Manufacturer PMS by country

The opened legislation imposes no PMS plan, PSUR, PMCF/PMPF or trend reporting duty; instead, devices are subject during their life cycle to periodic controls by notified bodies to guarantee quality and functioning, per definitions in the order of the minister responsible for health.

The renewal dossier must include a summary of the materiovigilance system, the benefit/risk evaluation of the device in Algeria and in the country of origin, and the chronological detail of post homologation modifications submitted to ANPP (approved or under approval).

All holders of medical device registrations authorized by ANMAT must comply with the post market tecnovigilancia duties of Disposición ANMAT 8194/2023.

Registration holders must establish, elaborate, maintain and keep available to ANMAT trend reports (informes de tendencia) as part of post market surveillance.

Through a system for collecting and analysing data on the use and operation of the medical devices it has created, on their traceability and on the detection of side effects, the manufacturer carries out post registration surveillance of the safety and effectiveness of medical devices and submits reports on it to the authorised body in the procedure established by legislation.

Sponsors must provide annual reports for the first three years where a Class III, Class IIb implantable, or Class 4 IVD device is included in the ARTG (s 41FO(2) of the Act; reg 5.11 of the MD Regulations).

Records must be retained for 10 years for Class 4 IVDs, Class III and Class IIb implantable devices, or 5 years for other devices, after the last product has been distributed (s 41FO of the Act; regs 5.9, 5.10 and 8.1(b) of the MD Regulations).

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

NHRA Circular No. (18) of 2022 (12 May 2022), issued with reference to Article (4) of Resolution No. (48) of 2020, states that it is 'strictly recommended' that all healthcare facilities and authorized representatives assign a post market surveillance (PMS) officer responsible for handling medical device reporting in the post market phase, including field safety notices, adverse events and complaints, and reporting them to NHRA. For authorized representatives the assignment is made a general rule by the Medical Device Authorized Representative Registration Guideline (Version 7.4, June 2023), general rule 5: 'The Authorized Representative should assign a PMS Officer for handling all safety issues related to the medical devices (reporting FSN, Adverse events, Complaints...etc) as per Circular No (18), 2022.'

Once a Class B, C or D device is placed on the market in Bangladesh, the manufacturer or importer must adhere to post marketing surveillance requirements to systematically monitor the performance of the device during use in Bangladesh, with corrective and preventive actions under the QMS to prevent recurrence of adverse events.

Post market monitoring on the national route operates through the CM 177 incident system: RUP CEIZ collects and analyzes adverse event (incident) information from circulation subjects, users and monthly monitoring of foreign regulators' websites; the Ministry of Health supervises. Applicants must also notify the Ministry within one month of site address changes, loss of device status and voluntary recalls (CM 211 p. 22).

Reports under Articles 86 to 89 of Regulation (EU) 2017/745 (periodic safety update report, post market surveillance report, trend reporting) submitted to the Belgian authority are drafted in one of the three national languages or in English.

statement: AGEMED established a technical administrative reporting regime whose chapeau expressly covers 'medicamentos, vacunas, dispositivos médicos, reactivos de diagnóstico y equipos médicos'. Under it, every industrial laboratory, importer or national distributor must report referral prices by distribution channel five (5) working days before the start of commercialisation or a price change (literal a); a monthly stock report is established only for the medicines included in the current Lista Nacional de Medicamentos Esenciales, filed within five (5) working days after the end of the month (literal b); both reports are made exclusively through the 'AGEMED VIRTUAL' platform (literal c); any change to that platform is socialised by AGEMED by circular with a 30 working day implementation period (literal d); and every such virtual report and registration is a sworn declaration (Artículo Cuarto). · article: Artículo Primero (a) (d) and Artículo Cuarto

statement: The registration holder must notify AGEMED's Dirección de Medicamentos y Tecnología en Salud of the start of commercialisation of each registered device before commercialisation begins; when it decides not to continue commercialising the product it must inform that Directorate within no more than 20 working days so that the device's Registro Sanitario can be cancelled. The same Directorate must also receive, within a peremptory 15 working days and free of charge, a notification letter with supporting documentation for: the referral sale price of each product five days before the start of commercialisation or a price change; any change of regent or technical responsible (within 15 days); any partial or total, temporary or definitive closure of the company (5 days in advance); and any change of domicile, on form DINAMED Form. 003 (within 5 days of the change). · article: Numerales 3.1.6, 5.9 and 5.9.1 5.9.5

At state level, manufacturers and holders of an entry in the Register of medical devices of BiH are required to regularly update the data on the persons responsible for vigilance, as well as the data on other changes that may affect the vigilance system.

At state level, manufacturers and holders of an entry in the Register of medical devices of Bosnia and Herzegovina are required to keep a record of all adverse occurrences and safety corrective actions, including the adverse occurrences that do not meet the criteria for reporting. The same article requires them to determine, on becoming aware of an adverse occurrence connected with a device they market, whether it is an occurrence that must be reported — and to report it even where it is not established with certainty that it is harmful — to investigate occurrences and take the necessary corrective actions, and to deliver a final report at the end of the investigation.

At state level, misuse of a medical device that has not led to death, to serious deterioration of health or to a serious threat to public health need not be reported to the Agency. Such occurrences must be resolved within the manufacturer's own quality and risk management system, and the decision not to report must be justified and documented and, on request, made available to the Agency. The manufacturer is also required to report to the Agency a significant change of trend in misuse — an increase in frequency or a significant change in the cause of a problem that could potentially lead to death or serious deterioration of health — and to report misuse where it initiates a corrective action to prevent death or serious endangerment of health.

At state level the Agency may accept a periodic report or a trend report from the manufacturer after one or more reports have been assessed by the manufacturer and the Agency. The manufacturer and the Agency agree the form and the frequency of reporting for particular types of medical device and adverse occurrence. Periodic or trend reporting is acceptable where the manufacturer has issued a safety notice about an adverse occurrence and carried out safety corrective actions, or where the occurrences are common and well documented in agreement with the Agency.

At state level a trend report must be delivered to the Agency when there is a significant increase in the frequency of: (a) adverse occurrences that have already been reported; (b) adverse occurrences within Član 10 of the ordinance (the occurrences that need not be reported); and (c) occurrences that are not normally reported. Where an occurrence of a type previously judged to carry a negligible risk nevertheless results in death or significant deterioration of health, it must be reported and the risk reassessed, and those decisions must be documented; the Agency must be informed of changes in the trend of such events, most often an increase.

At state level the responsible person for medical device vigilance is the person who is responsible for establishing and operating the vigilance system at the manufacturer or at the manufacturer's representative, and that person must have a VIth level of professional qualification. The obligations of the manufacturer and of the holder of an entry in the Register of medical devices of BiH are set out in the same article.

The manufacturer must, prior to and after placing the product on the market, put in place a process as part of its quality management system to assess continued conformity of the device to the Essential Principles through the post marketing phase, covering complaint handling, post market vigilance reporting, and corrective and preventive actions. Submission of post marketing surveillance reports is also an express condition of the registration certificate.

The registration holder of a health product must structure and implement a technovigilance system in its company, providing the resources for its operation (RDC 67/2009 Art. 6º, items I XII: designated responsible staff, records of complaints and adverse events, evaluation, corrective and preventive actions).

The only post market duties on manufacturers in Brunei health product law are the standard provisions of the product licence in Rg 2 Schedule 1: to inform the Authority forthwith of information casting doubt on the safety, quality or efficacy data submitted (para. 3), to report adverse effect reports within 7 days (para. 4), to withhold or withdraw batches found harmful or non conforming if directed (para. 6) and to notify any withdrawal decision (para. 7), each expressed for 'any medicinal product to which the licence relates'. No manufacturer post market surveillance, periodic safety update or trend reporting duty exists for medical devices or IVDs.

The manufacturer must create and maintain a documented system for tracking the safety of the medical devices it has placed on the market.

Dealers of medical devices must maintain records of complaint reports and of the actions taken in response, produce those records for inspection by the Regulatory Authority when requested, and establish and implement documented procedures to conduct effective and timely investigations of reported problems. Complaint records must be retained for a period of five years on top of the device's projected useful life as determined by the product owner, and all persons placing devices on the market must be vigilant for changes in trends or frequency of adverse events.

The need for post market clinical follow up studies is determined from identification of residual risks that may affect the risk/benefit ratio, with circumstances including innovation in design, materials, principles of operation or technology, novel medical indications, a new approved indication or claim, changes to device design or labelling, changes in medical practice, higher risk classification and high risk anatomy. Such studies must have clearly stated objectives, a scientifically sound design with a rationale and statistical analysis plan, a study plan and implementation with analysis and conclusions. Their data and conclusions provide clinical evidence to support the post market surveillance programme, and may require the manufacturer to reassess whether the device still complies with the essential principles, leading to corrective or preventive actions.

Medical device licence holders must submit periodic summary reports containing a concise critical analysis of available scientific information on safety and effectiveness: Class II devices on a biennial basis, Class III and IV devices on an annual basis; changes in the benefit risk profile must be notified within 72 hours.

On receiving an adverse event notification, the legal manufacturer, importer or authorized representative must investigate and answer ISP using form ANDID/008 (including root cause analysis, risk evaluation, corrective/preventive actions and follow up); the deadline to submit the follow up and final report to ISP is a maximum of 6 months from the communication to ISP.

Registrants/holders must: establish and maintain a functioning QMS suited to the product; formulate and effectively implement post market research and risk control plans; conduct adverse event monitoring and re evaluation as required by law; and establish and operate product traceability and recall systems.

Holders must complete a periodic risk evaluation report (定期风险评价报告) for the previous year within 60 days after each anniversary of first approval/filing; NMPA registered products report to the national monitoring centre and provincially registered products to the provincial centre; Class I reports are retained by the holder.

Responsible professionals must register, analyze and manage every adverse event or incident possibly caused by a device, inform INVIMA immediately of serious events, and send quarterly consolidated periodic reports of all non serious event reports to INVIMA; the institutional program must include a data management system ensuring integrity/confidentiality and a Tecnovigilancia Manual analyzing reports by gravity, frequency and patient impact.

Manufacturers and importers must design and implement an institutional Tecnovigilancia Program ensuring permanent follow up of adverse events and incidents, designate at least one competent professional responsible for the program, communicate events to INVIMA, take immediate preventive/corrective actions, communicate international alerts associated with their devices, and cooperate promptly with INVIMA requests on device safety.

Manufacturers, importers and distributors must prepare and send periodic EMB safety reports to the CNTV: every 6 months during the first 2 years of marketing in the country; every year from the second to the fifth year; and every 5 years from the fifth year onward.

Manufacturers, importers and distributors must design and implement an Institutional or Company Tecnovigilance Unit to identify, record, evaluate and manage adverse event reports for the EMB they market, designate a trained health professional as the unit's responsible person before the CNTV, and communicate to the CNTV international alerts associated with devices they market and actions taken; the designated responsible person must be communicated to the CNTV and kept current.

The national regulatory authority is required to develop and operate a vigilance system throughout the whole life cycle of the medical device, 'life cycle' being defined as all phases of a device's life from its initial design through to its decommissioning and disposal. The manufacturer's post market obligations are: after investigation, immediately to inform and place at the disposal of the competent authorities every adverse event report concerning a device that it receives or holds, together with the safety corrective measures implemented; and to cooperate, at the competent authority's request, in implementing any measure adopted in order to reduce as far as possible the risks presented by a device placed on the market. The same cooperation duty applies to the manufacturer's representative, to importers/exporters and to distributors.

Manufacturers of Class I medical devices must prepare a post market surveillance report summarising the results and conclusions of the analyses of the post market surveillance data gathered under the post market surveillance plan, together with a rationale and description of any preventive and corrective actions taken. The report must be updated when necessary and made available to the competent authority on request. Croatian law penalises the failure of a Class I medical device manufacturer, or a Class A or B IVD manufacturer, to draw up the post market surveillance report and to provide it on request to the notified body and the competent authority, with a fine on the legal person in the range of 100.000,00 to 700.000,00 kuna.

During prórroga the manufacturer must demonstrate compliance with the same essential safety/efficacy requirements approved in the registration and additionally prove the effectiveness of the device in use during the approved validity period, taking into account the Cuban use phase. Inscribed suministradores must declare documented procedures for following devices in use in the SNS and for customer feedback, supplier evaluation and installation/maintenance support (E 129 25 acápites 4.2.4.2, 4.2.4.5, 4.2.4.6).

CYMDA requires manufacturers whose products are placed on the Cypriot market to play an active role in systematically and actively collecting information from the experience of use of their devices after they are placed on the market, in order to update their technical file and to cooperate with the competent authority.

SÚKL assesses manufacturers' trend reports under MDR Art. 88(1) / IVDR Art. 83(1); where the assessment indicates a risk to patients, users, other persons or public health, SÚKL calls on the manufacturer in writing to take suitable measures to protect public health and patient/user safety, and informs the Commission, the other competent authorities and the notified body that issued the certificate.

DKMA guidance for manufacturers requires trend reporting when the frequency of events increases relative to the accepted frequency in the risk analysis (trend reports go to the authority in the manufacturer's/AR's home country), and allows country specific agreements with DKMA for periodic reporting of well analysed recurring incidents — the duty to analyse all individual incidents remains, other involved states must be informed, and deviations require ordinary reporting.

statement: Sanitary authorisations for medicines and other sanitary products are temporary: the holder must notify its intention to keep the products on the market so the authorisation does not lapse, and renew it on compliance with the authority's requirements. Importers, manufacturers and health professionals are obliged to communicate adverse effects caused by medicines and other sanitary products when a danger to life or health may derive from them, or when the therapeutic effect proves invalid or does not produce the expected effects. At renewal, DIGEMAPS requires the applicant to file pharmacovigilance information covering every suspected serious adverse reaction of which it is aware, both in the country and abroad, and to state expressly and demonstrably where it considers there is no notable incidence. · article: Art. 116, primer párrafo y Párrafo I

Registration holders must: implement a Technovigilance Unit (UTV) with one or more health professionals related to device management and inform ARCSA of its creation/changes; report all reportable adverse events from patients, users, health facilities to the UZTV and/or CNTV; receive and channel to the manufacturer/product owner adverse event notifications; execute post marketing surveillance of the devices on behalf of the product owner; adopt corrective/preventive measures; and update the registration when technovigilance updates manuals/instructions.

Holders must keep a detailed physical or digital record/archive of all adverse event reports for at least five (5) years at the establishment, and must keep available the full technical documentation supporting the registration requirements for ARCSA inspection on demand. ARCSA performs risk based annual post registration control: Type 1 (visual verification of labels, insert, shelf life and storage vs approved registration) and Type 2 (representative sampling for quality control analysis at the ARCSA Reference Laboratory).

Manufacturers of Class I medical devices (and Class A or equivalent IVDs) must prepare a post market surveillance report summarizing post market data analyses with rationale and corrective/preventive actions, updated when necessary and available to the authority on request.

Class IIa, IIb and III devices (and IVD classes B, C, D) require a PSUR with a national appendix; Class IIb/III (IVD C/D) at least annually, Class IIa at least every two years, IVD Class B at least every 3 years, custom made devices annually or every 2 years per class; other devices provide PSURs on request. PSURs must cover benefit risk conclusions, PMCF/PMPF findings and sales/usage volume.

Manufacturers, scientific offices, authorized representatives, importers and distributors must appoint an authorized person (safety officer) to communicate with the Medical Devices Safety Unit (MDSU), and must document and implement written procedures for incident follow up, plus a tracking system recording supply and distribution information for complaints handling.

A trend report (Annex 10) must be made to MDSU on a significant increase in reportable incidents, expected side effects exempt from reporting, or normally non reportable events that could significantly impact the benefit risk analysis; methodology and observation period are defined in the PMS plan. EU Commission trend report forms may be used.

For each device, manufacturers must plan, establish, document, implement, maintain and update a post market surveillance system in a manner proportionate to the risk class and appropriate to the type of device; the system is an integral part of the manufacturer's quality management system under Article 10(9) of Regulation (EU) 2017/745.

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

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

class A and B: Post market surveillance report (Art. 80 IVDR): updated when necessary; available to competent authority on request · class C and D: Periodic safety update report (PSUR) updated at least annually; part of the technical documentation (Art. 81(1) IVDR)

class I: Post market surveillance report (Art. 85 MDR): summarises results and conclusions of PMS data analyses; updated when necessary; available to competent authority on request · class IIa: Periodic safety update report (PSUR) updated when necessary and at least every two years (Art. 86(1) MDR) · class IIb and III: PSUR updated at least annually (Art. 86(1) MDR); part of technical documentation

For each device, manufacturers must plan, establish, document, implement, maintain and update a post market surveillance system proportionate to risk class and appropriate to device type, integral to the QMS; the system is based on a post market surveillance plan per Annex III Section 1.1 which (for devices other than custom made) is part of the technical documentation (Art. 83, Art. 84 MDR).

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Trend reports and periodic summary reports (rapports de synthèse périodique) are declared to ANSM by email at materiovigilance@ansm.sante.fr; the manufacturer incident report format MIR 7.3.1 (PDF) applies since 1 May 2026, and the Vigimater application lets each declarant follow report progress.

Under the Code of Georgia on Product Safety and Free Movement a manufacturer must, within the scope of its competence, warn end users of any visible or invisible risks contained in a product when used as intended and within a predefined period of time, as well as of risks that may not be immediately apparent, and must provide for measures with respect to products that will enable it to analyse the risks the product may cause and to take appropriate measures to prevent risks, including warning end users and recalling products from end users and the market. It must provide a distributor with complete information about product related risks so that the distributor can pass that information to a third party, and must within the scope of its activity contribute to ensuring the safety of products placed on the market. The manufacturer's post market duty is therefore a continuing risk analysis and preventive action obligation that runs for as long as the product is on the market, and recall from end users and the market is one of the measures it must have provided for.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

The manufacturer is required to demonstrate a system for post market surveillance as part of the regulatory framework, alongside the QMS, technical documentation and declaration of conformity.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Chapter III of Normativa 19 2009 imposes obligations on 'la empresa autorizada para la comercialización de medicamentos': keep a detailed register of suspected adverse reactions, report serious suspected reactions to the National Coordinating Centre immediately and in any case within fifteen calendar days, submit periodic safety reports, run pharmacovigilance and risk management plans, and (Art. 10) keep a permanently available qualified professional responsible for pharmacovigilance. Devices appear only in Art. 2.2, where 'ensayo clínico' includes experimental evaluation of a 'dispositivo'. The norm therefore does not itself create a manufacturer post market surveillance duty for medical devices.

The Boleta de Notificación de Tecnovigilancia F FV c 04 version 03 2025 is the official form for reporting adverse events or quality failures of medical devices. It is sent to farmacovigilanciadrcpfa@mspas.gob.gt or presented at the window of the Dirección de Regulación, Vigilancia y Control de la Salud, Avenida Bolívar 28 07 zona 8, Guatemala; the form states that notification lets the Programme collect information on the effectiveness of medical devices used in medical and surgical settings, and asks for any relevant attachments such as photographs, contracts or letters.

Section 3 of form F FV c 04 requires the device's generic name, lot number, brand, model, sanitary inscription number (marked in the instructions as indispensable), place of purchase and expiry date; section 4 requires a description of the adverse event or quality failure, the notification type (evento adverso, falla de calidad, otro), the body area and the outcome (recovered with sequelae, required medical or surgical intervention, life threatening, malformation, no harm, unknown, death with date).

For device categories listed in GN 01 Appendix 1, the LRP must submit surveillance reports (local, overseas or both) to MDD at least once a year; MDD may revise the schedule.

Applications may be approved, conditionally approved or rejected; conditional approval can impose conditions such as annual submission of post market surveillance reports, and non compliance with a condition may result in delisting.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

The manufacturer of a device other than an investigational device must establish, document, implement, maintain and update a quality management system under Article 10 of the Regulations and a risk management system as described in the Regulations. It must operate a post market surveillance system and draw up a plan in accordance with Chapter VII of the Regulations, and must produce post market surveillance reports under Chapter VII. The reports must be updated as necessary and supplied to Lyfjastofnun at the agency's request.

Holders of Form MD 27 no predicate permission must submit Periodic Safety Update Reports to the CLA from the date of market launch: every six months for the first two years, then annually for two further years, and must inform the CLA of the launch date; Fifth Schedule 8.5.1 additionally requires documented advisory notice procedures, complaint investigation records and adverse event notification to the authority.

The izin edar holder of devices and PKRT must perform sampling and testing at least once during the validity period of the authorization; testing of samples is carried out by accredited laboratories, and sampling/testing activities are reported through the health information system integrated with the national health information system.

The izin edar holder must report potential shortages of health supplies to the Minister at the latest 6 months before the shortage occurs; the Ministry responds through accelerated izin edar and the special route mechanism.

License renewal requires post market evidence: production statistics (آمار تولید), complaint and quality problem documentation and resolution (مدارک و مستندات رفع شکایات و مشکلات کیفی), discharge of prior commitments, valid mandatory standard license for covered products, and closure of non conformities observed in surveillance assessments (ارزیابی‌های مراقبتی).

The MOH Medical Devices Management Department's follow up duties include maintaining a detailed statistical database on the numbers of medical devices in MOH facilities and working to test and evaluate device performance and their need for calibration and periodic maintenance; it also follows up devices with the health directorates regarding installation, warranty and maintenance.

Under the MOP standard contract, supplier obligations include installation, demonstration and on site training at end user sites (priced in the schedule), keeping sufficient stock of required spare parts, and an annual 'UPTIME' warranty percentage (e.g. 95% or 98%) with annual maintenance contract extension as the remedy during the AMC period.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

For Class I medical devices a Post Market Surveillance Report (PMSR) is required, detailing the monitoring and audit activities performed to improve the device's safety and quality and to correct deficiencies found. The ministry's supervision page further requires monitoring and audit activities to evaluate registered devices and improve their safety and quality, with reporting to AMAR.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

MAH postmarketing safety management (製造販売後安全管理) must comply with MHLW Ordinance No. 135 of 2004 (GVP), the standards designated under Arts. 12 2(1)(ii), 23 2 2(1)(ii) and 23 21(1)(ii) of the PMD Act.

For MHLW designated devices/IVDs, the approval holder must apply within 3 months after the end of the MHLW directed survey period for the use results evaluation (使用成績評価) — the re examination of the approval.

The device manufacturer or its authorized representative must report to the state body and the expert organization an Incident Report and a Corrective Action Report for adverse events (incidents); holders/manufacturers must fully submit safety information to the authorized body.

Marketing authorization holders must monitor the safety of their products on the market and comply with pharmacovigilance; the manufacturer must establish, document and maintain throughout the device life cycle an ongoing risk management process per ISO 14971 and a Quality Management System aligned with ISO 13485:2016, with risk management linked post market to production/process controls, CAPA, servicing and customer feedback.

PPB requires marketing authorization holders to nominate a Qualified Person for Pharmacovigilance (QPPV) a 'Final Notice on Nomination of QPPV' was issued to MAHs and local technical representatives, and PPB maintains 'Guidelines for Establishment of the Qualified Persons for Pharmacovigilance'.

statement: For each device, manufacturers must plan, establish, document, implement, maintain and update a post market surveillance system proportionate to the risk class and appropriate for the device type. That system must be an integral part of the manufacturer's quality management system referred to in Article 10(9), and must actively and systematically gather, record and analyse data on quality, performance and safety throughout the device's lifetime. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: postmarket surveillance · localApplicationRequired: No · targetDecisionRetained: No

The Ministry of Health has the right to block the authorisation it has granted to a supplier and even to cancel it where the supplier does not honour its obligations in the post commercialisation phase.

Together with the registration documents for every product it intends to place on the Lebanese market, the manufacturer or its commercial representative must communicate any information or measure taken to accommodate environmental or use conditions specific to the local market, and must specify the measures to be taken to ensure that medical devices are stored, transported, installed and maintained and that users are trained in their use.

Hospitals must retain records and all documents created within the quality management system for serious incident reporting for at least 15 years (EWR MepV Art. 16(4); EWR IvDV Art. 16(4) mirrors this for IVDs). Other PMS/PMCF duties are EU level under MDR/IVDR.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Registration holders and filers must proactively conduct post market evaluation where scientific or technological change alters the understanding of the device's safety or effectiveness, or where adverse event monitoring indicates a possible safety defect.

Every establishment must monitor the safety and performance of devices it manufactures, imports, exports or places on the market, operate a post market surveillance system as prescribed by the Minister, and properly record and evaluate adverse incident surveillance reports; it must also maintain documented complaint handling procedures and records. The Medical Device (Duties and Obligations of Establishments) Regulations 2019 detail these duties (distribution records, complaint records, mandatory problem reporting, field corrective action, voluntary and mandatory recall), fully enforced from 1 July 2022.

For each device, the manufacturer must plan, establish, document, implement, maintain and update a post market surveillance system proportionate to the risk class and appropriate to the device type, as an integral part of the quality management system required by MDR Article 10(9). The system must actively and systematically gather, record and analyse data on quality, performance and safety throughout the device's lifetime and determine, implement and monitor preventive and corrective actions. On the Maltese side, every economic operator must keep a register of complaints, of non conforming devices and of recalls and withdrawals and keep the competent authority informed of that monitoring; the Authority's directorate states that it oversees post market activities and addresses incident reports.

Under the mandatory device GMP norm, manufacturers must maintain documented methods to ensure traceability of design and development inputs and outputs, and production records traceable to operators and supervisors; NOM 241 SSA1 2025 covers manufacturing and warehouse establishments.

The authorised representative must satisfy itself that the manufacturer makes available to it the information necessary to exercise its legal duties. That information must include, without being limited to: declarations of conformity; copies of labels; copies of packaging; instructions for use; conformity certificates where applicable; a description of the post market surveillance processes; the data resulting from post market surveillance; a description of the vigilance processes; the data and reports from the vigilance system, including complaints; the technical documentation; clinical data and notifications; details of any distributor on the market of the Republic of Moldova; incident reports; and corrective actions. The manufacturer must guarantee that it will inform the authorised representative of incident reports and field corrective actions, and where an incident with a device occurs the authorised representative must inform the manufacturer and provide advice on its implications.

The manufacturer and the supplying organisation must conduct surveillance studies (тандалт судалгаа) on the medical devices they supply and, where necessary, must bear the costs of testing medical consumables, of inspection, verification and calibration of medical equipment, and of analysis of laboratory diagnostic devices; where the requirements are not met they are obliged to recall the product. Market surveillance and a user study are also carried out before renewal of an IVD registration, and the renewal dossier includes a post market surveillance report.

statement: The manufacturer, or the authorised representative, must continuously monitor the medical device on the market in order to identify the need to apply immediately all necessary corrective or preventive measures, keep records of the corrective and preventive measures implemented, and inform the Institute of them. · pmsOwner: manufacturer or authorised representative

For the renewal of a registration certificate the technical part of the file must contain, for all risk classes and all devices, a materiovigilance review of the last five years issued by the manufacturing establishment, together with the draft label and, where applicable, the draft instructions for use. The manufacturer must therefore maintain a five yearly post market vigilance record for each registered device.

Article 11 of loi 84 12 obliges manufacturing, importing, exporting and distribution establishments and their delegatees to comply with the rules of good practice for manufacture, transport, storage, distribution and 'évaluation de la performance' of medical devices fixed by regulation; arrêté 2856 15 article 3 fixes those rules as the Moroccan standard NM ISO 13485 in force. A subcontracting delegatee must give an undertaking to comply with the same good practices (arrêté 2854 15 art. 1).

Article 16 of loi 84 12 makes the registration holder responsible for the ongoing (permanent) evaluation of the clinical data of its products in line with the evolution of scientific data, with a duty to report in writing to the administration any modification affecting those data or the content of the registration dossier of a device placed on the market.

DFDA Medical Device Section post market control comprises market sample collection, laboratory testing of market samples, handling of medical device adverse event reporting, field safety corrective action, and awareness programs to consumers and healthcare professionals.

Until all EUDAMED modules are functional, manufacturers send their reports on serious incidents, FSCA with field safety notice (FSN), periodic summary reports (PSUR) and trend reports to the IGJ via the secured email channel stated on the IGJ contact page.

The sponsor must put in place any procedures necessary to ensure compliance with the notification, information and update regulations (regs 5, 6 and 8). Medsafe additionally expects every sponsor to hold a written recall procedure describing how a recall action will be initiated, and to report progress and final closure of recall actions.

A post market surveillance plan must be developed in accordance with the NAFDAC Guidelines for Detecting and Reporting Adverse Reactions for Pharmaceutical Products and Medical Devices including IVDs.

NAFDAC publishes a dedicated 'Guidelines for Post Market Performance Follow up (PMPF) for Medical Devices including IVDs' (guidance document, PV category) in its official guidelines catalog.

Manufacturers must operate a trending system monitoring frequency/severity of incidents, conducted periodically (e.g. monthly), and summarize all feedback into periodic reports to the Director PMS as required by the Medical Device Regulation.

The holder of an authorisation to place a medical device on the market must organise a materiovigilance system for its devices, run by an employed person responsible for materiovigilance who has a health field qualification. The materiovigilance system covers the collection, processing and assessment of periodic safety reports for medical devices received from the marketing authorisation holder and the data from post market non interventional studies.

The holder of the authorisation to place a medical device on the market submits periodic safety reports for its devices, referenced to a Data lock point (DLP) defined in the rulebook, and the materiovigilance system processes and assesses those reports together with the data from post marketing non interventional studies received from the holder.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Medical device manufacturers must prepare a periodic safety update report (PSUR) for each device (and where relevant per category/group) summarizing post market surveillance results with preventive/corrective actions; throughout the device lifetime it must set out benefit risk conclusions, PMCF main findings, sales volume and user population estimates; Class C&D manufacturers update the PSUR at least annually.

Under rule 49(1), for post marketing surveillance and vigilance of marketed medical devices, a licensee must establish, maintain and implement an appropriate and effective post marketing surveillance and vigilance system for the devices he is dealing with, including the elements listed in the rule.

DNDM must design and implement a device vigilance system to prevent, detect and correct irregularities affecting safety/efficacy (norms and guides, training, failure categorization, intervention, sanctions, standardization). Manufacturers, suppliers and all medical, scientific and technical personnel of the public and private sectors are obliged to notify the health authority of suspected adverse events or incidents, failures and alerts derived from or during the use of products marketed in Panama.

Registration holders must implement and maintain a documented system for collecting and managing reports of adverse events and incidents and safety information generated by their devices, and must communicate the alerts and measures taken abroad concerning their products.

Periodic safety reports are submitted: every six months during the first two years from authorization; annually for the following three years; and every five years from the sixth year onward. Device reports follow Art. 156 content; NTS 123 numeral 6.7(g) makes holders responsible for producing them under current norms.

The establishment's qualified person must ensure observance of good storage and distribution practices, monitor inventory including expiry, ensure any adverse event is properly handled, documented and reported through the supplier/distributor chain, ensure all products sold carry FDA authorization, and keep updated on AO 2018 0002 implementation.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

IMD registration requires a post marketing surveillance plan for local implementation as a checklist document.

Sponsors must notify ANMDMR of PMCF study plans (MDR) and PMPF plans (IVDR); ANMDMR evaluates the notification documentation for a fee of 1,880 lei.

Post registration clinical monitoring is conducted under a Post Registration Clinical Monitoring Plan submitted as part of the state registration dossier; the registration guidance likewise requires a clinical monitoring plan (план клинического мониторинга) in the dossier for class 3 and implantable class 2б devices.

For class 3 devices and implantable class 2б devices, the registration certificate holder must conduct post registration monitoring of safety and clinical effectiveness and submit annual clinical monitoring reports to Roszdravnadzor for 3 years, no later than 1 February, starting from the year following the year of RU issuance.

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

Non IVD devices: class A manufacturers prepare a post market surveillance report (updated as necessary, available to SFDA on request); class B, C and D manufacturers prepare a periodic safety update report (PSUR). IVDs: class A and B manufacturers prepare a post market surveillance report; class C and D manufacturers prepare a PSUR.

Décret n° 2023 2419 places continuing post market obligations directly on the medical device manufacturer. The seventh indent of art. 34 requires the manufacturer to 'informer immédiatement et mettre à la disposition de la structure en charge de la Réglementation pharmaceutique, tout rapport d'événement indésirable d'un dispositif médical qu'il reçoit ou qu'il possède après investigation, ainsi que les mesures correctives de sécurité mises en œuvre' (immediately inform, and make available to, the pharmaceutical regulation structure any adverse event report concerning a medical device that it receives or holds after investigation, together with the safety corrective measures implemented). The eighth indent requires it to 'contribuer, à la demande de la structure en charge de la Réglementation pharmaceutique, à la mise en œuvre de toute mesure adoptée en vue de réduire autant que possible les risques présentés par le dispositif médical mis sur le marché' (contribute, at the request of the regulation structure, to the implementation of any measure adopted to reduce as far as possible the risks presented by the device placed on the market). The same two duties are imposed on distributors and manufacturer representatives by the second and fifth indents of art. 35, and the ninth indent of art. 34 keeps the manufacturer the sole principal ('demeurer le seul donneur d'ordre, responsable de son produit même en cas de contractualisation avec un représentant ou un sous traitant'). The fourth indent of art. 34 requires the technical documentation and declaration of conformity to be kept for the product's life cycle. Art. 43 makes after sales service ('le service après vente'), quality control, promotion and advertising control, the fight against substandard and falsified devices, inspection of supply chain actors and matériovigilance components of the device post marketing surveillance system.

The manufacturer must establish and maintain a post market surveillance plan involving collection, analysis and investigation of every complaint, quality defect and incident reported by users, and keep records of non compliant and withdrawn devices (custom made and clinical investigation devices excepted). The manufacturer/AR must continuously monitor the device on the market, keep a record of implemented corrective and preventive measures and report them to ALIMS; ALIMS may require a reasoned, evidence based report on market experience.

Class I (except Ir, Is, Im) and other IVD/class A manufacturers compile a post market surveillance report (summary of results, conclusions and preventive/corrective measures), updated as needed and submitted to ALIMS on request. Manufacturers of Class IIa, IIb and III devices, active implantable devices, IVDs and self testing devices compile a Periodic Safety Update Report (PSUR) per device/category: Class IIb/III, active implantables, IVDs and self testing devices update it at least annually; Class IIa as needed and at least every two years. For Class III, implantable and IVD List A/class D devices the PSUR is submitted to the conformity assessment body, which appends its assessment and makes it available to ALIMS.

Manufacturers, importers, wholesalers, registrants and persons supplying unregistered devices under the regulations must maintain a record of every complaint received pertaining to the device (name, date, complainant, control/lot/batch/serial number, nature of the problem) and retain records for at least 5 years after the expiry of the projected useful life; offences up to $10,000/6 months ($20,000/12 months for false records).

Every licensee and registrant must inform the Authority within 15 days of receiving any information which adversely affects the validity of data furnished to the Authority relating to the quality, safety or efficacy of the device; offences up to $10,000/6 months.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Until EUDAMED functions, RS seated manufacturers and authorised representatives must submit periodically updated safety reports for class III devices and implantable devices to the notified body involved in the conformity assessment; the reports and the notified body's evaluations are available on request to JAZMP and the competent authorities of EU member states.

The authorised representative or holder of a certificate of registration must, within Council determined time frames, inform the Council of steps taken to address adverse events; on Council request conduct a concise critical analysis of safety and performance and submit the results within a specified time frame; where safety concerns are confirmed, submit case reports, usage figures, periodic safety update reports and performance studies; and keep and maintain (or have access to) records of adverse event data for their devices.

Re examination target manufacturers/importers report survey results annually, within 2 months after each 1 year period from the marketing date; after result notification, follow up measures must be taken within 30 days.

At product approval MFDS sets the post market survey (시판 후 조사) period, generally 3 months; the re examination (재심사) period runs within 4 to 7 years after approval and may be extended within that range through the Medical Device Committee.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

The applicant (manufacturer or importer) must confirm responsibility for the safety, quality and effectiveness of the registered device, keep information up to date, maintain a proper system to handle side effects or problems with the product, perform quality control checks and use suitable packaging; MAHs must also handle quality failures for foreign manufacturers.

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Manufacturers of Class IIa, IIb and III devices must prepare a safety update report (Sicherheitsbericht, PSUR) for each product or product category/group: Class IIa updated as needed and at least every two years; Classes IIb and III at least once a year. For Class III and implantable devices the report and its amendments are reviewed by the designated body, and on request must be submitted to Swissmedic.

For every product, manufacturers must plan, establish, document, apply, maintain and keep up to date a post market surveillance system proportionate to the risk class and the type of product; the system is an integral part of the manufacturer's quality management system, and its modalities (including updates of the technical documentation) follow Art. 83(3) EU MDR.

The safety monitoring period runs three years from the licence issuance, filing, announcement or designation date (extendable where necessary). Periodic reports are due semi annually: the data collected in each period must be entered within 30 days after the period ends; a summary report must be entered within 60 days after the monitoring period expires. The second type of monitoring plan requires prior central authority approval. Monitoring data must be kept five years after the monitoring period ends.

For devices approved or filed, the central authority may order the device firm to conduct safety monitoring under an approved monitoring plan; firms must prepare periodic safety monitoring reports and submit them to the central authority. Non submission or inadequate execution may lead to ordered improvement, suspension of manufacture/import/sale, and for serious cases revocation of the licence or filing. Monitoring covers collection of domestic and international user numbers and adverse event data, or planned periodic follow up of specific users for specific safety issues.

Manufacturers must maintain written procedures for serious adverse event reporting under Act Art. 48(1), Act Art. 49 notifications, corrective and preventive measures, and Act Art. 58 recall notices with deadline bound recall handling. The reporting, corrective action and recall handling must be recorded and kept.

Submission of biannual post marketing surveillance reports is a standing condition for validity of registration.

The applicant must conduct market surveillance activities once the product has been granted marketing authorization, and provide technical support and services to users of the registered device.

Four categories of operators (including manufacturers and importers of medical devices) must submit annual reports for the preceding year by 31 March of the following year.

Manufacturers of class IIb and class III devices update the periodic safety update report at least once per year; class IIa manufacturers update it where needed and at least once every 2 years; the PSUR forms part of the technical documentation.

The post market surveillance system is an integral part of the manufacturer's quality management system referred to in Article 10(9).

S.I. 2014 No. 29 reg. 40(5) places a continuing market obligation on the holder of a certificate of registration: the holder 'shall monitor the safety and effectiveness of the registered ... surgical instrument while on the market in Uganda and shall submit periodic reports as may be prescribed by the Authority'. Reg. 42(2) makes that obligation concrete at renewal, requiring the renewal application to be accompanied by a consolidated report of the changes made with respect to the registered product during the validity of its registration — whether or not those changes were reported to the Authority — and a report of additional adverse drug reactions detected during the lifetime of the registered product. DAR/GDL/028 s. 4.7 conditions the continuing validity of registration on submission of annual post marketing surveillance reports for those products NDA defines to be of high risk or to require special attention, and on submission of adverse effect reports for products classified as class D. DAR/GDL/028 s. 4.14 expresses maintenance of registration status as subject to consistent quality and satisfactory performance of the product on the market and to payment of the annual retention fee.

In the application for design/system examination the manufacturer undertakes to systematically analyse experience gained from post market use of its devices and to ensure corrective measures where devices no longer comply.

The Marketing Rights holder (or its representative) must monitor the performance of the marketed product, receive effectiveness/safety/quality reports from health establishments, comply with EDE pharmacovigilance guides, and follow up product withdrawal procedures.

EDE approved a Pharmacovigilance Practice guideline for medical products by Resolution of the Chairman of the Board No. (27) of 2026, published 27 July 2026.

Manufacturers must produce a periodic safety update report (PSUR): the first within 1 year of placing on the market or putting into service (whichever is sooner) and updates at least every year until the end of the PMS period (every 2 years for class IIa); PSURs must be submitted to the approved body for the device, which for Class III/implantable devices must issue a report to the manufacturer and UK responsible person, and completed reports must be provided to the Secretary of State on request within 3 working days. Manufacturers must also trend report significant increases in the frequency or severity of incidents (and, for IVDs, significant increases in expected erroneous results), judged against the statistical methodology in the post market surveillance plan.

Manufacturers of Class I devices (under Directive 93/42, Regulation (EU) 2017/745 or the domestic classification) and IVD class A/B devices not on the Annex II list must produce a post market surveillance report including a summary of results and conclusions of analyses of collected information and a description of preventive/corrective actions; it must be produced within 3 years of the device being placed on the market or put into service (whichever is sooner) and updated at least every 3 years until the end of the PMS period.

The holder of an approved PMA must comply with 21 CFR part 803 (MDR) and, unless FDA specifies otherwise, submit periodic reports that identify changes described in 21 CFR 814.39(a), include a summary and bibliography of new safety and effectiveness information, document changes made under exceptions (21 CFR 801.128, 809.11), and identify device identifiers in use and discontinued (21 CFR 814.84).

The Director Técnico and the legal representative are responsible for communicating to the DTM MSP any problem that arises during commercialisation of the products, and remain responsible for the product during the whole habilitación period and while products remain on the market.

The registration dossier must include a list of adverse events and withdrawal report and a plan for collecting and analyzing post market data on the device's safety and efficacy. Devices extended without laboratory testing (no quality related changes) undergo mandatory post market control; quality control after expiry follows the documents approved during the certificate's validity.

A statutory reporting template exists for export, import, inventory and use of devices (and manufacturing materials/external check substances containing narcotics or precursors), directed to health authorities.

statement: Applicants must disclose their post market record as part of the dossier: the Annex I form asks whether there have been previous recalls, reportable adverse incidents, banning in other countries or post market surveillance studies, requires details of each item ticked, and requires any relevant documentation to be attached, and the Chapter 2 Submission Context block requires global market history including global incident reports and recalls and sales, incident and recall rates. Once authorised, the marketing authorisation holder must put in place a vigilance system to monitor the quality, safety and performance of the device on the Zambian market and ensure that modalities to provide routine reports to the Authority on any findings regarding the product are in place (non IVD guideline s.1(p)); the holder must also pay the annual retention fee by 31 December each year, failing which importation is not authorised and the authorisation is suspended and may be revoked (s.1(o)), and is the addressee of suspension or revocation notices.