the Authority, recall the medicine (and therefore the device). Contravention is an offence. The Authority may also recall a medicine or cosmetic without prior consultation with the authorisation holder.

BoMRA classifies recalls relative to the degree of health hazard presented by the product being recalled. Class I is for defective, dangerous or potentially life threatening products that predictably or probably could result in serious health risk, adverse events or death; Class II is for products that possibly could cause a temporary or medically reversible adverse health problem or mistreatment; and Class III is for products that are defective and unlikely to cause any adverse health reaction, or which do not comply with the requirements of the Medicines and Related Substances Act 2013 as to printed packaging material, product specification, labelling and the like.

The registration holder must initiate a field action as quickly as possible whenever there are sufficient indications or confirmation that a health product does not meet the applicable essential safety and efficacy requirements.

The registration holder must notify ANVISA of field actions per RDC 551/2021 Art. 9: 3 dias corridos for actions communicated through mass media and for serious threat to public health; 10 dias for serious risk; 30 dias for other actions.

Section 75(1) of the Medicines Act empowers the Authority to issue directions, in particular relating to the recall from the market and the disposal of any registered medicinal product, and s. 75(2) makes contravention an offence. The Act contains no recall, field safety corrective action or market withdrawal power over medical devices, and its seizure and forfeiture powers (ss. 60(4), 62 to 64) operate on articles connected with offences under the Act, which a device cannot be.

The Ministry of Health's Guidance for Medicinal Product Defect, Quarantine and Recall states that it applies to licensed manufacturers, wholesalers, importers and product licence holders for registered medicinal products and unregistered medicinal products imported via import permit on special approval, and reproduces the Medicines Order's exclusion of instruments, apparatus and appliances. Its recall classes (Class 1 to 3), recall levels and defect reporting forms (Annex II to IV) therefore do not apply to medical devices.

Manufacturers of devices made available on the Union market, other than investigational devices, must report to the relevant competent authorities any serious incident involving devices made available on the Union market and any field safety corrective action taken in respect of such devices, including any field safety corrective action carried out to prevent a risk of serious incident, in accordance with Articles 92(5) and (7).

When a dealer decides to initiate a field safety corrective action it must notify the Regulatory Authority; the time frame for that notification is prescribed by the Regulatory Authority of the Member State, and notification must not be delayed pending collation of distribution data. Reports are submitted in the authority's prescribed format, which may follow the ASEAN FSCA Report Form (Reference No. ASEAN MDFR). The action is closed only when all appropriate corrective actions have been undertaken, subject to the concurrence of the Regulatory Authority.

Where the Regulatory Authority ascertains that a medical device placed on the market, when correctly installed, maintained and used for its intended purpose, may compromise the health or safety of patients, users or other persons, it must take all appropriate interim measures to withdraw that device from the market or to prohibit or restrict its being placed on the market or put into service, and must immediately inform the other Member States, indicating the reasons for its decision.

A manufacturer or importer who decides to recall a medical device must give the Minister written notice of the decision and submit an initial report within 24 hours after making the decision.

The manufacturer or importer must provide the Minister, on or before the day the recall begins, a report on the reason for the recall, the defect, an evaluation of the risks, the quantity of devices distributed, and the proposed strategy for conducting the recall.

Field safety corrective actions (FSCA) must be notified to ISP using form ANDID/012 sent to tecnovigilancia@ispch.cl; customers must be informed through a Field Safety Notice (FSN) in Spanish, with a clear title (e.g. 'Retiro del Mercado'), identified recipients, device identification (model, lot, serial, expiry, manufacturer, country of origin), reasons/problem description and associated hazards. Market recalls must be communicated in writing to ISP immediately at the start of the recall process, and distribution records must be readily available to the manufacturer/importer/representative and to ISP on request.

Devices marketed or distributed by any title without the corresponding conformity verification certificate shall be seized (decomisados), without prejudice to other measures the health authority may adopt.

Where a registered/filed device fails mandatory standards or the registered product technical requirements, or has other defects, the registrant/holder must immediately stop production, notify operators, user units and consumers to stop operation and use, recall marketed units, take remedial or destruction measures, record and publish information, and report the recall and handling to the drug regulatory and health authorities.

Recalls are classified by hazard severity (Art. 13: Level 1 = possible/actual serious health harm; Level 2 = temporary or reversible harm; Level 3 = lower likelihood of harm but recall warranted). After deciding a recall, the manufacturer must notify operators/user units or users within 1 day (Level 1), 3 days (Level 2) or 7 days (Level 3). Level 1 recall notices are published on the NMPA website and central major media; Level 2/3 on provincial department websites (Art. 14). For recalls, the responsible manufacturer includes the China agent designated by the overseas manufacturer (Art. 3).

Importers must notify INVIMA of international alerts associated with devices they import within 72 hours of learning of the alert, together with the actions taken.

Manufacturers and importers must notify INVIMA of total or partial market withdrawals when products pose a risk to patients' health (Res. 4816 Art. 19); the manufacturer, registration titular or distributor must inform INVIMA when executing preventive measures or market alerts and when disseminating warnings related to devices (Decreto 4725 Art. 62).

Every recall (voluntary or Ministry ordered) must be executed within no more than 30 business days from identification of the problem unless the Ministry sets a different period (extensions requested before expiry; Ministry answers within 14 calendar days); the responsible party must submit a final report (form Anexo 2) within 20 business days after completion reconciling distributed and retrieved quantities with root cause investigation; for Class I/II recalls reaching user/consumer level, consumers must be informed through a public medium in the form, content and term set by the Ministry.

The Ministry may order market withdrawal of products of sanitary interest that fail regulatory requirements or pose a public health risk, evaluate recall scope/classification/timeframes, inspect or audit recall effectiveness, and for imported/exported Class I/II recalls exchange information with international authorities. Separately, on knowledge of any adverse or harmful event endangering public health related to EMB use, the Ministry may order market withdrawal as a precautionary measure, suspend or cancel the registration, and bar imports (Decreto 43902 S Artículo 3º; Ley 5395 arts. 355/356/362 basis cited in Decreto 43896 S).

Any voluntary recall meeting Class I or Class II criteria must be notified to the Ministry using the website form signed as sworn declaration, within a maximum of 5 business days from identification of the problem, defect or situation; the responsible party must adopt the recall measure and communicate it to the other establishments in the commercialization chain within a maximum of 5 business days.

The competent authority of each UEMOA member state must set up a market surveillance system for medical devices including in vitro diagnostics, referring to the AMDF and WHO guidelines. The system must comprise: an import/export control; a quality control; a control of promotion and publicity; a plan to combat counterfeiting, falsification and illicit sale; an inspection of the various actors in the supply chain; and a vigilance component. The competent authority must also put in place a mechanism for the safe management and disposal of non functional or end of life medical devices.

The AIRP has adopted Décision n° 0006 AIRP du 26 février 2026 fixing the modalities of batch recall and/or withdrawal, suspension and destruction of substandard and falsified pharmaceutical products (published on the AIRP official document index on 4 March 2026). It is the AIRP's current recall/field safety correction instrument: on detection or well founded suspicion of a substandard, falsified or defective product the AIRP may by reasoned decision order an immediate total or partial recall of one or more batches or of all stocks at every stage of the distribution chain, and the definitive withdrawal of any medical product whose benefit/risk ratio is found unfavourable (art. 3); marketing authorisation holders, manufacturers, importers and distributors must carry out recalls ordered by the AIRP at their own cost, notify the AIRP without delay and at the latest within twenty four (24) hours of any suspicion or finding concerning a substandard, falsified or defective medical product, and send the AIRP a documented final recall closure report (art. 4); falsified or dangerous products may be seized and destroyed under AIRP supervision at the holder's, manufacturer's or importer's cost (art. 5); the AIRP publishes recall/withdrawal/quarantine notices on its website and, where applicable, the WHO GSMS portal (art. 6); breaches expose the author to administrative sanctions without prejudice to criminal proceedings (art. 7).

Manufacturers must report to the relevant competent authorities any field safety corrective action in respect of devices made available on the Union market, including a field safety corrective action undertaken in a third country in relation to a device also lawfully made available on the Union market where the reason is not limited to the third country device. In Croatia the competent authority for these reports is HALMED, which conducts device vigilance under Article 19(1) of the implementing act. Except in urgent cases, the field safety corrective action must be reported in advance of being undertaken.

Inscribed suministradores must have procedures to communicate to the market the field safety notes (notas de aviso) issued by the manufacturer and the market withdrawals (retiros del mercado) carried out by the manufacturer. CECMED may cancel a marketing authorization where there are complaints about safety or performance problems, or for devices with quality problems or falsified devices, which may be retained, withdrawn, destroyed or dismantled; it also applies sanitary safety measures for non compliance (E 132 25 epígrafes 3.52, 3.61).

CYMDA's market surveillance actions include the recall of non compliant products from consumers, the withdrawal of products from the market, the destruction of dangerous products and the imposition of fines or other sanctions, and it exchanges information and data through the vigilance system so that other countries can take comparable safety measures.

Where non compliant products are identified, CYMDA may impose administrative measures and/or fines under Cypriot Law 225(I)/2022 on market surveillance.

CYMDA states that during its physical inspections the absence of the importer's details (where required), incomplete labelling by the manufacturer, and the absence of instructions for use in Greek (where required and where the product is intended for non healthcare professionals) make the medical device non compliant with the MDR/IVDR; the notice continues that its import and/or movement is an infringement of Article 5(1) and may lead to the imposition of fines.

SÚKL publishes, via ISZP, field safety notices (FSN) sent by the manufacturer, authorised representative or distributor to users in connection with an FSCA carried out or to be carried out in the Czech Republic. Transitionally (§ 74(11)) publication runs through RZPRO until ISZP; SÚKL guidance ZP 23 (2025) still points users to the FSN list at www.rzpro.cz.

Manufacturers report field safety corrective actions (FSCA) to SÚKL by an electronically filled form signed with a recognised electronic signature (based on MEDDEV Field Safety Corrective Action Report Form v2.7en of 3 December 2012), submitted simultaneously in PDF and XML, via the web interface, data box qwfai2m, or urgent@sukl.gov.cz / posta@sukl.gov.cz. Except in urgent cases, the manufacturer must notify the FSCA without undue delay and before it is carried out.

SÚKL inspects compliance with the obligations under Act 375/2022 Sb. and the directly applicable EU legislation in the devices area; SÚKL may impose fines by decision and decides on preventive measures under MDR Art. 98 / IVDR Art. 93 (§ 52).

As part of its control, the Danish Medicines Agency can issue injunctions and prohibitions against actors it supervises (manufacturers/authorised representatives, distributors, importers, notified bodies, investigation sponsors), including — under the authorization in lov om medicinsk udstyr § 1(2)(7) — orders for withdrawal from the market (tilbagekaldelse), buy back (tilbagekøb) and remedying of risks or defects, and demands for sample devices and documents.

Field safety corrective action notices (MDR Art 87(1)(b)) must be sent to the Danish Medicines Agency for devices on the Danish market; per DKMA guidance, an FSCA must always be reported to the authority of the country where the manufacturer/authorised representative is established and to all affected countries' authorities, and DKMA issues the NCAR report within 14 days of receiving FSCA information; the manufacturer must also submit a final FSCA report with results per country.

The Danish Medicines Agency may order a marketing responsible manufacturer (or its representative) to publish, or send to a defined circle of health professionals or hospitals, information about a device serving patient safety purposes, including information about suspected incidents; DKMA may set requirements for form and content and a deadline for publication/distribution. Non compliance is punishable.

statement: DIGEMAPS maintains a public 'Alerta Sanitaria de Seguridad' register through which it publishes numbered sanitary alerts and market withdrawals (alerts numbered FVA YYYY NNNN) covering medicines, food and medical devices. The register is the publication channel for field safety corrective actions, including the 26 March 2026 withdrawal of the Ivascular Navitian coronary microcatheter under alert FVA 2026 0004, announced as a voluntary field safety corrective action by the manufacturer and its Dominican distributor, for which DIGEMAPS listed the eight affected lots with their expiry dates and directed health professionals and health establishments to report suspected adverse events to its farmacovigilancia address. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

Suspension or cancellation of a device registration implies prohibition of manufacture, import and export, immediate market withdrawal and seizure of the product (per the Ley Orgánica de Salud). A holder requesting voluntary cancellation must file the request, the appointment document and a market withdrawal strategy per ARCSA instructivo; ARCSA reviews within 60 days and cancels all associated pending applications; voluntary cancellation is free of charge.

All establishments manufacturing, importing, distributing and marketing devices must have written market withdrawal procedures and a strategy for rapid, effective recalls; the manufacturer and/or registration holder must notify ARCSA in writing immediately at the start of a withdrawal, keep electronic distribution records available to ARCSA, monitor and record withdrawal progress, issue follow up reports on ARCSA request, and deliver a final report reconciling quantities delivered, consumed and returned; withdrawn products must be returned to the holder/manufacturer for destruction through authorized waste management channels, with destruction certificates and dispatch guides. Withdrawal may be voluntary, triggered by a sanitary alert, or mandated by ARCSA (obligatory recall).

Where a market placed device fails to perform per its IFU and the failure might lead to death or serious deterioration, the manufacturer/authorized representative must initiate an FSCA and report it to MDSU in advance (except urgent recalls), notifying all affected countries simultaneously. FSNs must be reported to MDSU within 2 5 days of issuance with an FSCA implementation plan; MDSU issues an approval letter permitting FSN distribution (urgent recalls may distribute first), and periodic implementation reports are required if the FSCA exceeds 90 days.

When a scientific committee issues a one year decision requiring re evaluation, the applicant must submit a signed and sealed list of hospitals supplied with the device so that the Medical Devices Safety Department can use questionnaires to verify safety and effectiveness and present the results to the committee.

For the state supervision provided for in the Medical Devices Act, the supervising authority may apply the special state supervision measures of §§ 30, 31, 32, 49 and 50 of the Law Enforcement Act (korrakaitseseadus) on the grounds and under the procedure set out there; the supervising authority is Ravimiamet and it may involve experts and commission conformity assessment testing of devices or their parts.

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

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

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

The manufacturer must ensure information about a field safety corrective action is brought without delay to the attention of users by means of a field safety notice, edited in the official Union language(s) determined by the Member State where the FSCA is taken; except in urgency, the draft FSN is submitted to the evaluating/coordinating competent authority for comments, content must be consistent across Member States unless justified, the FSN must identify devices (incl. UDIs) and manufacturer (incl. SRN), explain the reasons and risks without understating risk, and indicate all actions for users; the FSN must be entered in the electronic system (Art. 89(8) MDR).

Manufacturers must report to the relevant competent authorities any field safety corrective action in respect of devices made available on the Union market, including an FSCA undertaken in a third country in relation to a device also legally made available on the Union market if the reason for the FSCA is not limited to the device made available in the third country; reports go through the electronic system (Art. 87(1)(b) MDR).

Field safety notices under MDR Art. 89(8)/IVDR Art. 84(8) must be drawn up in the languages necessary for safety, and Fimea may order the manufacturer to prepare the notice in a specific language or languages free of charge; field safety corrective actions and notices are reported to Fimea through the incident channel (MIR/FSCA/FSN forms) until reporting via EUDAMED becomes possible.

For non compliant devices presenting a serious risk to health, safety, the environment or property, Fimea may order a service provider to remove content referring to the product from a website or other online interface, order a clear risk warning to end users, and — if not complied with — order blocking or restriction of access to the interface or removal of the domain name from use (or its transfer to Fimea); interim orders are possible and the parties must be heard first unless urgency prevents it.

Field safety corrective actions (actions correctives de sécurité) must be declared to ANSM in PDF and XML at materiovigilance@ansm.sante.fr; ANSM can order manufacturers to take corrective measures, may suspend or ban devices, and has financial sanctions available; field safety notices must additionally be registered in EUDAMED so they are accessible to the public.

Circulation of a product circumventing the regimes for granting a Georgian marketing authorisation, and/or circulation of a product that has not been granted a marketing authorisation in Georgia, is punishable by a fine of GEL 6,000 and seizure of the goods in violation; the same act committed repeatedly carries a fine of GEL 12,000 and seizure (Art. 37^5). Related offences in Article 37^4 of the same chapter cover the sale of substandard, expired or spoilt product (GEL 6,000 and seizure, para. 7), circulation of counterfeit product (GEL 20,000 and seizure, para. 8) and breaches of the procedures for register entry, manufacturing, standardisation, labelling, transport, import/export, re export, batch registration and destruction (GEL 1,600 and seizure, para. 9; repeated, para. 10).

Manufacturers with their seat in Germany must document the implementation of field safety corrective measures and regularly review their effectiveness; manufacturers, authorised representatives and importers based in Germany must notify the competent authority and the competent federal higher authority of the completion of a field safety corrective measure (importers only where the authorised representative is seated outside Germany).

Manufacturers must report field safety corrective measures in relation to medical devices (e.g. recalls) to BfArM in accordance with MDR and IVDR; BfArM operates the corresponding reporting channel ('Rückruf melden').

Field safety notices sent to users under MDR Art. 89(8) / IVDR Art. 84(8) in connection with field safety corrective measures must be drafted in German.

With effect from 10 January 2025, manufacturers are obliged, under Art. 10a MDR respectively Art. 10a IVDR, to notify interruptions or terminations of the supply of a medical device that is not a custom made device; in Germany the notification is handled via BfArM ('Anzeige Unterbrechungen oder Beendigungen von MP Lieferungen').

The local agent handles device recalls; the MDCHC Market Surveillance Department conducts post registration market surveillance operations for medical devices, recalls, retail outlet inspections/raids, and detention of non conforming goods.

Before implementing a field safety corrective action (FSCA) the manufacturer must send EOF: (1) nominal list of customers to be informed with full contact details, (2) description of the proposed FSCA and implementation timetable, (3) the Field Safety Notice (FSN) in the GREEK language to all customers, dated, with a signature/acknowledgement space or separate customer acceptance form (signed FSN to be returned to the manufacturer and kept on file). After completion: a consolidated list of all informed customers (dates of sending/acknowledgement, responsible person, date of action at customer site, units/lots withdrawn), preferably in the EOF oversight table format. All original supporting documents must be kept at the Greek premises of the manufacturer/authorized representative/distributor and be immediately available to EOF inspection; corrective action/recall information is submitted to EOF's Τμήμα Ελέγχου Κυκλοφορίας (market surveillance@eof.gr).

The DRCPFA maintains and publishes a register of notifications of complaints or claims, deviations (thefts) and withdrawals of product from the market, covering 'productos farmacéuticos, afines y otros productos objeto de vigilancia sanitaria'. The register carries medical device and in vitro diagnostic lines under their own sanitary registrations (PMQ for devices, RD for diagnostic reagents), each with the product, company, notification type, reason, lot, expiry and a completion status — for example the BD INSYTE N AUTOGARD IV safety catheter (registration PMQ 6304, lot 4208538, withdrawn 04/09/2025 for complaints during insertion, status FINALIZADO) and the BD BACTEC MGIT 960 PZA KIT (registration RD 5685, lot 3191569, withdrawn 04/07/2025 for false negatives in pyrazinamide resistance testing, status FINALIZADO). A product found non compliant in surveillance is therefore taken off the Guatemalan market through a published withdrawal notification that covers devices and IVDs, not only medicines.

Upon issuance of product recalls or field safety notices by the manufacturer or overseas authorities, the LRP must inform MDD of details and Hong Kong actions as soon as possible and not later than 10 calendar days after issuance, submit progress reports until conclusion, and preferably pre arrange email of the notice within four hours of manufacturer issuance.

NNGYK issues Free Sale Certificates (FSC) and English language certificates for devices manufactured in Hungary and distributed outside the EU (contact fsc@nngyk.gov.hu; fee per fee table item II.6).

Market surveillance (piacfelügyelet) of medical devices and IVDs in Hungary is a statutory duty of the NNGYK Medical Device Department.

Breach of the Icelandic Act's provisions on, among other things, safety requirements, CE marking, claims, labels and instructions for use, safe handling, user training, clinical investigations, manufacturer duties, manufacturer surveillance, importer duties, distributor duties, registration of implantable devices, and serious incident notification, carries fines or imprisonment for up to two years unless a heavier penalty applies under other law. Fines may be imposed on a legal person even where no guilt is proven against its representatives or employees. Where a party does not comply with a direction within a set time, Lyfjastofnun may impose daily fines until the position is remedied, up to ISK 50,000 per day; unpaid fines accrue default interest after 30 days.

Lyfjastofnun may by reasoned decision withdraw, recall or remove from the market a device, or prohibit its sale or supply, where it does not meet the rules and requirements for medical devices — safety, marking, instructions, certificates, declarations of conformity or test and inspection reports — and no other, milder remedy can be applied. Where an operator demonstrably obstructs an investigation or supervision, or does not give the agency sufficient information on device safety, the agency may withdraw, recall or remove the device or prohibit its sale or supply until the investigation is complete.

A manufacturer or authorised agent who has reason to believe a placed device may be unsafe must immediately initiate procedures to withdraw it from the market and patients, indicate the reasons and inform the competent authority; where the CLA is satisfied a device does not conform, it may direct that the entire batch (or more than one or all batches) not be sold or be recalled, including from hospitals where stocked.

Health supplies not meeting safety/benefit/quality standards or labelling requirements must be withdrawn from circulation by the izin edar holder and/or business operators, either on the order of the Minister (for devices) or on the operator's own initiative. Recall triggers include sampling/testing results, complaint verification, inspections, the rapid alert system, an izin edar that expired without extension, and revoked izin edar or EUA. The recalling operator must document the recall and report it to the Minister through the integrated health information system; recall procedure (tata cara) for devices is set by the Minister.

TTAC provides a rapid reaction and recall system for non conforming health products nationwide; the directorate also publishes recalls ('فراخوان Recall') and safety notices/alerts (اطلاعیه‌ها و هشدارهای ایمنی) as public sections on imed.ir.

COSQC's remit includes limiting the inflow of low quality goods by inspecting imported goods and monitoring the quality of local products (market surveillance under Law 54/1979).

HPRA market surveillance enforcement tools under S.I. 261 of 2021 include quarantine notices, compliance notices and prohibition orders (regs. 31 33); an appeal against a compliance notice appeal decision lies to the District Court not later than 7 days after the decision, and a prohibition order may be appealed to the Circuit Court in the circuit where it was served not later than 7 days after service.

AMAR publishes a list of recall notices (קריאות להחזרה) for medical devices on its site; the law empowers the Director General to order marketing restrictions and recalls of registered devices (Chapter C of the law, in the official text held).

Where a violation is ascertained, the Ministry orders the manufacturer, mandatario and all interested economic operators to take every suitable action to end the infringement within a clearly defined term, at the recipient operator's care and expense (Art. 19(9)); if the term lapses unfulfilled, the Ministry adopts adequate measures to ban or restrict making the device available on the national market, withdraw it or recall it, at the expense of the recipient operator (Art. 19(10)). The measures apply also where CE marking was improperly affixed to products outside the MDR (Art. 19(11)).

Market surveillance of the decree is delegated to the Ministry of Health, which may order checks via its central and peripheral offices and specially appointed entities; checks may be carried out on a sampling basis at economic operators, suppliers, sub suppliers and professional users, including access to premises, acquisition of documentation and free sampling or device access for testing (Art. 19(3) (4)).

MHLW or prefectural governors may order persons handling devices to dispose of, recall, or take other measures sufficient to prevent public health danger (e.g., defective devices, products whose approval was revoked).

Recalls by MAHs/foreign special approval holders are reported promptly after initiation to MHLW (or prefectural governor where delegated) with specified items (recaller, product identifiers incl. approval/certification/notification numbers, lots/quantities, sites, export destinations, initiation date, method, planned completion, further measures), plus change reports and prompt completion reporting.

The Follow up and Audit Section of the Medical Devices and Supplies Directorate carries out withdrawal of batches (تشغيلات) of medical supplies and cosmetics from the local market and takes corrective action measures for medical supplies and cosmetics.

Medical supplies, sterilants, disinfectants and cosmetics on the market are subject to post marketing testing; if a product fails testing and a decision banning its circulation is issued, the batch is withdrawn in accordance with instructions issued for that purpose.

In urgent cases of protecting users or third persons from threat of death or serious health deterioration the manufacturer/authorized representative performs corrective actions; a safety notice (уведомление по безопасности) is the communication sent by the manufacturer/representative to circulation subjects in connection with a safety corrective action.

The authorized body may suspend or prohibit use, sale or production and decide withdrawal from circulation or restriction of use of devices on grounds including design/production defects affecting safety, harm to health, the holder's own application, and failure of monitoring obligations.

Regulatory actions taken by the Board on device safety may include recalling the device, reclassifying it, or ordering a redesign from the manufacturer or another; the Board may request the MAH to conduct a concise critical analysis of the device's safety and performance and submit results within a specified time frame, and issues safety alerts and advisories to healthcare professionals on serious adverse incidents and FSCAs. PPB market surveillance protects public health through timely regulatory actions including recalls, alerts and withdrawals, with products sampled and tested in accredited labs.

The manufacturer must report to PPB in a timely manner, directly or through its authorized representative, any Field Safety Corrective Actions it is undertaking within Kenya; Field Safety Notices and FSCAs, including those based on incidents occurring outside Kenya, must be submitted in periodic summary reports with full details of vigilance issues and FSCA status, completed using the current WHO FSCA and FSN reporting template. The MAH must disseminate the FSN to all relevant stakeholders only after obtaining approval from the Board.

statement: The Health Inspectorate may suspend the placing on the market, distribution or use of a device where it classifies the device as unsafe or dangerous and its further use endangers the health or life of a patient, user or third person. It may require the holder or keeper of a device to take corrective action to secure conformity, and may require corrective action where distribution or operation does not comply with the regulation or Regulation (EU) 2017/745. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: postmarket surveillance · localApplicationRequired: No · targetDecisionRetained: Yes

Where the MOPH detects fraud or misleading information supplied by a supplier or any party in the medical device supply chain, it reserves the right to carry out the necessary investigations and take adequate action: suspending or cancelling the registration of the device on the LNDMI list, and withdrawing the device in question from the market.

Under the HMG the Amt für Gesundheit is responsible for post market control of medical devices in particular in retail and dispensing points, craft manufacture of custom made devices, systems and procedure packs, and maintenance and reprocessing of devices at the applying professionals.

Market surveillance measures taken by Swissmedic or the Amt für Gesundheit each apply to the whole customs territory (Switzerland/Liechtenstein); the seat of the addressee determines which authority is competent, the Amt für Gesundheit being an independent enforcement authority. Swissmedic informs it of general rulings issued to protect the population, and the Amt für Gesundheit reports events like the cantons do.

On learning that devices do not meet the requirements of Regulation (EU) 2017/745 or 2017/746, the responsible economic operator must immediately stop placing them on the market, recall and/or withdraw them from the market, inform VASPVT, potential users and related market subjects, and take other necessary measures to eliminate the danger.

Market surveillance of medical devices is the responsibility of the Direction de la santé, acting through the Division de la pharmacie et des médicaments (DPM), whose functions include inspecting and regularly controlling the informal market, including e commerce, to prevent illegal trade in health products; from 28 May 2026 EUDAMED market surveillance use is mandatory.

Registration holders and filers must establish and operate product traceability and recall systems and notify ISAF of recalls promptly; ISAF may order recall of all or part of a device batch and temporarily prohibit or restrict manufacture, import/export, wholesale or retail of the device, with sealing, seizure and destruction as last resort.

The establishment shall submit a recall report to the Authority within 30 days after completion of the recall, covering the circumstances leading to the recall and consequent actions; under section 42(3) Act 737 the outcome and preventive actions must be reported as soon as possible after completion.

The establishment must notify the Authority and all affected persons on or before initiating a recall, within the class based timeframe: Class I recall (high risk, serious health consequences or death probable) within 48 hours; Class II (medium risk) within 3 working days; Class III (low risk) within 5 working days. Statutorily, section 42(2) Act 737 requires information to be given to the Authority on or before conducting a recall, and the Authority may order a recall at any time for patient safety or public health.

Every economic operator must keep a register containing details of complaints, of non conforming devices and of recalls and withdrawals, and must keep the competent authority informed of that monitoring. On the Union side, manufacturers must report any field safety corrective action in respect of devices made available on the Union market, including a corrective action taken in a third country on a device also lawfully made available in the Union where the reason for it is not limited to the third country device. The Malta Medicines Authority maintains a repository of medical device field safety notices for devices available in Malta, monitors their dissemination, tracks implementation of corrective actions and reports on them.

Sanitary safety measures under LGS Art. 404 include seizure and destruction of objects, products or substances and suspension of advertising messages; suspension of production or commercialization of insumos must be communicated to the authority within 30 working days of occurring, stating causes, and restart within the following 10 days (RIS Art. 36); exporters must report foreign sanitary rejections of exports within 5 days with product identification, lots and cause (RIS Art. 152), and re entry of rejected goods requires an import permit.

AMDM issues and publishes orders withdrawing specific medical devices from the market of the Republic of Moldova, identified by device, lot number and manufacturer, and maintains a list of the medical devices withdrawn from the market. The published examples on the agency's page are withdrawal orders for peripheral intravenous catheters of a named manufacturer and lot numbers, issued under the AMDM order series A07.PS 01.Rg04.

AMDM maintains a separate page of orders prohibiting the use of medical devices, published alongside the withdrawal orders in the "management and supervision of medical devices" section of its site. The orders published there are issued device by device and identify the device, the manufacturer, the country of manufacture and, for prohibitions of use, the device's registration numbers in the State Register of Medical Devices for example an order of 31.05.2024 prohibiting the use of peripheral intravenous catheters of a named Indian manufacturer under RSDM registration numbers DM000373399 and DM000373398, and a withdrawal order of 11.03.2026 for two named ophthalmic surgical devices of another Indian manufacturer.

Where laboratory analysis shows that medicines, vaccines, biological products or medical devices fail the requirements, are unregistered, or may be counterfeit and may cause a serious risk to human life, they must be recalled within 24 hours; where they may pose a short term health risk, within 72 hours; and where the probability of health risk or adverse effect is low, within 14 days. Recalls are carried out from health organisations, supply organisations and consumers under Art. 20.6, and the supplying organisation bears the cost of testing and of recall where requirements are not met.

If the Agency establishes that a medical device conforming to the essential requirements, or a device made to order for a particular patient, when correctly installed, maintained and used in accordance with its intended purpose, may endanger the health or safety of a patient, user or other person, it proposes to the health inspection that trade in or use of the device be suspended or prohibited, or that the device be withdrawn from the market in accordance with the Law and with the law governing inspection supervision. The health inspection must notify the Ministry and the Agency of the measures taken without delay.

The Agency publishes on its website the notification of the measures and activities undertaken in connection with a serious risk that a medical device poses to public health and to the safety of users. The Ministry prescribes in more detail the conditions for the procedure of suspension or withdrawal of a medical device from trade, as well as the periods and manner of notification of suspension and withdrawal.

The health inspection is obliged to prohibit trade and order the withdrawal of a medical device, or a particular batch of a medical device, from the market in the cases set out in Article 7 of the Law and also where: the device is harmful under normal conditions of use; it does not meet the performance requirements; the risk benefit ratio is unfavourable under the approved conditions of use; its qualitative and quantitative composition does not correspond to what is declared; the prescribed conformity assessment procedures were not carried out by a notified body; or in other cases where the device is on the market contrary to the conditions prescribed by the Law. Most of those grounds operate on a proposal of the Agency or on a notification received from a notified body.

If the manufacturer, the wholesaler or the importer decides to withdraw a medical device, or a particular batch of a medical device, from the market, it is obliged to notify the Agency of that without delay. Responsibility for withdrawing a device from the market and for taking measures to prevent it being placed on the market lies with the importer of that device, as well as with the person responsible for vigilance at the importer.

Where it appears to the administration that a device may present risks to public health, it immediately notifies the registration holder and invites observations within fifteen days. On the holder's response, or in default of a response within that period, the administration may, after consulting the national consultative medical device commission, order the holder to cease distribution immediately and to recall the devices placed on the market. In an emergency it suspends the registration by reasoned decision and orders preventive withdrawal from the market for fifteen days from the date of suspension until a final decision, which must be taken under the same procedure within sixty days of the suspension. A device may also be permanently withdrawn from the market by decision of the administration on the reasoned request of the registration holder.

Field safety corrective action, including repair/modification and market recall, is an established DFDA post market measure for medical devices.

Field safety corrective actions (FSCA) with the field safety notice (FSN) are reported to the IGJ using the FSCA form, sent by email to meldpunt@igj.nl (as PDF attachment), until EUDAMED is fully functional.

The Minister of VWS is empowered to take the special measures for the protection of public health referred to in MDR art. 98(1) (and the IVDR equivalent), such as requiring recall or withdrawal of devices.

Recalls and other corrective actions should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code (latest edition in effect from 1 December 2015). Sponsors should discuss the issue with Medsafe before initiating any recall or non recall action, provide progress reports, and submit a final closure report; Medsafe should also be advised of post market actions for safety reasons on exempt devices.

An FSCA is triggered by incidents with distributed devices posing an unacceptable increase in risk (malfunction/deterioration, inadequate information, undesirable side effects); FSCA actions include device recall (return to manufacturer/representative), modification, exchange, destruction, or use advice; an FSCA is communicated through a Field Safety Notice (FSN), and manufacturers report any FSCA to the Agency as required by the Medical Devices Regulations.

Manufacturers (or MAHs) must send NAFDAC an investigation report: Serious Public Health Threat immediate, not later than 48 hours; Death or Serious Deterioration in Health as soon as possible, not later than 10 calendar days; Potential Death or Serious Deterioration not later than 30 calendar days.

Breach of the device provisions of the Law — including labelling and instructions for use contrary to Article 132 — is punishable by a fine scaled to the size of the legal entity: 2,500 to 3,000 EUR for a micro entity, 5,000 to 6,000 EUR for a small entity, 15,000 to 18,000 EUR for a medium entity and 25,000 to 30,000 EUR for a large entity. The responsible person in the legal entity is fined 1,200 to 1,500 EUR and the employee 500 to 750 EUR.

Market surveillance is exercised through the pharmaceutical inspector's measures: a ban of up to six months on manufacture, testing or placing on the market, an order to align operations with the Law, a prohibition, an order to destroy the device, temporary withdrawal or seizure of the device, a ban on import, and a temporary ban on the legal entity's work. A second measure under the same article is a ground for revoking the entity's licence and erasing it from the register.

The holder of a parallel import approval must notify the Agency within 15 days where the device is withdrawn from circulation in the source country, and the Agency revokes the approval on that ground. Independently of the administrative penalties, submitting false data, a false statement or false proof in the procedure for entering a device in the register, or in the procedure for obtaining a parallel import approval, is a criminal offence punishable by six months to five years of imprisonment.

Reports on field safety corrective actions and the field safety notice for devices on the Norwegian market or from Norwegian manufacturers shall be sent to the Norwegian Medical Products Agency (NOMA) by email to MSOD@dmp.no; NOMA responds with a case number that must be stated in all subsequent communications.

Safety communications from manufacturers to users of devices must be given in Norwegian; in special cases they may be given in English until a Norwegian translation is available, and the Norwegian translation must follow without undue delay.

FSCA is defined as an action taken by the manufacturer to limit or reduce the risks compromising the safety of a medical device or supply; the Medical Device Vigilance Section evaluates corrective/preventive actions and the Medical Devices Control Department issues Field Safety Notices and alerts or recalls related to medical devices and coordinates action across departments.

Under rule 31(c) and (d), an export permit holder informed by the MDB that part of a batch or lot has been found by the Authority not to conform to required specifications must, on direction, withdraw the remainder of that batch or lot from export and, so far as practicable, recall the issues already made from that batch or lot, and must maintain a record of all exports for each batch or lot. Rule 32(b) imposes the same withdrawal and recall duty on exporters generally for contraventions of the DRAP Act or the rules.

DNDM may order retention of devices found in non compliant establishments and their seizure (decomiso) by reasoned resolution. Fines range from B/.500 to B/.5,000 (minor faults), B/.5,001 to B/.50,000 (grave) and from B/.50,001 upward (gravísima). Re packing, re labelling and re conditioning of devices is prohibited.

DINAVISA may establish the measures necessary to minimise the risks associated with the use of medical devices so as to maintain an adequate benefit/risk balance, and may base those regulatory measures on the decisions of reference regulatory agencies.

For IVDs registered through the simplified process, DINAVISA may suspend or cancel the sanitary registration, prohibit commercialisation, distribution, import, export and elaboration, and require withdrawal from the market, and may initiate the corresponding administrative proceedings.

Manufacturers' corrective actions (ASC acción emprendida por un fabricante para reducir el riesgo de death or serious deterioration of a patient's health) are notified through a 'Nota de Seguridad en Campo'; CENAFyT coordinates processing, including VigiFlow based management, and the ANM publishes alerts on unsafe products (Ley 29459 Art. 37).

All retailers of medical devices must immediately stop the sale of devices banned or withdrawn for health and safety reasons in the country of origin, and those declared by FDA to be unregistered, counterfeit, injurious, unsafe or dangerous.

An economic operator that placed on the market, put into use or imported a device must notify users of threats related to devices, systems or procedure packs in a manner adequate to the threat, including through mass media; if it fails to act or acts inadequately, the President of URPL may act in its place at the operator's cost.

Where a device presents a risk (MDR Art. 95(4)/IVDR Art. 90(4)) or in the safeguard situations (MDR Art. 97(2), 98(1)/IVDR Art. 92(2), 93(1)), the President of URPL issues an administrative decision prohibiting or restricting availability or withdrawing the device from the market or from use; decisions are published in BIP and copies go to the health minister; if the Commission finds the decision unjustified, URPL must revoke it within 30 days.

Until the EU implementing act under MDR Art. 91(d) is adopted, manufacturers must submit the field safety corrective action report and the safety notice to INFARMED up to two days before the date proposed for the start of the action, except in cases of serious public health threat.

To protect health, safety or MDR conformity, INFARMED may adopt necessary and transitional measures regarding a device or category of devices (including usage guidance and special monitoring); where non conformities can be remedied, it may impose special conditions or duties and set a deadline for regularisation.

As competent/market surveillance authority ANMDMR carries out announced and, where necessary, unannounced inspections, including physical controls of products; complaints can be filed at sesizaridm@anm.ro.

Obstruction of market surveillance inspection is sanctioned with a fine from 5,000 to 10,000 lei under art. 935(1)(g) of republished Legea 95/2006.

On confirmation of a threat, Roszdravnadzor decides to suspend circulation of the device and take samples, and may decide to withdraw the device from circulation with information letters published on its official website; withdrawal and destruction are governed by Government Decree No. 145 of 2022 and federal state control by Government Decree No. 1066 of 2021.

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

Devices may not be traded if SFDA decides to recall them or ban their trading. On harm, misleading claims or safety impact, SFDA may seize devices, temporarily close an establishment, suspend licenses, take samples for testing at the establishment's expense, issue and publish safety alerts, ban circulation, stop production lines, and order destruction at the violating establishment's expense.

For FSCAs affecting KSA, the manufacturer or AR must report to NCMDR within 2 days of the FSCA letter issue date (attaching the letter); respond to SFDA/NCMDR inquiries within 5 days; notify affected users (importers, distributors, healthcare providers, users) within 5 days; submit the implementation plan within 5 days; and submit periodic reports to SFDA if implementation exceeds 90 days.

Any device marketing authorisation may be suspended. Suspension is imposed for a determined period where there is a suspicion of danger to public health or where the device actually presents a danger to public health. The suspension decision is taken by the ARP's Director General and notified to the marketing authorisation holder, who may supply any necessary information. Lifting of the suspension may be requested from the competent authority where, within six months of notification of the suspension, withdrawal of the authorisation has not been pronounced. Any marketing authorisation may be withdrawn where the device actually presents a danger to public health; the withdrawal act is pronounced by the ARP's Director General and notified to the holder.

The manufacturer/AR must notify ALIMS without delay of any initiated Field Safety Corrective Action (FSCA). The manufacturer/AR and the wholesaler must have a plan for urgent withdrawal of devices from the market ensuring effective withdrawal at the request of the Ministry, the manufacturer or the AR.

The Ministry prohibits marketing and orders withdrawal of a device if it is harmful in normal use, fails its performance, has an unfavourable benefit risk ratio, deviates from prescribed composition, lacks conformity assessment, is produced by an unregistered/unlicensed entity, has no registration request or certificate of conformity, is forged or suspected of forgery, has passed expiry, or is otherwise on the market contrary to law (whole device or a series). Withdrawal may also be ordered based on notices received through the EU/EEA rapid information exchange system or PIC/S. The wholesaler must withdraw devices subject to a ban. A manufacturer/AR deciding voluntarily to withdraw a device or series must inform the Ministry and ALIMS without delay.

The FSCA MDRR1 Notification Report should be submitted before the initiation of the FSCA or stock recovery in Singapore. An FSCA that falls under MDRR3 reporting should be submitted within 30 days of initiation in any country globally. There must not be undue delay in initiating the FSCA in Singapore once the product owner has initiated it globally.

A manufacturer must notify the Authority of the intended field safety corrective action before carrying out any FSCA; the Authority may require a public statement; offences up to $10,000/6 months ($20,000/12 months for false information).

A manufacturer, importer, supplier or registrant who intends to recall a device must notify the Authority of the intended recall at least 24 hours before the time of the intended recall; the Authority may require inspection and a report; offences up to $10,000/6 months.

Notification 'before carrying out the recall' is satisfied by submitting as much recall detail as is known within 24 hours of the decision to recall. A preliminary report with full information must be submitted within 24 hours from commencement of the recall, and a final report within 21 days from the date of commencement, in the manner HSA prescribes.

The ŠÚKL medical device vigilance system serves to report, record and evaluate serious incidents (MIR) and field safety corrective actions (FSCA) with the aim of protecting patients and users. ŠÚKL publishes national field safety notice forms: FSN SK for manufacturers and response forms for distributors (FSN odpovedny form distributor) and customers (FSN odpovedny form zakaznik).

JAZMP inspectors (pharmaceutical inspectors) supervise the field; on finding violations they may prohibit the business entity's activity, restrict/ban/condition making devices available, order withdrawal or recall of a device posing unacceptable risk, seize or destroy devices, ban a clinical investigation or performance study, suspend or revoke notified body designations, require data and take free samples; an appeal against inspector measures does not stay their enforcement.

The holder of a certificate of registration or licensee must submit a Field Safety Corrective Action report to the SAHPRA Medical Device Unit when correcting product already on the market, removing product from the market to facilitate corrections, or advising users of an issue relating to a medical device; FSCA notifications go to mdvigilance@sahpra.org.za.

Recalls must be communicated to recalls@sahpra.org.za (Regulatory Compliance Unit) and must NOT be communicated to the Medical Device Unit; SAHPRA publishes recall notices for medical devices.

The Enforcement Rule prescribes official recall forms: recall plan (회수계획서, [서식 43]), recall confirmation (회수확인서, [서식 44]), recall evaluation report (회수평가보고서, [서식 45]) and recall termination report (회수종료보고서, [서식 48]).

MFDS (or the listed local government heads) order manufacturers etc., by hazard degree, to suspend sales, recall, dispose of by public health protective means, or take other measures, and may publicise the fact; the standards, methods and publicity methods for hazard degree based suspension/recall/disposal are delegated to the Prime Ministerial Decree.

Manufacturers must inform AEMPS of any field safety corrective action before the action is carried out (per MDR arts. 87.1 and 88), and the safety note must be sent to AEMPS before its diffusion and be provided in Spanish; the identical rule for IVDs is in RD 942/2025 art. 30.6.

AEMPS and Spanish administrations exercise market surveillance and inspection over devices per Articles 108.2 and 108.3 of the consolidated Law of guarantees and rational use of medicines and medical devices (RDLeg 1/2015), and adopt corrective measures independently of any sanctions; inspectors may request any information needed to verify compliance.

NMRA initiates recalls of any medicine, medical device or borderline product manufactured, sold, stored or distributed in, or imported into Sri Lanka that is unsafe or defective; it may also act on MDEC/MEC/BPEC recommendations and on safety alerts issued by the WHO or any other national regulatory agency, and can temporarily withhold a product where defectiveness is doubtful.

Recalls are classified by hazard: Class I (life threatening or serious risk) — cease sale/distribution within 24 hours and complete physical recall within 72 hours; Class II (mistreatment or harm, not life threatening) — up to 10 days; Class III (unlikely to cause harm, e.g. non compliance) — up to 30 days.

The marketing authorization holder shall voluntarily recall a product if any evidence appears casting doubt on its quality, efficacy or safety, and shall inform the Authority within 24 hours of initiating such voluntary recall; the MAH must recall every defective batch/product in circulation in Sri Lanka.

FSCAs and FSNs directed at Sweden must be reported to Läkemedelsverket. Manufacturers established in Sweden report to LV regardless of whether the affected products are or were provided in Sweden, and additionally to competent authorities of all EU countries where the products are or were provided; manufacturers outside Sweden report to LV if the products are or were provided in Sweden. The FSCA report is drawn up using the EU developed template and submitted via the e service in PDF and XML (separate Swedish template for NMI, updated 2026 02 09).

If a manufacturer or SPPP conducts a field safety corrective action involving devices available on the Swiss or Liechtenstein market, it must notify Swissmedic of the FSCA without delay. Field safety notices (FSN) directed at users or customers must be published on the Swissmedic website (www.swissmedic.ch/md fsca en), one machine readable PDF per language, with personal data redacted, under TPA Art. 67, MedDO Art. 90(g) and IvDO Art. 73(g).

From the announcement, legal determination or permit revocation date, medical care institutions and device firms must stop importing, manufacturing, wholesaling, retailing or displaying the devices for sale. Marketed and stock units are disposed of as follows: domestically manufactured devices that pass re inspection or testing may be reworked under local authority supervision within a deadline, otherwise they are confiscated and destroyed; imported devices are sealed immediately and the original importer must re export them within a set deadline, failing which they are confiscated and destroyed.

Distributors must maintain operating procedures for serious adverse event reporting (Act Art. 48(1)), Act Art. 49 notifications, corrective and preventive measures, and Act Art. 58 recall notices with deadline bound recall handling, and must evaluate the effectiveness of their recall operations at least once a year. Reporting, corrective action and recall handling records must be kept.

Recalls are graded: Grade 1 (serious harm or risk of serious harm to user health), Grade 2 (no harm / not serious harm), Grade 3 (revoked manufacturing permit and other listed cases). Completion deadlines: Grade 1 within one month, Grade 2 within two months, Grade 3 within six months from the day after announcement or the legally determined recall date. Direct customers must be notified within 24 hours (Grades 1 2) or one week (Grade 3), with notification records kept at least five years; after completion, a recall results report must be filed with the municipal/county authority and copied to the central authority within 3 days (Grades 1 2) or 2 weeks (Grade 3).

Where a licence is revoked, the device is defective or unregistered, or human health risk is suspected, the licence holder/filer must immediately notify medical care institutions, other device firms and pharmacies, and recall and handle marketed and stock products within prescribed deadlines; institutions and firms must cooperate. Where the authority re evaluates and finds safety concerns, it may order improvement and, if necessary, removal from shelves, recall, and suspension of manufacture/import/sale (Art. 50).

Licence holders/filers must adopt written recall operating rules covering the recall organisation, personnel and tasks, the recall plan, notification method, recall and handling method, and the results report. Before executing a recall, a recall plan (content including total quantities manufactured/imported, sold and in stock, per buyer distribution including exports, reason and potential harm, expected completion date and notification method) must be filed with the municipal/county authority and copied to the central authority, which may require amendments. Recalled products and stock must be identified, labelled and stored separately. After completion, a results report (quantities recovered/unrecovered, per counterparty detail, storage location, disposal method and date, preventive/corrective actions) goes to the same authorities.

The Market Authorization Holder must notify TMDA concerning field safety corrective action (FSCA), including recall, and must report defects and adverse effects to the Authority; handling device recalls is an applicant responsibility.

Where TMDA is satisfied that any regulated product is unfit for the intended use, it may seize, forfeit and condemn the product, declare it unfit and order its destruction at the owner's cost.

The Secretary General of the Thai FDA may order manufacturers, importers or sellers to recall devices from the market within a period the Secretary General prescribes; the operator bears the costs of the recall and any destruction or disposal ordered.

ANMPS's vigilance and market surveillance activity is organised by product family: « Matériovigilance » for medical devices, pharmacovigilance for medicines and cosmétovigilance for cosmetic products, together with « Gestion des réclamations » (complaint handling). Device market surveillance is therefore a distinct named activity of the agency rather than a branch of medicines vigilance.

Where a device is non compliant without presenting an unacceptable risk, the economic operator must end the non compliance within a reasonable period; if it does not, the Kurum takes all appropriate measures without delay to restrict or prohibit the device's availability or to ensure its recall or withdrawal, and notifies the Commission and authorities.

Where evaluation shows a device presents an unacceptable risk, the Kurum requires the manufacturer, authorised representative and other economic operators, within a reasonable period notified to them, to carry out appropriate, duly justified corrective actions: bringing the device into conformity, restricting its availability, subjecting it to requirements, withdrawing or recalling it; results are notified to the Commission and other authorities via the electronic system.

On the manufacturer's side, INS/GDL/047 s. 7.1.1.8 requires the manufacturer to determine product recalls and other field actions that are relevant for products already distributed, s. 7.1.1.7 requires relevant information on quality issues and on preventive and corrective actions to be submitted to the competent health authority when applicable, and s. 7.2.1.2 requires complaints to be notified to the competent health authority when applicable. DAR/GDL/028 s. 4.3.1(b) makes the authorised local technical representative fully responsible for the post market plan submitted for complaint handling or recall. On the Authority's side, reg. 31(1) of S.I. 2014 No. 29 allows NDA to suspend a registration by giving the holder written notice stating the reason, and reg. 31(2) requires suspension where the holder has contravened the Regulations or the Act, made a false or misleading statement in the application, failed to comply with the terms and conditions of the certificate, or where the instrument no longer meets the safety and efficacy standards NDA determines. Before suspending, NDA must consider the holder's compliance record and whether maintaining the registration would injure health or safety, and must give written notice of intention to suspend setting out the reason, the corrective action required and the time to take it (reg. 31(3)); it may not suspend before that time has elapsed or without giving the holder an opportunity to be heard (reg. 31(4)). Reg. 32 carves out an exception: NDA may suspend without a hearing where necessary to prevent injury to the health or safety of patients, users or other persons. Reg. 33 allows reinstatement where the situation that caused the suspension is corrected or the reason was unfounded, and DAR/GDL/028 s. 4.8 additionally allows NDA to revoke a registration or amend its conditions by giving reasons in writing.

Where a marking or other violation is not remedied, Держлікслужба or the customs authorities take measures to restrict or prohibit placing the device on the market and must satisfy themselves that the device is withdrawn from circulation.

Any complaint or report to withdraw a batch or the entire medical product, inside or outside the State, must be reported to EDE within no more than 15 days from the date of knowledge.

EDE may suspend circulation of a medical product where quality, safety or effectiveness is in doubt and must decide on withdrawal of the product or its batches within 30 days from the date of suspension.

Before taking a field safety corrective action (FSCA) the manufacturer must produce a risk assessment and submit to the Secretary of State an initial report and the proposed field safety notice (urgent FSCAs may be reported afterwards); it must then implement the FSCA as soon as possible, provide updates and evidence on request within 3 working days, and submit a final report after completion. The field safety notice must identify the devices (with unique device identifiers in searchable format), explain the reasons by reference to risks, describe actions users must take, and be sent to users of the device.

MHRA enforces through MMD Act compliance/suspension/safety/information notices and can recall a device if no alternative steps would sufficiently protect health or safety; enforcement starts with the MHRA Devices Compliance Unit contacting the person to explain concerns and request information, escalating where there is failure to co operate or a serious risk to public health, with site inspections and seizure powers available. Breaching a notice or the UK MDR is an offence punishable by imprisonment up to 6 months, or a fine, or both.

Manufacturers and importers must report to FDA a correction or removal of a device undertaken to reduce a health risk or to remedy a violation that may present a health risk, within 10 working days of initiating the correction or removal (21 CFR 806.10(a) (b)); reports must include the UDI (806.10(c)(5)), and duplicate reporting is not required where another party has reported (806.10(f)).

Where products are not fit for their intended use or may pose a danger to human health, definitive seizure is ordered and the products are destroyed at the infractor's expense.

The competent authorities will suspend the registrations of medical products where: a) non compliance with Art. 7 literal h) (change notification) is proven, or b) there are duly justified suspicions that the product presents risks to the health of the patient, operator or third parties.

If an inspected production site is found non conforming with the national ISO 13485 harmonized standard, certificates of devices previously manufactured and registered at that site are suspended; validity is restored only after all non conformities are eliminated, re inspection is passed with positive results.

Suspension, cancellation and termination of the registration certificate follow Articles 32 34 of the Law "On Licensing, Permitting and Notification Procedures"; a single gross violation of the registration requirements of para. 9 (sub paragraphs three four and six nine) is grounds for cancellation.

IMDA may suspend and terminate suspension of circulation of device batches (para 3 Art. 34) and order batch recalls (para 4 Art. 34) under Decree 98 as amended.

From Circular 44/2025, IMDA conducts specialized inspection (per para 1 Art. 6 Decree 217/2025/NĐ CP) over organizations performing classification, manufacture, circulation, trading, export/import, services, information/advertising, and use of devices.

For a Class I recall, the MAH, local responsible person, distributor and manufacturer must notify the public within 24 hours of the recall decision, quarantine undistributed stock immediately, and complete the recall within 72 hours. A problem that may lead to a Class I or II recall must be reported to ZAMRA by telephone within 24 hours (Appendix II note).

Recalls are classified by severity into Class I, II and III. Class I and II are 'Urgent Safety Related Recalls' that must be reported to ZAMRA for evaluation; Class III are minimum risk recalls that must nevertheless be reported. ZAMRA determines the class of each recall, and for international recalls it considers decisions of other national regulatory agencies.

Where there is non adherence to the Recall Guideline, ZAMRA institutes regulatory action and prosecution in accordance with s.46(4) of the Medicines and Allied Substances Act (fine up to one million penalty units and/or up to three years' imprisonment).

ZAMRA's Guideline on Recall of Medicines and Allied Substances (March 2023) applies to all quality defect reports and safety/efficacy incidents for medicines and allied substances, and to local responsible persons, MAHs, distributors, manufacturers, wholesalers, retailers, health facilities and the public; its definitions state that allied substances include medical and surgical sundries, medical devices and condoms.

Recalls must be initiated within 24 hours (Class I), 48 hours (Class II) or 72 hours (Class III), and physically completed within 72 hours (Class I), 14 days (Class II) or 30 days (Class III).

A ZAMRA inspector may, on the authority of a warrant, enter premises or conveyances believed to be used contrary to the Act and, among other powers, seize any medicine or allied substance (and related records or devices) that bears on an inspection or investigation or is used contrary to the Act, and take samples for testing, examination or analysis.

The MAH, local responsible person, distributor or manufacturer must give ZAMRA an interim progress report within 7 calendar days of initiating the recall, a final report within 14 calendar days of commencing it (or obtain ZAMRA's approval for a later date), and a report on the investigation results and preventive action not more than 30 calendar days after the recall.

A statutory recall notice is issued under s.46 of the Act. For a voluntary recall, the MAH, local responsible person, distributor or manufacturer must submit a draft notice with a factual statement of reasons and product identifiers to ZAMRA for approval before publication; the notice may not contain promotional material.

The Minister may by statutory instrument make regulations on the recall or withdrawal of medicines and allied substances that do not meet prescribed quality, efficacy and safety standards (s.69(2)(g)); separately, guidelines made by ZAMRA under s.68 become binding on all regulated persons upon publication in a daily newspaper of general circulation.

No person may sell a medicine or allied substance that is the subject of a s.46(1) recall notice; contravention is an offence punishable on conviction by a fine of up to one million penalty units, imprisonment of up to three years, or both.

Where ZAMRA determines it is not in the public interest that a medicine or allied substance be made available to the public, it may by written notice served on any person, or by Gazette notice, direct that person to return the product to the manufacturer, to the importer (for imported products) or to the Authority or its designee, and may direct the manufacturer or importer how to deal with or dispose of the returned stock.

ZAMRA triggers a statutory recall where a medicine or allied substance does not meet the set standard of quality, safety and efficacy; where continued supply violates the Act or another law; or where the Authority determines that continued availability is not in the public interest. Voluntary recalls (s.2.1) are triggered by the MAH/manufacturer on quality, complaint, stability or serious safety risk findings.

statement: Each of the device instruments gives the Authority a withdrawal power: where the Authority is of the opinion that the withdrawal of any batch of condoms (or gloves) is necessary for the protection of the public, it may require any person to withdraw such batch in accordance with the procedure it determines. Recalls of registered medicines are handled under MCAZ's separate product defects and recalls function, and the Strategic Plan assigns 'Monitoring product defects & recalls' to the Pharmacovigilance and Clinical Trials Division.