🇹🇼 Taiwan medical device regulatory data

Before publishing medical device advertising, the licence holder or filer must apply to the municipal or central authority with the advertising content for approval; after approval the holder must present the approval document to media operators before broadcasting, and the approved content may not be changed during the approved period. The approval document is valid for three years from issuance; extension is applied for within six months before expiry, each extension not exceeding three years.

Devices whose IFU states they must be used by healthcare professionals (and announced devices) may only be advertised in media aimed exclusively at healthcare professionals or at professional academic events. Advertising may not borrow others' names, guarantee efficacy or performance using publications/documents/materials, use interviews or news reports as promotion, or use other improper methods. Non-devices may not bear or advertise medical efficacy claims (unless other laws provide otherwise).

Class I filers whose filing has been complete for one year must perform an annual declaration (年度申報) each October in the filing system, confirming the filed particulars and paying the annual fee, to maintain the filing.

The manufacture/import licence is valid for a maximum of five years from the issuance date. To continue, an extension must be approved before expiry; each extension may not exceed five years.

If the extension is not applied for before expiry, a fresh registration under Articles 5 and 6 of the licence regulation is required and a new licence number is issued on approval; for Class II/III devices re-applied within six months after expiry a simplified document set (business permit, original licence, approved labels, free-sale certificate, QMS evidence etc.) is accepted.

Extension applications must be submitted within six months before the licence expiry date, with the prescribed documents and fee (official processing limit: 60 calendar days, or 180 days where safety-monitoring or post-market study reports must accompany the extension).

The distribution permit is valid for three years. Extension is applied for between 12 and 6 months before expiry, each extension capped at three years, following the same application/inspection procedure. Name or address changes must be filed within 30 days of the change (original expiry not extended); changes to operations or storage sites go through the full inspection procedure again. Where a timely extension is undecided at expiry for reasons not attributable to the distributor, the permit stays effective until the decision date.

The central authority may commission legal entities or associations to run technical personnel training and to conduct device firm inspections covering Act Art. 22 QMS matters and Act Art. 24 GDP matters. Training bodies must be established at least three years and pass the TTQS quality assessment; inspection bodies need at least three full-time inspectors with documented procedures. Accreditation lasts three years (extension applied 12 to 6 months before expiry, capped at three years) and an administrative contract must be signed within one year. Inspectors must recuse themselves from cases involving devices they designed, manufactured, supplied or serviced (or within five years of such roles), records are kept at least six years, and sub-delegation of inspection work is prohibited.

Ministry of Health and Welfare (MOHW) is the competent authority at the central level for medical devices; municipal and county/city governments are the local competent authorities. The Ministry's Food and Drug Administration (TFDA) administers the regime in practice (all subordinate regulations were issued by TFDA).

Changes to items designated by the central authority require prior approval (Act Art. 26). The licence regulation lists ten approval-required change items: Chinese product name; English product name; original label, IFU or packaging; composition, materials, structure, specification or model; efficacy, use or indication; manufacturer name; manufacturer address or country of manufacture; licence owner (transfer); licence owner name; and manufacturing permit number. Replacing lost/damaged licences or approved label documents also requires application.

Minor label/packaging changes need no prior approval: (a) changes that do not alter the approved text (materials/graphics, proportional resizing, font changes, adding printed outer boxes), and (b) enumerated text changes such as adding or changing barcodes, recycling marks, CE marks, suggested retail prices, or distributor name/address; the holder makes the change and keeps a change record.

Sponsors must define, execute and manage the clinical trial and ensure data integrity and subject rights, safety and welfare (GCP Regulations Art. 5; investigator-initiated trials are subject to the same sponsor rules, Art. 24). For multicentre trials the sponsor must appoint a lead principal investigator and allocate responsibilities in writing (Art. 12).

Sponsors or trial institutions must obtain central-authority approval before starting a medical device clinical trial; announced non-significant-risk device trials are exempt from prior approval. The trial plan must also be approved by the institutional review board: the sponsor prepares the clinical trial plan, which may only be executed after approval by the review committee (審查會) and the central authority.

During clinical trials, where a device defect could cause a serious adverse reaction, the sponsor must notify the central authority within 7 days of learning the facts and submit detailed investigation data within 15 days; investigators must immediately notify the trial institution, sponsor and review committee with a written report. For trial-subject serious adverse events (death, life-threatening, disability, congenital malformation, hospitalisation), reports are due within 7 days with detailed data within 15 days (Act Art. 38).

Medical device means instruments, apparatus, appliances, materials, software, in-vitro diagnostic reagents and related articles whose design and use act on the human body by means other than pharmacological, immunological, metabolic or chemical action, to achieve one of: diagnosing, treating, mitigating or directly preventing human disease; regulating or improving body structure or function; or regulating fertility.

Software (軟體) and in-vitro diagnostic reagents (體外診斷試劑) are explicitly named within the statutory definition of medical device, so SaMD and IVDs fall under the same regime (no separate IVD statute).

Class I registration applications must include the documents and data of Annex 1 (documents for Class I device registration for manufacture or import); the central authority may decline to register the specification/model and label/IFU/packaging items (Art. 5 para. 2).

Class II and III registration applications must include the documents and data of Annexes 2 and 3, which include (per the regulation's definitions and extension article) the country-of-origin free-sale certificate, foreign manufacturer letter of authorization, QMS conformity evidence, and for Class II a product-comparison and pre-clinical test data conformity declaration (產品比較暨臨床前測試資料符合性聲明書, Annex 3).

Licence extension applications require the application form, original licence, country-of-origin free-sale certificate, foreign manufacturer letter of authorization, QMS evidence and the fee, submitted within the statutory window before expiry.

Application documents must be in Traditional Chinese or English; documents in other languages must be accompanied by a Traditional Chinese or English translation.

Contract manufacturing means entrusting the full process (manufacture, packaging, labelling, sterilisation and final release) or the manufacturing/sterilisation steps to another device manufacturer. It requires prior approval from the central authority with the parties' business licences, the contractor's manufacturing permit (excused for items exempt under Act Art. 22(2)) and a written contract stating names, agreement, classified device items, processes and the parties' rights and obligations; the approval is registered, changes are filed within 30 days. Labels, IFUs and packaging of fully contracted products must carry both parties' names and addresses (the contractor's may be replaced by country/region where already recorded in the registration system). Product violations are the responsibility of the commissioning party.

Where a distributor outsources import, storage, transport, sale, protection or servicing to another party, the arrangement must be covered by a written contract and monitored wherever it can affect GDP conformity; the related distribution records are subject to the same retention duty. The distributor must take measures ensuring the contractor complies with the contract, the GDP Regulations and other law.

Foreign-manufactured devices are placed on the market through a locally registered medical device firm acting as importing agent and licence/filing holder: QMS inspection and manufacturing-permit applications for imported devices must be filed by the importing medical device firm (代理輸入之醫療器材商), which is recorded on the manufacturing permit; imports must be made by the licence owner, filer or their authorised party; medical device firms must be approved and registered locally before operating.

A change of licence owner (許可證所有人, transfer/移轉) is an itemised change requiring prior approval from the central authority with the documents of Annex 4 and the change fee; the official processing time limit for transfer cases is 60 calendar days.

Where a manufacturer entrusts manufacture, processing or services to another party (受託者) for processes that can affect product conformity, a written contract must be concluded and the arrangement monitored. The manufacturer must take measures ensuring the contractor's processes comply with the contract, the QMS Regulations and other applicable law.

To operate as a medical device firm (manufacturer or distributor, including importers), the company must be approved and registered with the municipal or county/city government health authority and hold a business permit (許可執照) before commencing business.

Distributors of announced device categories must establish a good distribution practice (優良運銷) system per the GDP Regulations and pass central-authority inspection to obtain a distribution permit (運銷許可) before wholesaling, importing or exporting; distributors must establish and maintain the GDP system in writing (Art. 3 GDP Regulations), covering storage, transport and temperature control for temperature-sensitive devices.

Manufacturer premises must have smooth, crack-free, easily cleaned ceilings, walls and floors; adequate lighting and ventilation with temperature/humidity/cleanliness controls where needed; protection, first-aid and isolation facilities for flammable or hazardous materials; warehouses for raw materials, intermediates and finished products; and changing rooms and hand-washing facilities with sterilisation equipment for work clothing as needed. Buildings must be structurally safe with rodent-, insect- and dust-proof design; work areas must be clearly separated, with dedicated or effectively segregated areas when other products are co-manufactured; environmental controls (and cleanrooms per ISO 14644 where air cleanliness matters) are required.

Device firms must employ at least one technical person per applicable category: manufacture of IVDs and of non-IVDs for manufacturers; import and IVD/non-IVD repair technicians for import or repair distributors. Manufacturing technicians need a relevant degree (medical engineering, medical laboratory science, or science/engineering/medicine/agriculture) plus 1-3 years of manufacturing experience; radioactive-device technicians may alternatively hold medical-radiology degrees with one year of experience. Import technicians need a degree, one year of manufacturing or registration-filing experience, and at least 20 hours of training within the past five years covering device law, QMS, dossier preparation and filing practice, and post-market management.

Manufacturing technicians are responsible for resident supervision of manufacturing, QMS documentation, adverse event management, safety monitoring matters and Act Art. 29 technical documentation; import technicians manage the same registration/monitoring duties plus source-and-flow documentation; repair technicians must verify repaired product safety and performance and sign repair records, which the repair distributor keeps for at least five years. Every technical person must complete eight hours of continuing education each year (law, quality management, violation case analysis); failure leads to ordered correction and ultimately a mandatory personnel re-registration, with penalties under Act Art. 70(1)(1).

Distributors seeking a distribution permit (運銷許可) file an application (Chinese or English, with translations for other languages) with the central authority, attaching the business licence copy, documentation index, quality manual or equivalent, a floor plan of the premises marking storage, inbound/outbound and other work areas with flow lines, and a distribution process flow diagram including outsourced operations; a fee applies. Missing documents must be corrected within a set period or the application is rejected. After GDP inspection against the GDP Regulations, a permit is issued; a failed applicant may request re-evaluation once within two months of the notice.

GDP records must be identified, stored, secured, retrievable and dispositioned under a written control procedure that also protects sensitive health information under the Personal Data Protection Act. Retention must be no shorter than the device's shelf life and in any case no less than three years from the manufacturer's release date; longer statutory periods prevail.

Medical device distributors (販賣業者) must establish the good distribution practice system (運銷系統) in writing and maintain its effectiveness: determine and execute the required processes, monitor their implementation, and record GDP activities. The regulation's storage, transport, service and staffing requirements are modelled on ISO 13485. Process changes require an impact assessment on the GDP system and the device before adoption.

The first three imports of the same item, brand and origin by an importer are inspected batch-by-batch. A batch failing reinforced sampling escalates that item back to batch-by-batch inspection; a batch failing normal sampling moves it to reinforced sampling (20-50%). Items return to normal 2-10% sampling after five consecutive compliant batches whose cumulative compliant quantity reaches three times the quantity of the failed batch.

Imported devices of the categories announced in the regulation's Annex 1 are subject to border inspection (查驗) before import release: document/label checks (查核) and laboratory testing (檢驗), applied batch-by-batch (逐批), by sampling (抽批 — 2-10% normal rate, 20-50% reinforced rate), or as on-site checks at the storage location. The importer of record (報驗義務人) applies to the inspection body at the port of entry from 15 days before import, attaching the licence/registration/project-approval copy, the import declaration and other specified documents, with a 20-day correction window. Sample quantities are free and limited to testing needs.

Devices that pass inspection receive an import permit. Devices that are hard to sample at the container yard, need testing longer than five days, or are perishable/unstable may be released early under a written undertaking (具結先行放行) and stored at a designated location; misusing that release suspends the importer's expedited-release eligibility for one year. A failed inspection can be retested once within 15 days of the notice using the retained samples; after the retest window, remaining samples are destroyed, and failed devices must be re-exported or destroyed by the importer of record.

Devices may only be sold, wholesaled or retailed with a Chinese label on the smallest sales package and an accompanying Chinese instruction for use (except where announced or approved otherwise). Labels/IFU/packaging must carry ten items: product name, licence or filing number, efficacy/use, manufacture date and expiry or shelf life, model/spec or main components, warnings and precautions, owner name/address, manufacturer name/address, batch/serial number, and other announced items; specific devices may replace paper IFU with electronic IFU.

Medical Device Act (醫療器材管理法), 85 articles, promulgated 2020-01-15 by Presidential Order 華總一義字第10900004021號; effective date 2021-05-01 fixed by Executive Yuan Order 行政院院臺衛字第1100001220號 (issued 2021-02-17). No amendments since promulgation (original version in force).

From the Medical Device Act's effective date, device matters are governed by the Medical Device Act and the device provisions of the Pharmaceutical Act (藥事法) cease to apply.

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.

Official channels: the medical device registration electronic submission system (醫療器材查驗登記電子化送件系統, https://mds.fda.gov.tw/) for Class I (non-filing) registration, Class II/III registration, licence changes and extensions; and the FDA online application platform (食品藥物管理署線上申辦平台, http://oap.fda.gov.tw/) used for Class I filing (登錄). Certain Class II/III case types must be filed electronically since 2025-07-01, Class I non-filing registration electronically since 2026-07-01, with e-payment via credit card, ATM, bank counter or convenience store.

Manufacturers performing sterilisation must be equipped with sterilisation equipment and sterility-testing equipment (the latter excused where sterility testing is not performed). Packaging and labelling areas need measuring instruments, filling, packaging, sealing, label-printing and batch-number printing equipment as the work requires. Facilities and equipment used to demonstrate product conformity must be controlled, calibrated, verified, confirmed and maintained, with records kept under the QMS Regulations.

The central authority may conduct unannounced inspections of distributor premises at any time without prior notice. Municipal/county authorities may be invited to join. Inspectors must show identification, state the inspection purpose, and may take evidence-preservation measures against breaches of the Act or the GDP Regulations.

Manufacturers producing only announced low-risk device items (listed in the annex to the QMS Regulations) are subject to a reduced QMS: they must keep per-type/series device files and implement record control, complaint handling, and corrective and preventive measures, and only the listed articles (11-13, 47, 55, 63, 64, 69, 76, 77) apply; the remaining chapters do not.

Beyond the initial and periodic QMS inspections, the central authority may take product samples when conducting inspections. Sampling is free of charge and random; the manufacturer may not designate the samples, and quantities are limited to what testing requires.

Manufacturers must establish a QMS under the QMS Regulations, pass central-authority inspection and obtain a manufacturing permit (製造許可) before manufacturing; foreign manufacturing sites are subject to the same rules mutatis mutandis and the central authority may conduct on-site inspections abroad. The QMS Regulations are written with reference to ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes).

The QMS manufacturing permit is valid for three years. Extension must be applied for between 12 and 6 months before expiry, each extension being at most three years; if the applicant files in time but the authority has not decided before expiry (not attributable to the applicant), the permit remains effective until the decision date. Failed applicants may request re-evaluation once within two months of the adverse notice.

Manufacturers must establish the quality management system in writing and maintain its effectiveness, determining the processes needed, monitoring them on a risk-assessment basis, and defining their sequence and interactions, with criteria, methods, resources, monitoring/measurement and records ensuring conformity with the Act and the QMS Regulations. QMS process changes require an impact assessment on the system and the device before adoption.

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.

Class I filing (登錄) is done in the central authority's online medical device filing system: the applicant enters product name, firm and manufacturer data, classification item code, sterilisation status, QMS conformity status, uploads the documents listed in Annex 5 ('documents to be uploaded for filing of Class I medical devices for manufacture or import'), pays the fee, and receives a filing number (登錄字號).

Manufacture or import of a medical device requires registration (查驗登記) with the central authority and a medical device licence (醫療器材許可證); however, item categories announced by the central authority are marketed via the simpler filing (登錄) route instead. Devices subject to registration may not use the filing route.

Applicants may request priority review (檢具佐證文件提出優先審查) for devices that: (1) prevent, diagnose or treat life-threatening or seriously disabling disease with no suitable domestic drug, device or alternative therapy; (2) relate to rare diseases; or (3) are prioritised by government policy for R&D support and are or will be verified by domestic clinical trials, or meet urgent domestic public-health needs.

In licence and registration application review, the FDA first performs formality review (形式審查): curable defects must be completed within one month of the notice, and applications not cured in time are rejected. After formality review the FDA performs substantive review (實質審查): curable incompleteness must be completed within three months of the notice, and applications not completed in time are rejected.

Personal-use import (無需醫師或專業人員操作、由自然人自行使用之醫療器材) is limited: consumables to a six-month supply, instruments to one unit per model; expedited clearance for listed items and quantities is limited to once per half-year (travellers carrying devices in personal luggage excepted). Applications require identification, instructions for use, an undertaking not to sell or transfer, and a diagnosis certificate or prescription from a domestic or foreign care institution naming the device.

Each project approval ground under Act Art. 35(1) has defined eligible applicants: (1) prevention/diagnosis/treatment of life-threatening or seriously disabling disease — regional teaching hospitals or psychiatric teaching hospitals (with ethics approval, treatment plan, patient consent stating the device is unapproved, and quantity justification, foreign free-sale evidence substitutable for technical documentation); (2) emergency public-health response — government agencies, schools, institutions, legal persons or associations; (3) clinical trials — device firms, pharmaceutical firms or trial institutions (with ethics approval and trial documentation); (4) samples or gifts or personal use — the respective government/private/natural persons; (5) repair — repair distributors; (6) other device firms. Applications are decided on the stated grounds, benefit-risk and quantity calculation, and may carry conditions.

Central-authority project approval (專案核准) exempts manufacture/import from registration (Art. 25) in six situations: (1) prevention/diagnosis/treatment of life-threatening or seriously disabling disease with no suitable domestic alternative therapy; (2) response to urgent public-health events; (3) investigational devices; (4) samples, gifts or personal use; (5) import solely for repair where the repaired device will not be sold domestically; (6) necessary devices under Art. 34(4) announcements where manufacture/import cannot continue or supply is insufficient. Applicants include teaching hospitals, government bodies, firms, natural persons for personal use, and repairers; approval may be revoked and recall ordered (Art. 36).

Devices approved under the project regulations must be labelled per the approval letter, or marked 「臨床試驗用」 (clinical trial use), 「樣品」 (sample) or 「贈品」 (gift). For hospital, emergency-response and firm grounds, the authority may require an actual-use safety or performance evaluation report within a deadline; non-submission or safety/performance concerns allow revocation of the approval. Use and disposal must not exceed the approved purpose, restrictions, method or time limit. Except for personal-use imports and devices limited by their purpose, imported devices must be re-exported within one month after the import reason ceases, with the customs re-export evidence filed with the central authority.

Authorities may delegate device testing wholly or partly to qualified bodies. Delegates need testing capability for the items, premises, facilities and equipment, plus documented testing procedures and a quality assurance plan. The delegation contract must state the delegated items, schedule, the delegator's supervision and audit rights, confidentiality, termination and dispute mechanics. Test reports must record report numbers, delegate and delegator identity, sample description with photographs, receipt/testing dates, methods and results, the device's brand/model/serial or batch, manufacturer, licence number and shelf life, and the signatory's signature or seal.

Institutions seeking accreditation for medical device testing must run a dedicated laboratory with the necessary equipment, premises and quality system, staffed with a laboratory head, report signatories, technical head, quality head and testing personnel holding relevant degrees plus three years of testing experience (a master's degree offsets one year, a doctorate two). Applications attach proof of the conditions, capability evidence, the quality manual, testing SOPs, measurement-uncertainty evaluations for quantitative items, method validation reports and the report format with signatories' signatures. The central authority reviews documents and conducts an on-site assessment; deficiencies require an improvement report within 60 days for re-evaluation.

The accreditation certificate is valid for three years; extension is applied for between 8 and 6 months before expiry, each extension capped at three years, with unchanged documents not re-submitted. Address, method, scope or signatory changes must be filed within 30-90 days; a relocation requires a 15-day advance relocation plan. The authority conducts periodic and unannounced audits and can order proficiency testing; failing proficiency testing triggers a 15-day improvement plus retest. False data or refusal of oversight can suspend or revoke accreditation, with a one-year re-application ban after revocation.

Against administrative fine decisions, the party may submit a written objection and request review within 15 days of delivery of the decision notice (once only); if unresolved, administrative appeal (訴願) and administrative litigation are available.

Applicants whose registration, filing or clinical-trial applications are not approved may file one reconsideration request (申復) within four months of delivery of the decision, on procedural or technical grounds.

Manufacturers must operate a written product identification and traceability procedure. For device categories announced by risk level under Act Art. 19(1), a written single identification system (UDI) must be defined. Implantable-device traceability records must cover all components, materials and production environment conditions that could cause non-conformity with safety and performance requirements; implantable manufacturers must require their logistics and distribution channels to keep logistics/sales records, including parcel recipient name and address evidence.

Distributors must operate a written traceability procedure for product source and flow. The records must carry the device name, batch number, receipt date and quantity, shelf life, supplier name, consignee name/address/contact, delivery address, transport mode and acceptance temperature conditions; parcel shipments must additionally evidence the recipient name and delivery address.

For announced reporting items, firms and medical care institutions must report electronically to the central authority's system by the 20th of January, April, July and October each year (institution patient-flow data excluded). Records are kept for three years, permanently for announced reporting items. Where a device carries a UDI (單一識別碼), the UDI may replace product name, licence number and model in the reports.

Licence holders and filers keep supply-source data (product identification, batch/serial, quantity, customs declaration date for imports, manufacture and expiry dates) and flow data (consignee name, address and contact, product identification, batch/serial, quantity, delivery date, shelf life). Distributors without licences keep supplier identity plus the same product fields. Medical care institutions keep source data for devices they use, and for announced reporting items additionally keep patient-level flow data (patient name, ID number and contact) by batch/serial. Product identification comprises name, licence/registration number and model/specification; where a UDI is affixed per Act Art. 33(1)(10), the UDI replaces those fields in reporting.

For device categories announced by the central authority (risk-based), medical device firms and medical care institutions must establish and keep records of direct supply sources and distribution flows; for announced reporting items the data must be reported to the central authority (Act Art. 19). Licence holders/filers and distributors must establish the records electronically or in writing (Arts. 2-3 of the traceability regulation); medical care institutions keep source data and, for reporting items, patient-level flow data by batch/serial number (Art. 4).

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

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

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