UDI, listing & traceability by country

The opened legislation contains no UDI requirement: the National Register of Medical Devices assigns an identification number to each operator, and the registration form requires the customs nomenclature code and the GMDN or UMDN nomenclature code for each device; AKBPM publishes the device register as open data and shares it with Customs.

The Ministry of Pharmaceutical Industry's serialization strategy (version 1.0, published April 2026, based on Art. 319 of loi 18 11) states that medical devices will be subject to separate (différentes) serialization regulations from medicines; adopted technical standards include ISO/IEC 16022:2024, ISO/IEC 15418:2016, ISO/IEC 15459 3/4, ISO/IEC 15434:2019 and ISO/IEC 15415:2024.

The Sistema Nacional de Trazabilidad de Productos Médicos, created by Resolución 2175/2013, is the tool against illegitimate commerce; products are verified by GTIN (Global Trade Item Number, the 13 digit number after (01) on the label/traceability support) plus a unique alphanumeric serie (up to 20 digits, after (21)).

Under Article 47.1 part 8 of the Law on Medical Care and Services of the Population, the manufacturer carries out post registration monitoring of the safety and effectiveness of the medical devices it has created, through a system for collecting and analysing data aimed at the traceability of those devices during their use and operation and at the detection of side effects, and submits reports on it to the authorised body in the manner established by legislation.

Article 46 part 11 provides that the list (անվանացանկ) of medical devices registered in the Republic of Armenia is maintained by the authorised body. This is the national device listing; the law contains no unique device identification (UDI) system.

Sponsors of devices that do not comply with applicable UDI requirements must seek TGA consent to import and supply under sections 41MA and 41MAA of the Therapeutic Goods Act 1989. The streamlined UDI Consent to Supply application fee published by TGA is AUD 80 for the first ARTG entry and AUD 10 for each additional entry in the same application.

TGA states that Unique Device Identification (UDI) requirements became mandatory for high risk medical devices from 1 July 2026 under the Therapeutic Goods (Medical Devices) Regulations 2002.

Austria operates a national register for pacemakers, implantable defibrillators and loop recorders; implanting or treating health institutions must transmit institution, patient, clinical and implant data (model, manufacturer, serial number of devices and leads, implant parameters) electronically, pseudonymised via the sector specific personal identifier (bPK GH) unless the patient consents to named transmission; distributors (Inverkehrbringer) of the registered implants must provide the technical implant data; the register controller is Gesundheit Österreich GmbH.

submissionSurface: EUDAMED device registration and UDI database (mandatory since 28 May 2026; devices already on the market to be registered by 28 November 2026) plus the national GÖG implant register for pacemakers/ICDs/loop recorders · verifiedHighlights: Certificates must be registered in EUDAMED by the notified bodies by 28 May 2027; certificates issued after 28 May 2026 must be entered immediately.; Manufacturers (including Class III implantable custom made) need completed actor registration beforehand.

Azerbaijan's device identification obligation runs on two rails, neither of which is a UDI issuing entity regime. First, the registration Rules require the device's GMDN code in the state register: article 10.4 of the Rules lists the data entered in the state register in respect of medical devices — the device's trade name (10.4.1), type (10.4.2), risk degree (10.4.3), description of the primary and/or secondary packaging (10.4.4), accessories (10.4.5), the GMDN code (10.4.6), and where the device contains a medicinal substance, information on the active substance and its dose (10.4.7) — and article 2.1.2 defines 'tibb vasitələrinin qlobal nomenklaturası (TVQN)' as the international system of codes and terms adopted for the purpose of identifying medical devices. Second, the Regulation on the Track and Trace System for Medicinal Products approved by Cabinet Decision No. 348 of 20 July 2024 constitutes a 'Tibb vasitələri və Dərman maddələri' (Medical devices and medicinal substances) module within the state track and trace system (articles 4.1.2 and 4.2.2), whose data fields for a device include its trade name (4.2.2.1), type (4.2.2.2), risk degree (4.2.2.3), primary and/or secondary packaging description (4.2.2.4), accessories (4.2.2.5), any medicinal substance contained and its active substance and dose (4.2.2.6), pack size (4.2.2.7), manufacturer (4.2.2.8), country of manufacture (4.2.2.9), the dates of entry in the state register and of expiry of the state registration together with the registration certificate's number and date and the Azerbaijani alphabet trade name on the certificate (4.2.2.10), and the device's global identification number where available (4.2.2.11). The system is owned by the Ministry of Health and operated by the Analytical Expertise Centre (articles 2.1.3 and 2.1.4), is free to use (article 1.7), and its purpose is control of the import and circulation of the products it covers (article 1.2).

Every registered authorized representative must list all medical devices that have been imported or are intended to be imported in the future. Only listed medical devices can be applied for registration. The listing must be submitted before the registration applications, and must not be submitted as part of a registration application.

The Authority establishes an electronic system for the registration of medical devices and products and of the facilities dealing in them, in which all data relating to the device and the establishment are recorded — in particular the name of the device, its serial number, its country of origin and its shelf life. The system also carries the information required to register devices and facilities, a view of market size, information on facilities that manufacture, distribute or import devices in the Kingdom, and information on devices that will be marketed or are already in use there. Resolution 48/2020 separately defines a 'Medical Devices and Products Record' as a database of medical devices and products and the facilities used for them.

Article (7) of Resolution No. (48) of 2020, as replaced by Resolution No. (69) of 2024, provides that medical devices and products must be used in health facilities licensed by the Authority; that it is prohibited to manufacture, import or introduce any medical device or product into the Kingdom, market it or use it unless it has been registered with the Authority and a written marketing authorization has been obtained; and that it is prohibited to transport, store, resell, dispose of or export such devices or products without written approval from the Authority. The original 2020 text covered transfer, resale, disposal and export; the 2024 replacement adds import, transport and storage. Article (13) adds that facilities must dispose of devices in accordance with the requirements and that devices may not be used beyond their shelf life.

The Department (DGDA) must publish on its website the list of registered drugs with prescribed information and update it from time to time.

The State Register of Medical Products (Государственный реестр изделий медицинского назначения и медицинской техники) is a public state information resource owned by the Ministry of Health and operated by RUP CEIZ; it records device name/type, nomenclature name, applicant, producer, production sites, registration number and date, validity, status, annulment date, use area and IFU availability, and is published on the official sites of the Ministry and RUP CEIZ.

Belgium operates a Central Traceability Register under the Royal Decree of 27 September 2020: notification of the insertion or removal of implants listed in the decree's annex is compulsory for health professionals (a therapeutic relationship with the patient is required); hospitals can use an automated RCT web service and private clinics an online application. Notification had been possible for all implants since 2014 but is compulsory only for the annex listed implants.

statement: Bolivia operates no UDI system; traceability is built from the lot or serial number on the label, the lot coding of the finished product which must be described with its interpretation in the dossier, and, for biomedical equipment, notification to AGEMED of the health establishments where the equipment will be installed and an annual report of the quantity of equipment imported, manufactured and sold, with each equipment's serial number and its geographic and institutional location. · article: Numerales 2.4.6 and 2.9.1

At state level, a medical device may be placed on the market in Bosnia and Herzegovina only once it has been entered in the Register of medical devices kept by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH). Entry in the Register is an administrative procedure carried out by the Agency for the purpose of recording the devices in circulation in BiH and for the protection of public health, and it is the entry itself that confers on the applicant the right to place the device on the market of Bosnia and Herzegovina.

At the level of the Republika Srpska entity, the entity Law on Medicines and Medical Devices requires the Agency for Medicines and Medical Devices of Republika Srpska to keep a register of manufacturers and of legal persons carrying on wholesale trade in medical devices, and a register of the medical devices that are in circulation in the Republika Srpska. Circulation of medical devices that are not entered in that entity register is prohibited, and a retail seller may handle a medical device only if it is entered in the Register of medical devices for the territory of the Republika Srpska with the entity Agency.

At state level the Agency keeps a register of manufacturers and of legal persons carrying on wholesale trade in medical devices, as well as the register of medical devices in circulation in BiH. A legal person that wholesales medical devices must, before it begins wholesaling, notify its activity to the Agency; the Agency considers the notification and keeps the register of legal persons carrying on wholesale trade in medical devices.

At state level the records kept by a wholesale distributor of medical devices must be clear and available to the inspectors of the Agency, and must enable traceability of the medical product, that is a simple verification of the origin of the medical product and of the destination to which it was delivered, by systematic tracking of serial numbers. Wholesale distributors must keep records of the implementation of their written distribution procedures.

At state level the Agency informs the professional public about the medical devices entered in the Register by publishing them in the official gazettes of BiH, the Federation of BiH, Republika Srpska and Brčko District at least once every three months, by publishing the Register of Medical Devices of BiH — which is how the availability of the register to the professional public is secured — and by publishing them in a medical devices database.

At state level a wholesale distributor of medical devices must cooperate with the manufacturer or with the authorised representative in BiH in order to achieve adequate traceability of the medical device, and must ensure the traceability of medical devices in the sense of the supplier from whom they were acquired and the customer to whom they were distributed. The documentation must be kept for at least 5 years, except for implantable medical devices, for which the retention period is 10 years.

BoMRA's registration guideline requires the 'Device details' part of a medical device registration application to state the UDI number for example a GS1 number, or any other UDI relevant to the device where one is applicable to the device. It is a conditional dossier disclosure duty: the applicant declares the UDI in the application, and the guideline does not thereby require the device to bear a UDI, require a UDI to be assigned, or require the UDI to be entered in a UDI database.

BoMRA's registration guideline for medical devices (BOMRA/ER/MED/P04/G01 Iss 3.0, effective 09/12/2024) defines the Unique Device Identification (UDI) system as a system intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using AIDC and, if applicable, its HRI) based upon standard, with the UDI DI of that unique identifier being also linked to a jurisdiction specific public UDI database, and refers to IMDRF/WG UDI/N7Final:2013 for the fundamental concepts of the system. It defines the UDI as a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard that allows the unambiguous identification of a specific medical device on the market, comprising the UDI DI (Device Identifier) and the UDI PI (Production Identifier), and notes that 'Unique' does not imply serialization of individual production units.

Manufacturers must ensure UDI assignment to all devices manufactured by them or on their behalf (RDC 591/2021 Arts. 8º 9º); UDIs are assigned by the issuing entities GS1, HIBCC and ICCBBA (Art. 11 parágrafo único), and UDI data must accompany notification/registration petitions.

The UDI is a standards based unique device identifier (converted using AIDC and, where applicable, HRI), whose UDI DI is also linked to a UDI database (SIUD).

Section 12 of the Medicines Act requires the Authority to keep a register of medicinal products and cosmetic products, and Rg 2 Schedule 1 para. 8 requires the product licence holder to state the licence number on the label and package. No unique device identifier, device listing, registration number or traceability requirement applies to medical devices or IVDs in any Brunei instrument.

Under the Radiation Protection Act every person who sells a controlled apparatus and every person who purchases one must immediately notify the Authority with the other party's name, address and prescribed particulars, disposal requires prior written approval, and the Authority keeps registers of licences (s. 9). This is the only statutory traceability duty attaching to any class of medical equipment in Brunei.

Wholesale traders must, where applicable, have a batch or serial number affixed on the packaging of the medical devices.

ИАЛ (BDA) must transmit to the European database (EUDAMED), immediately upon receipt and in a standardised format, the enumerated data — including registration data on manufacturers and authorised representatives under Art. 29 and on devices registered under Chapter Two.

Wholesale traders must maintain a documented system for tracking the safety of the medical devices traded and for blocking and withdrawing them from the market.

Dealers must establish documented procedures for maintaining importation and/or distribution records and maintain such a record for each medical device, including low risk devices exempt from product registration. The record must contain enough information to permit complete and rapid withdrawal from the market — the name and address of the initial consignee, identification and quantity of devices imported or shipped, the date, and any control number including lot, batch or serial number. It must be retained for the longer of the device's projected useful life as determined by the product owner, or two years after the device is shipped.

Any person responsible for manufacturing or placing medical devices on the market of a Member State must keep all relevant records pertaining to the traceability of the device, for such period and format as the national Regulatory Authority may stipulate, and must produce those records for inspection when the Regulatory Authority requires it.

The Medical Devices Active Licence Listing (MDALL) is the public database of all licensed Class II, III and IV devices; only products appearing in the listing may be offered for general marketing purposes in Canada, and searches can be made by company name, company ID, licence name, licence number, device name and device identifier. Class I devices and ITA/special access devices do not appear.

Health Canada's first consultation on a proposed UDI system opened June 28, 2021 and closed September 30, 2021. The consultation sought feedback on potential implementation of an IMDRF aligned system; it did not itself create a UDI requirement.

Storage/distribution establishments must keep distribution records sufficient for traceability (recipient location/name/address, batch number, manufacture and expiry dates, quantity distributed) to support complaints, adverse events and market recall; traceability records must be kept for no less than the device's shelf life, and never less than 2 years from product release; records must be available for inspection.

Establishments must keep a traceability registry for all implantable devices considered high risk for the patient, specifically: cardiac implants and central circulatory system vascular implants; central nervous system implants and neurostimulation systems; spinal implants; hip, shoulder and knee prostheses; mammary implants; intraocular lenses; auditory implants; intragastric balloons; and others designated by ISP resolution. For implantable devices the minimum record retention period is 10 years.

NMPA operates the national UDI database; registrants/holders must upload the product identifier (UDI DI) and related data to the database, per the UDI System Rules (NMPA Announcement No. 66 of 2019).

Following implementation across all Class III devices (incl. IVDs) and 103 Class II device types, all Class II devices (including IVDs) and all Class I IVDs produced from 2027 06 01, and all Class I devices produced from 2029 06 01, must carry a UDI.

UDI is implemented in batches: from 2021 01 01 the first 9 categories / 69 types of Class III devices; from 2022 06 01 all other Class III devices including IVDs; from 2024 06 01 the third batch covers selected Class II devices (high volume single use, centralized procurement and medical aesthetics products), devices in scope produced from that date must carry a UDI, and new registration applications must submit the UDI DI of the smallest sales unit in the registration system.

Establishments that import or market devices must keep documentation of products distributed or destined for use in Colombia for traceability, containing at minimum: trade name, model, serial and/or lot number, acquisition date, shipping/supply date, and identification of the first customer.

After an 18 month implementation period from publication, holders of existing registrations had phased deadlines counted from the end of that period: 12 months for class III, 18 months for class IIb, 24 months for classes IIa and I (same months for IVD categories III/II/I); registrations obtained after the implementation period must report the UDI DI before commercialization with no transition.

UDI DI/semantic standard reporting is done by titulares of valid registrations on the platform estandar.invima.gov.co before commercialization, reporting basic (UDI DI, GMDN code and term, registro sanitario, issuing agency), regulatory and commercial attributes; after paying tariff 4003 1 INVIMA issues an electronic oficio. UDI DI on the physical label is not required.

To market devices in Colombia, the titular of the registro sanitario or permiso de comercialización must obtain the UDI DI code and complete the reporting procedure (Capítulo III of Resolución 1405 de 2022); the code uniquely identifies human use medical devices and IVDs and is issued by authorized agencies (GS1, HIBCC, ICCBBA, IFA, ALI HEALTH, ZIIOT).

EMB labels must bear the product identification code (or declared model), the lot number, and the EMB registration number except for products exempt from registration.

Manufacturers, importers and distributors must implement a traceability system to follow EMB through the commercialization, supply and use chain, with special emphasis on implantables, available for CNTV consultation; for implantable EMB a system must guarantee completion and registration of the traceability form so the implanted device can be identified throughout the person's life.

The AIRP has adopted Décision n° 0015/AIRP/DG instituting the system of listing/declaration of medical devices in Côte d'Ivoire (signed at Abidjan on 15 September [2025] by the Directeur Général, Dr Assane Coulibaly; published on the AIRP official document index). Article 2 makes the introduction of any medical device into Côte d'Ivoire subject to a prior declaration by each actor in the supply chain to the AIRP; Article 3 provides that no medical device may be imported, distributed or sold in Côte d'Ivoire, whatever its class, unless it has first been declared to the AIRP, and allows derogations from declaration for certain devices where public health necessity requires; Article 4 charges the Directeur de l'enregistrement des produits pharmaceutiques and the Directeur de l'Inspection et de la Surveillance du marché with execution, with effect from signature.

Failing a traceability system established by the competent authority, the manufacturer must develop and operate an identification system permitting adequate traceability from manufacture to final use of the medical device. Importers/exporters and distributors must apply the traceability system defined by the competent authority or, failing that, the manufacturer's. These duties sit alongside the actor level 'listing' declaration required before a device is introduced into the country.

By Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, the Commission confirmed that the EUDAMED actor registration system, the UDI and device registration system, the notified bodies and certificates system and the market surveillance system are functional and meet their functional specifications. Under the six month rule introduced by Regulation (EU) 2024/1860 into MDR Article 123(3)(d) and IVDR Article 113(3), the obligations and requirements relating to those electronic systems apply from six months after publication of that notice, i.e. from 28 May 2026. From that date devices must be registered in EUDAMED before being placed on the Union market, and the parallel national registration regimes cease to be sufficient.

Under MDR Article 123(3)(e) as inserted by Regulation (EU) 2024/1860, no later than 12 months after publication of the Commission's notice, manufacturers must ensure that the information to be entered in EUDAMED under MDR Article 29 is entered in that system, including for devices for which the manufacturer has undertaken a conformity assessment under Article 52 and for devices placed on the market under Article 120(3), (3a) or (3b) (unless already registered in EUDAMED). With publication on 27 November 2025, that deadline is 28 November 2026. HALMED reproduces the same deadline for Croatia: the additional six month period for registering devices placed on the market before the mandatory use date runs to 28 November 2026.

In exercising its functions CECMED uses the Global Medical Devices Nomenclature (GMDN) as the internationally recognized device nomenclature system, and favors the Unique Device Identification (UDI) system, as approved in national legislation, as a means to improve device traceability.

Following Commission Decision (EU) 2025/2371, the use of the first four functional modules of the European Database on Medical Devices (EUDAMED) has been mandatory since 28 May 2026 in the application of Regulations (EU) 2017/745 and 2017/746: actor registration (Articles 30 MDR / 27 IVDR), the UDI database and electronic device registration system (Articles 28–29 MDR / 25–26 IVDR), notified bodies and certificates (Articles 57 MDR / 52 IVDR) and market surveillance (Article 100 MDR / 95 IVDR). Economic operators — manufacturers, authorised representatives and importers — must register in the actor module, manufacturers must register their devices in the UDI database and the device registration module, and notified bodies must attach their issued certificates in the notified bodies and certificates module.

CYMDA lists the importer registration duty in EUDAMED (Article 31(1) MDR / Article 28(1) IVDR) and the product traceability obligation (Article 25 MDR / Article 22 IVDR) among the duties that apply to operators importing and distributing medical devices in Cyprus, alongside the obligations of an importer acting as manufacturer (Article 16 MDR/IVDR) and the obligations of economic operators involved with class III implantable devices (Article 28(8) MDR).

Under MDR Article 123(3)(e) as inserted by Regulation (EU) 2024/1860, no later than 12 months from the date of publication of the Commission's notice that the UDI and device registration system is functional, manufacturers must ensure that the information to be entered in EUDAMED under MDR Article 29 is entered in that system, including for devices for which the manufacturer has undertaken a conformity assessment under Article 52 and for devices placed on the market under Article 120(3), (3a) or (3b), unless a device already registered in EUDAMED has undergone a conformity assessment under Article 52. With publication on 27 November 2025, that deadline is 28 November 2026; it applies to devices that are also placed on the market from six months after publication of that notice, i.e. from 28 May 2026.

A free sale certificate application must include the basic UDI DI of the device model in the UDI system (MDR Art. 27 / IVDR Art. 24), where one has been assigned, and state whether an electronic or paper certificate is requested.

A healthcare provider must retain the unique identification (UDI) of devices supplied to it, except class I devices and class A IVDs, and present this information to SÚKL on request. Where a class IIb or III device is used in care, the provider must record this in the patient's medical documentation.

Danish health institutions must hand over the implant card and make the MDR Article 18(1) information available to patients who have received an implant.

submissionSurface: EUDAMED for manufacturers, importers and authorised representatives; Danish national electronic register for distributors and specialty retailers; DKMA publishes bruttolister (gross lists) of notified class IIa III manufacturers and registered specialty retailers · verifiedHighlights: Distributors and specialty retailers are not registered in EUDAMED ('Distributører og specialforretninger skal ikke registreres i EUDAMED').; BEK 1731/2025 §§ 12(6), 13(5), 14(5), 15(5): DKMA records the notified data in an electronic register usable for market surveillance and publishes company lists on its website.

statement: Decreto 246 06 obliges the technical director of an importing establishment to establish traceability records of the products brought in and to record which establishments they are destined for, in accordance with good distribution practices, and obliges distribution establishments to keep absolute control of the provenance of the products and of their distribution by lot number or identification key — which the reglamento expressly names 'control y trazabilidad'. The importing establishment's technical director additionally guarantees the conformity of each product, lot by lot, to the specifications of the certificate of analysis. · article: Art. 105, Párrafo (y primer párrafo); Art. 166(b)

Ecuador has no general UDI mandate for medical devices; traceability of implantable devices relies on patient implant identification cards: holders/distributors of implantables must guarantee at least three cards per device (patient, clinical record, distributor/holder), and the implant card must record establishment, patient identification, implant date, ECRI/GMDN code and generic name, commercial name, lot/serial, manufacturer, importer, registration number, and 'UDI, cuando aplique' (UDI when applicable).

For traceability, manufacturers must use international device nomenclature UMDNS (ECRI) or GMDN for coding devices (an alternative nomenclature from a high vigilance agency or WHO is exceptionally allowed when no code exists). ARCSA publishes on its website the updated list of devices with valid, suspended and cancelled sanitary registrations.

The manufacturer or its agent must submit and maintain data in the Egyptian UDI Database, validate it during submission and annually, and ensure UDI DI data is available at the time the device is placed on the market; record updates for changes not requiring a new UDI DI are due within 10 working days. Data must be in English, with an Arabic trade name for lay/home use devices, and includes the agent's national registry number and the device's national registration number.

Manufacturers must assign UDI (UDI DI plus UDI PI(s)) to devices, accessories and IVDs supplied to the Egyptian market under Chairman Decree 499/2021; GS1 standards apply by default and other IMDRF designated issuing agencies may be used if the brand owner/agent notifies EDA. Research use, investigational and custom made devices are out of scope.

The Unique Device Identification system described in Part C of Annex VI to Regulation (EU) 2017/745 allows identification and facilitates traceability of devices, other than custom made and investigational devices, and consists of a UDI device identifier specific to a manufacturer and a device and a UDI production identifier identifying the unit of production. Registration of devices and of the UDI data is made in EUDAMED, whose UDI/device module is among the four EUDAMED modules mandatory from 28 May 2026.

The statute prohibits any person from importing or placing into use any medicine or medical device unless its labelling contains a barcode. This is a statutory labelling requirement and is the only express barcode obligation found for devices; it is separate from the UDI assignment and traceability duties in the GMP guideline.

The manufacturer must document traceability procedures covering at least the origin of the product, material and parts, the history of processing, distribution and the product location after delivery, and must define the extent of traceability and the records to be maintained. Where traceability is needed the manufacturer must establish a unique identification system for the product and maintain traceability records; it must require its distribution service suppliers or distributors to maintain distribution records that allow traceability and are available for inspection, and the established traceability system must enable ease of product withdrawal from the market. Records required for traceability of implantable medical devices must include records of components, materials and work environment conditions that could cause the device not to satisfy its safety and performance requirements.

Under the Ethiopian medical device GMP guideline the manufacturer's organisation must document a system to assign unique device identification to the medical device. The same clause requires documented procedures for product identification and for identifying product status against monitoring and measurement requirements throughout the manufacturing process, with records retained across the entire product lifecycle from production and storage to installation and servicing.

Before placing a device (other than custom made) on the market, the manufacturer must assign to the device and, if applicable, all higher levels of packaging a UDI created in compliance with the rules of a Commission designated issuing entity, and must ensure the Annex VI Part B data are correctly submitted and transferred to the UDI database; before applying to a notified body for higher class devices the Basic UDI DI must be assigned and provided (Art. 27(3), Art. 29(1) MDR).

The obligation to place the UDI carrier on the label (Art. 27(4) MDR) applied from 26 May 2021 for implantable and class III devices, from 26 May 2023 for class IIa and IIb devices, and from 26 May 2025 for class I devices; reusable devices that must bear the UDI on the device itself have later dates under Art. 123(3)(g).

As part of their monitoring system, social and health care units and other professional users that are legal persons or self employed professionals must record and keep the UDI (MDR Art. 27) of class III implantable devices (MDR Art. 51(1)) delivered to them, implanted in patients or otherwise passed on; the duty of health care units to record the UDI electronically by appropriate means applies from 26 May 2023 (59 §).

Use of the first four EUDAMED modules (Actors; UDI/Devices; Notified bodies and certificates; Market surveillance) is mandatory since 28 May 2026; devices marketed under directives 93/42/CEE or 90/385/CEE (MDR Art. 120 legacy) and devices previously registered nationally with ANSM must be registered in EUDAMED before 28 November 2026; changes and cessation must also be recorded, and ANSM encourages use of the EMDN nomenclature.

Georgia's product traceability layer runs through the economic operator. An economic operator must indicate its own name, registered trade name or registered trademark, and contact information including its postal address, on the product, on its packaging or in the accompanying documentation, in compliance with the requirements of the relevant technical regulation. When placing a product on the market or ensuring its availability it must ensure that the product complies with the technical regulation and that the relevant technical documentation has been prepared, and must keep that documentation for the period set by the same technical regulation for the purpose of submitting it to the Market Surveillance Agency. On the Agency's request it must provide the documents and information relating to the product determined by Georgian legislation, including information about the economic operators involved in the product's supply chain on the market. Separately, a manufacturer must provide a distributor with complete information about product related risks so that the distributor can communicate that information to a third party, and where a manufacturer or distributor knows or could have known that products it placed on the market carry risks that fail to comply with Georgian safety requirements it must immediately notify the authorised body with data identifying the product or its lot/group, full information on the risks, full information allowing the product to be tracked, and a description of the measures needed to avoid the risk.

From 28 May 2026 the EUDAMED UDI/Devices module must be used for registration of newly placed products; capture of new product notifications via DMIDS was deactivated on 28 May 2026, and products already on the market must follow by 28 November 2026.

submissionSurface: EUDAMED UDI/Devices module (mandatory for new devices from 28 May 2026; legacy devices by 28 November 2026); DMIDS was the national listing surface under § 96/96a MPDG until 28 May 2026 and is being frozen as an archive · verifiedHighlights: DMIDS capture of new product notifications deactivated on 28 May 2026.; No automatic data transfer from DMIDS to EUDAMED.

The Authority keeps separate registers for registration of regulated products including medical devices; the Medical Devices Department maintains the medical devices register.

submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS, services.eof.gr/gremdis) for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms.; EOF separately maintains medical device notification, vigilance and distribution/production materials.; National listing surface verified on EOF e services page; UDI itself is EUDAMED based (EU level).

For the products within AG 712 99's scope — which include material de curación, medical surgical material, dental products and equipment, and laboratory diagnostic reagents — import is permitted only if the product is registered or inscribed with the DRCPFA and only through establishments holding a current sanitary importer licence. The customs policies and forms (pólizas y formularios aduaneros) must be submitted to the DRCPFA for authorisation beforehand, and before that authorisation they must be signed and sealed by the establishment's technical director, with the corresponding registration or inscription number(s) appearing on the invoices attached to those documents. The customs authorities of the Republic admit only products duly registered or inscribed.

The LRP must operate a tracking system that tracks high risk devices specified in GN 01 Appendix 1 down to patient level; where patient level tracking is not possible, tracking to user facility level is required.

The LRP must keep supply records enabling tracing of devices imported and supplied in Hong Kong, retained for not less than the lifetime of the device as defined by the manufacturer, or seven (7) years from the date of product supplied, whichever is longer.

Since 1 January 2014, healthcare providers must report implantation related interventions (implantation, removal, exchange) to the Central Implant Register (Központi Implantátumregiszter, KIR) at impreg.neak.gov.hu, operated by NEAK, within 8 days of the patient's discharge; the data list under Eütv. 101/C § a)–g) includes lot/serial number, manufacturer, distributor, the performing physician/provider and the device UDI.

Health institutions and health professional offices must each keep an electronic register of the UDI of Class III implantable devices they have supplied or received (Annex VIII of the MDR), and that register must record which patient received the implant, with name, kennitala and other identifiers. Economic operators must keep an electronic register of the UDI of Class III implantable devices, and of devices under Article 27(11)(a) of the MDR, that they have supplied or received; the patient identity requirement does not apply to the operators' register. Lyfjastofnun may demand access to the institution and office registers, including patient identifiers.

The unique device identification system is described in Part C of Annex VI of the Regulations and identifies and facilitates the traceability of devices other than custom made and investigational devices; the details follow Chapter III of the Regulations. Before placing a device on the market, the manufacturer must assign a UDI to the device and, where applicable, to all outer packaging, must ensure that the Annex VI Part B information is correctly submitted and entered into the UDI database referred to in Article 28 of the MDR, and must keep an up to date list of all UDIs it has assigned.

Rule 46 (as substituted by G.S.R. 918(E) with effect from 31 December 2021) requires every device approved for manufacture or import to bear a unique device identification from a date and in a manner to be specified by Central Government order. The substituted rule does not itself establish a calendar date for UDI marking.

Registered devices and PKRT (domestic and imported), licensed distributors (IDAK) and producers are listed in the official public registry e Info Alkes dan PKRT (infoalkes.kemkes.go.id), which provides a permit check (Cek Izin) search; the izin edar number (NIE) must appear on the product label.

Product registration in the directorate's system uses GS1 GTIN codes; product variants are registered in a mother child (مادری فرزندی) structure, adding each distinguishing item under the parent record's 'افزودن GTIN' function.

All medical equipment and supplies must be identified (شناسه‌گذاری) by importing and manufacturing companies; until identification is done the item's IRC is deactivated and not shown on imed.ir, currency allocation processing for the IRC stops, and the IRC is removed from the list sent to the Central Bank.

TTAC (Track & Trace & Authentication Control) is the FDA system creating a tracking and tracing regime for health products — including medical equipment and supplies — along the whole supply chain, with public authenticity checking of products.

Devices other than custom made and investigational devices carry a Unique Device Identification consisting of a UDI device identifier (UDI DI) specific to a manufacturer and a device and a UDI production identifier (UDI PI) identifying the unit of device production; the UDI is placed on the label of the device or on its packaging and is stored, together with the related device identifiers, by economic operators, health institutions and healthcare professionals under the conditions laid down in Art. 27.

The AMAR register (פנקס אמ"ר) at registries.health.gov.il/MedicalDevices is the database of all approved medical accessories and devices, with open public access.

Health institutions (istituzioni sanitarie) and health professionals must record and retain the Unique Device Identifier (UDI) of the devices they have received; detailed arrangements are set by one or more Ministry of Health decrees adopted with the Ministry of Economy and Finance, after consulting the State Regions Conference.

To enable traceability of implantable devices on the national territory, economic operators must provide, as prescribed, the data required by the decrees governing the implantable device registries under Art. 12(10) of DL 179/2012 (converted with modifications by Law 221/2012) and Law 86/2012, pursuant to MDR Art. 108.

Listing surface is EUDAMED (UDI/Devices registration module), which the Ministry of Health page describes as available for registration on a voluntary basis since 4 October 2021 pending the MDR Art. 34(3) mandatory use notice; national traceability duties (health institutions recording received devices' UDI, Art. 15(1)) apply in parallel.

Device containers/wrappers must bear a number, symbol or code (符号) — by an Ordinance prescribed electronic/ICT method — enabling retrieval of the published precautions (注意事項等情報); this is the statutory basis for GS1 code (UDI style) device identification.

PMDA operates electronic package inserts (電子添文) and a registration linking device/IVD package inserts with GS1 codes (introduced by MHLW notification of 2020 11 11, 薬生安発0311第1号), enabling code based retrieval of current IFU information.

The testing and circulation regime operates per batch (تشغيلة): a batch is a defined number of production units of a supply, sterilant, disinfectant or cosmetic manufactured from the same materials under the same conditions in one run or an integrated series of runs, homogeneous and carrying a number (batch number).

Upon completed registration, re registration or amendments, the state body enters the information into the State Register of Medicines and Medical Devices; under the EAEU route decisions are published in the unified register of medical devices registered within the EAEU.

statement: The A&T standard's product dataset for medical devices includes a 'Unique Device Identification (UDI)' field described as a series of alpha numeric characters assigned by the PPB to a medical device, which 'will be the national unique code (descriptive, logical and meaningful)'. The device field list in the same annex also carries the manufacturer's own identifiers alongside it — device family, device group, device class (A to D), GMDN name and code, make/model, and a manufacturer assigned serial number for equipment — so the national identifier is a distinct field additional to the manufacturer's model and serial numbers. · identifierIssuer: Pharmacy and Poisons Board · dataset: Annex I, Products (Pharmaceuticals and Medical Devices) · companionFields: device family; device group; device class A D; GMDN name; GMDN code; device accessories; make/model; serial number; quality and standards (CE, KEBS, ISO 13485)

statement: Kenya's national authentication and traceability standard imposes the mandatory unit level unique identifier rule on medicines. Section 2.2 (Standards) requires all serialized units of medicines (individual packages) to be assigned a unique identifier (Global Trade Item Number plus Serial Number) compliant with GS1 standards — GS1 128 with Application Identifier 01 and a unique 20 digit serial number. Medical devices are inside the standard's product scope but are not the subject of that mandatory rule: the only place devices appear in the rollout is Phase 4 (Full Scale Serialized Authentication and Traceability), whose requirement is to '[e]xtend the serialization requirements to all regulated medicines and potentially other high risk medical devices'. On the face of the standard, therefore, no mandatory serialization or UDI carrier obligation for medical devices is in force. · mandatoryFor: medicines (individual saleable packages) · deviceObligation: none stated; Phase 4 (full scale rollout) names 'potentially other high risk medical devices' as a future extension · identifierStandard: GS1 128 with Application Identifier 01 (GTIN 14) plus a unique 20 digit serial number; batch/lot AI (10), expiry AI (17), serial AI (21)

statement: The A&T standard requires verification and authentication to be performed at every location throughout the entire supply chain — manufacturer, importer, distributor/wholesaler — as the first requirement of its A&T methodology, and requires every change of ownership in the supply chain to be accompanied by traceability documentation or verification and authentication. PPB has chosen the centralised model: all A&T data (unique identifiers — GTIN, serial numbers, SSCC — product information such as name, batch number and expiry date, and transaction data for manufacturing, distribution and dispensing) are stored in a centralised, secure database managed by the PPB, either directly or with A&T service providers, and verification of identifiers may be carried out by government agencies (national and county), supply chain participants, medical professionals and patients against that repository. · verificationPoint: every location in the supply chain; every change of ownership · repository: centralised PPB managed database · whoMayVerify: government agencies (national and county), supply chain participants, medical professionals, patients

statement: Healthcare institutions must store electronically, for at least two years, the unique identifiers of the active class IIa, active class IIb and active class III medical devices supplied to them. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: postmarket surveillance · localApplicationRequired: No · targetDecisionRetained: No

Medical devices must be identified according to the list established by the MOPH, which is based on the GMDN coding system; a unique code is assigned to every device appearing on the LNMDI list, and those codes must be communicated to the customs directorate in order to standardise the identification of these devices.

For post market surveillance and traceability of devices placed on the market, registers must be kept by suppliers and by users (public and private care establishments). The supplier must keep a register gathering information on all the medical devices it has placed on the market. The hospital must keep a register containing information on all the devices used on patients, clearly stating the patient and device identifiers, must ensure that staff complete the medical record adequately, and must give the patient an information sheet on the device used on discharge.

Health institutions (IVDR Art. 2(29)) must capture and store, preferably electronically, the UDI (IVDR Art. 2(15)) of the IVDs they have procured, insofar as those products belong to products, product categories or product groups covered by measures under IVDR Art. 24(11)(a).

eeaChannel: EUDAMED (EU level) · nationalDelta: Health institutions in Liechtenstein must capture and store the UDI of procured IVDs (EWR IvDV Art. 12) · customsChannel: Swissmedic registration/listing for the customs territory per Verwaltungsvereinbarung Anhang Ziff. 2/5

VASPVT submits data to the European medical devices database EUDAMED under Regulation (EU) 2017/745 and the IVD regulation.

Healthcare institutions must submit data on discontinuation of use of non implantable and IVD devices to VASPVT, using the prescribed form, no later than 60 calendar days from the day of discontinuation of use.

Healthcare institutions must submit in use (non implantable and IVD) device data to VASPVT, using the prescribed form, no later than 30 calendar days from the installation day of the device.

From 28 May 2026 the use of EUDAMED becomes mandatory for many MDR/IVDR obligations, including actor registration, UDI/device registration, certificates and market surveillance; economic operators are strongly encouraged to complete their EUDAMED registration and transfer their data as early as possible.

Manufacturing plants must register (in traceable form) import, acquisition, manufacture, export, wholesale, complaints, recalls, returns and destruction of devices, completing entries for import/acquisition/export/wholesale/complaint/recall/return/destruction within 72 hours; IIb/III import export and wholesale premises must keep equivalent records including stock levels. Records and files are kept for 1 year after the device's use term or expiry date, but not less than 3 years.

ISAF keeps a register of registered medical devices recording: device name, registration number, registration holder name, and registration status.

The medical device Register (MDAR) is available for public access (searches/copies on request against the Fifth Schedule fee); every establishment must maintain distribution records for each device manufactured, imported, exported or placed on the market and provide them to the Authority on request.

UDI is not yet mandatory in Malaysia. MDA ran a UDI readiness pilot survey in two phases (Class D establishments 7 June 31 July 2024; Class B establishments 15 August 15 October 2024); survey results will determine the implementation timeline and updates in MeDC@St 3.0+. UDI means a numeric/alphanumeric code of Device Identifier (DI) plus Production Identifier (PI).

Where applicable, the Basic UDI DI and the UDI DI of a device, as written on its EU declaration of conformity, must be entered on the Maltese device notification sheet, along with the MMA reference number, product brand name, generic name, catalogue number, device type and class. Operators also supply their Single Registration Number (SRN) generated by EUDAMED, where applicable, on both the organisation registration and the device notification. Importers and distributors sourcing from third countries must register as actors in EUDAMED as well as registering with the Malta Medicines Authority.

COFEPRIS publishes the Visor de Registros Sanitarios de Dispositivos Médicos (live from 20 08 2026) at registros.cofepris.gob.mx/BRSDM/default2.aspx, giving the public and health institutions open access to valid device registrations, continuously updated; holders may submit per registration corrections within two weeks of the launch via the COFEPRIS format to digipris@cofepris.gob.mx.

On granting a registration, the Secretaría assigns each device an alphanumeric key with the letters SSA, which the registration holder must express on product labeling as the applicable NOM provides; the same key is preserved across prórrogas.

In the CE track dossier the fields "Basic UDI DI" and "UDI DI" are recommended, and the GMDN field is optional and is selected from the lists available in the system. AMDM presents this as giving economic operators flexibility and facilitating the transition to the use of the European systems of medical device identification. No Moldovan UDI database, issuing entity or labelling UDI duty was found in the instruments retrieved.

The Law requires the serial number, standard code and quantity of each batch of medicines and medical devices to be entered into the electronic database on each occasion. Entry of the registration or listing in the electronic database is what makes it effective, and the listing metadata recorded for equipment and consumables includes the product name and the instructions for use, held and updated in the electronic information database.

A manufacturer must, among the special conditions it has to meet, establish and maintain a post market surveillance plan for the device — except for a device made to order for a particular patient or intended for clinical investigation — and keep orderly records of non conforming devices and of devices withdrawn from trade; and it must keep a record of the type and quantity of medical devices sold in Montenegro. It must also have at least one employee responsible for quality and vigilance, and keep the technical documentation and declaration of conformity for at least five years, and for implantable medical devices at least fifteen years.

A specialised retail outlet may carry on retail trade in medical devices only if it meets the prescribed conditions, one of which is that it keeps a record of the type and quantity of medical devices sold in Montenegro, by individual package; it must also have an employee responsible for the receipt, storage, keeping, sale and dispensing of medical devices, and appropriate premises and equipment. Separately, where it is rational and feasible, the medical device and its components must be marked with the batch number, so that all necessary measures can be taken if potential risks from the device or its components are identified.

An importer of a medical device from a non EU state may place on the market only a device for which conformity assessment has been carried out under the Law, and before placing it on the market the importer must ensure that, among other things, the manufacturer has assigned the medical device a unique device identification number (UDI), that is a barcode, where applicable. Additional conditions and the manner of import from non EU states are prescribed by the Ministry.

The manufacturer, the authorised representative or the importer supplies the information needed for the registration of medical devices and legal persons, as well as the data that are submitted for the UDI database and the UDI system. The same limb appears in the essential requirements for general and active implantable medical devices and for in vitro diagnostic medical devices, and the document of conformity must carry the device's basic UDI DI as well as an unambiguous reference enabling the identification and traceability of the device.

Persons responsible for establishments manufacturing, importing, exporting and distributing medical devices, health establishments and health professionals must apply traceability rules to certain medical devices according to their degree of danger, within the limits of their respective responsibilities. The list of those devices and the rules governing their traceability are fixed by regulation. No unique device identification (UDI) system is established by loi 84 12.

DFDA publishes the list of approved medical device import registrations (e.g. January June 2026) as a downloadable spreadsheet with columns: No., Company Name, Product Name, Brand Name, Name and Country of Legal Manufacturer, Name and Country of Physical Manufacturer.

The list of companies and medical devices holding import certificates is announced weekly on www.fda.gov.mm.

submissionSurface: EUDAMED UDI/Device registration module is the official device listing surface, mandatory from 28 May 2026 (Besluit (EU) 2025/2371); devices already on the EU market before that date must be registered by 28 November 2026; the national NOTIS system continues only for custom made device registration and mutations of existing notifications · verifiedHighlights: Registration in EUDAMED required before the first unit is placed on the market from 28 May 2026.; Legacy devices (placed on the EU market before 28 May 2026) must complete EUDAMED UDI/Device registration by 28 November 2026.; Custom made devices are registered in NOTIS (art. 2 Regeling medische hulpmiddelen).

The 2003 Database Regulations establish no UDI scheme; device traceability rests on the WAND entry — GMDNS product description for all notified devices plus a unique product identifier (trade/brand name) for Class III and Class AIMD devices. Medsafe uses the WAND database to identify all sponsors of a device when a safety issue arises.

The Declaration of Conformity must contain a Global Medical Devices (including IVDs) code and term for the device(s), where available.

Importers and distributors must communicate Field Safety Notices and maintain distribution records as their post market responsibility, supporting device traceability through the supply chain.

Traceability of medical devices in North Macedonia rests on national instruments rather than on a UDI system: the identification code that must appear on the device label (Article 132(2)), the list of devices with their classification recorded at wholesale register entry (Article 128), and, for a parallel imported device, the identification cipher given as an EAN or BAR code (Article 131 а(3)). No obligation to assign a UDI DI, to upload to EUDAMED or to maintain a UDI database was found in the Law or in the device rulebooks.

submissionSurface: EUDAMED · details: Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.

Medical device manufacturers, authorised representatives, importers and distributors may be subject to listing requirements; a listing party may contract another party to complete the listing on its behalf while retaining responsibility.

The device information section of the dossier must include method of traceability, GMDN nomenclature code, HS code, manufacturer device ID, serial/model number and batch/lot reference for accessories; wholesale stores must operate a digital inventory system with batch level traceability from receipt to distribution, with separate classification for recalled, damaged and expired products.

Under rule 56(1), a qualified practitioner who places an implanted medical device into a person's body must maintain records of the patient's name, address, phone and identity card number, the date of the procedure and the operator or surgeon, the name and description of the implant, and the lot or batch number of the implant; contravention is an offence punishable under the DRAP Act (rule 56(2)).

Traceability of implantable medical devices is mandatory (DE 490, Chapter IV, Art. 62). Health institutions must complete the Registro Nacional de Dispositivos Médicos Implantables y Prótesis form in full, attach it to the patient's clinical record, and submit reports quarterly to DNDM's vigilance department (vigilanciadndm@minsa.gob.pa), covering all devices implanted since January 2019.

DNDM must maintain an updated, public database on MINSA's website covering Licencias de Operación, Certificados de Libre Venta, Registros Sanitarios, Certificados de Criterios Técnicos, BPM/BPA/BPD certificates, safety alerts, voluntary market withdrawals and other pertinent information, respecting confidentiality where applicable.

Implantable devices require an implant card (tarjeta de implantación). The resolution lists the categories as cardiac and central circulatory vascular implants, central nervous system implants, spinal implants, hip prostheses, knee prostheses, breast implants, intraocular lenses and hearing implants. The card is issued in triplicate by the product supplier, with copies for the clinical history, the patient and the registration holder.

The ANM establishes and publishes a single product identification standard for pharmaceuticals, devices and sanitary products, mandatory nationwide; establishments that manufacture, import, distribute and market devices must implement a system to achieve traceability of products placed on the national market, under conditions set by the Reglamento. The application form requires the device's identification code under the international standard.

The list of all approved CMDRs and CMDNs is posted on the FDA website, giving a public registry of authorized devices.

Device labels must reflect lot number, batch number or serial number, whichever is applicable, for all codes included in the application; label artworks for all packaging layers must be submitted.

Public health institutions and other professional or business users of devices must retain and store, in electronic form, the UDI codes of devices, systems and procedure packs supplied to them, where those codes were assigned under MDR Art. 27(8)/IVDR Art. 24(8); the health minister may extend this duty by regulation.

Distributors must electronically transmit to INFARMED, for coding and supervision purposes, their device list including the UDI DI of implantable devices supplied (recording UDI DI of other devices is possible), plus manufacturer/mandatário identification, labelling and IFU.

Any public or private entity using implantable devices must record and keep, preferably electronically, the unique identification of the implantable devices used or supplied to them.

Devices already registered in EUDAMED are recorded in SIDM using the EUDAMED data with the UDI DI/EUDAMED ID; after upload of labelling, IFU and declaration the CDM device code is automatically assigned and the record becomes searchable in the public InfoDM portal.

Public and private health institutions in Romania must store and keep, in electronic format, the UDI of implantable medical devices they supplied or which were supplied to them.

Economic operators must electronically store and keep the UDI of IVDs supplied to and by them once the Commission adopts the implementing act (IVDR art. 24(8), (11)(a)); public and private health institutions must likewise store the UDI of such IVDs supplied to them.

submissionSurface: EUDAMED (actor and device registration, UDI database) validated by ANMDMR, plus the Romanian national device database (baza națională de date) with public search on anm.ro · verifiedHighlights: ANMDMR verifies EUDAMED data, validates/rejects actor registration and transmits the SRN.; Registered data are stored in the national device database per Art. 14 OUG 46/2021.

Identification marking (marking with identification means, Chestny ZNAK / GIS MT) is mandatory for listed device categories with staged dates: wheelchairs from 01.09.2024 (Decree No. 885/2023; rehab TSR per Decree No. 744/2024); orthopedic shoes, air disinfectant purifiers, hearing aids, coronary stents, CT scanners, canes/crutches/supports/handrails, prosthetic parts, anti decubitus mattresses and cushions, special excretion disorder products, and sanitary chair stools from 01.09.2025; incontinence hygiene products and gloves from 01.03.2026; experiment items (syringes, infusion systems, napkins, test tubes, respiratory equipment, neonatal incubators, fillers/cosmetic threads, medical masks) become mandatory from 01.09.2026 under Decree No. 620 of 17.05.2024 as amended by Decree No. 204 of 28.02.2026; stage II (glucose meters, test strips, tonometers, express tests) runs 02.03–31.08.2026 and stage III (IVD reagent kits) 02.04.2026–28.02.2027.

On registration Roszdravnadzor enters a record in the State Register of Medical Devices (государственный реестр медицинских изделий), the public listing of registered devices and their manufacturers, searchable via a Roszdravnadzor e service.

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

Medical devices imported before the applicable UDI compliance date can be distributed for 1 year after the compliance date.

UDI requirements apply to all medical devices, medical supplies and accessories placed on the Saudi market and not exempt from marketing authorization, and to manufacturers and Authorized Representatives. The national UDI database (Saudi DI) has been launched and effective since 1 October 2020; required data must be submitted to Saudi DI and UDI must be on the device before the applicable compliance date (phased by device class).

Senegal's device decree creates a national data collection mechanism called 'listing' and a manufacture to final use traceability duty, but it does not create a UDI issuer or a public UDI database. Art. 2 defines: 'listing : processus de recueil d'information relative aux dispositifs médicaux (DM) en vue de constituer une base de données dynamique pour tous les acteurs de la chaîne d'approvisionnement sous la responsabilité de la structure en charge de la réglementation pharmaceutique' — i.e. the collection of information on medical devices to build a dynamic database for all supply chain actors, under the responsibility of the pharmaceutical regulation structure. On the manufacturer's side, the sixth indent of art. 34 requires it to 'élaborer et mettre en œuvre un système d'identification qui permet une traçabilité adéquate depuis la fabrication jusqu'à l'utilisation finale du dispositif médical' (devise and implement an identification system allowing adequate traceability from manufacture to final use of the device), alongside the fourth indent's duty to keep the technical documentation and the declaration of conformity for the product's life cycle. On the distribution side, the fourth indent of art. 35 requires distributors and manufacturer representatives to 'appliquer le système de traçabilité défini par la structure en charge de la Réglementation pharmaceutique ou à défaut celui du fabricant' (apply the traceability system defined by the regulation structure or, failing that, the manufacturer's). The device registration decision itself is a database event: under art. 39 the marketing of devices subject to homologation is sanctioned by a five year renewable marketing authorisation, and the list of devices subject to the homologation procedure is fixed by the regulation structure and must contain at least class B, C and D devices (art. 38). The UEMOA lignes directrices adopted in the decree's visas add a pre placement declaration step for each supply chain actor on the annexed 'FORMULAIRE RELATIF AUX DECLARATIONS ET A LA COMMUNICATION DE DISPOSITIFS MEDICAUX'.

Wholesalers must keep records on type, number/quantity of devices sold in Serbia and all imported and exported devices (per pack), containing device name and description, manufacturer and AR name/address, quantity, registration decision number or import approval number, lot or serial number, UDI or bar code where applicable, and the consignee. Based on these records, the wholesaler and the manufacturer/AR submit to ALIMS a turnover and consumption report for the previous calendar year by 15 April at the latest.

The UDI related provisions of the Law the Unique Device Identification definition (Art. 2 item 98), the importer verification of UDI/bar code (Art. 80(2)(6)), and the UDI/bar code entry in wholesale records (Art. 85(2)(8)) will be applied only as of the date of accession of the Republic of Serbia to the European Union.

The UDI on the label or on the device itself and on all higher levels of device packaging must be presented in both human readable interpretation (HRI) format and AIDC forms such as linear barcodes, two dimensional barcodes, QR codes, or RFID.

UDI compliance dates are 1 Nov 2022 for coronary stents, orthopaedic joint replacement implants and intraocular lenses; 1 Nov 2024 for Class D general devices and IVDs; 1 Nov 2026 for Class C; and 1 Nov 2028 for Class B. Class A may be implemented voluntarily. UDI is not required for clinical research, investigational testing, clinical trial, or custom made devices.

HSA publishes GN 36 R2 Guidance on the Medical Device UDI System (July 2022); UDI implementation requirements and submission of UDI information into the SMDR and Class A Medical Device Database were consulted in 2021, and from 14 July 2025 GN 21 change type 6E allows submission of UDI data elements for registered devices.

Upon national notification/registration ŠÚKL assigns national device codes (ŠÚKL kód), maintained in the ŠÚKL device database (VIS ZP). Codes are the reference needed for Ministry of Health categorization (reimbursement listing); they are not a marketing precondition. Code status can be checked the next working day in the public search database on sukl.sk; ŠÚKL does not issue extracts from the registered/notified device database. From 28 May 2026 device registration moves to EUDAMED (UDI/Devices module mandatory).

submissionSurface: EUDAMED shared layer plus JAZMP national registration and forms: device registration moves to the EUDAMED device module (transition ends 28 November 2026 per Commission Decision (EU) 2025/2371); until then RS seated manufacturers/ARs file Art. 45 national applications including the basic UDI DI, and interim importers keep UDI records for supplied devices · verifiedHighlights: JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free sale certificates.; The current national basis includes the Medical Devices Act ZMedPri 1.

A licence application must specify, as determined by the Council, the medical devices or IVDs (or group or family) to be manufactured, imported, exported or distributed and sold; the licensed product list is maintained through update notifications, and the device register (once registration is called up) records the registration number, class, holder, original manufacturer and nomenclature system code (GMDN based).

A permanent record of Class D implantable and high risk custom made devices sold to patients must be kept on the premises of the healthcare institution/professional (patient identity, device model/batch/serial, user, manufacturer) and retained by the seller for at least five years beyond the expected life of the device; manufacturers, distributors or wholesalers of Class D or implantable custom made devices must keep invoice records (date, product, purchaser, quantities, batch/serial) for fifty years from the date of sale.

MFDS may build and operate an electronic information system (의료기기통합정보시스템) that records and manages device information from approval through manufacture, import, distribution and use.

Manufacturers/importers (제조업자등) must register the medical device standard code (의료기기 표준코드, i.e. UDI) and device information prescribed by Prime Ministerial Decree into the integrated device information system; MFDS administrative rule 「의료기기 표준코드의 표시 및 관리요령」 (고시 제2023 67호) details marking and management.

submissionSurface: EUDAMED (UDI/device registration) plus national RECOPS commercialization registration from 15 June 2026 · verifiedHighlights: RECOPS requires the product to be notified and visible in EUDAMED and downloads product data from EUDAMED.; The RECOPS communication must include the UDI DI (product identifier) and the labelling and instructions for use used in Spain (RD 192/2023 art. 18.2).

NMRA publishes a public 'List of NMRA Registered Medical Devices' (current version valid as of 09/07/2026) on its medical devices hub.

Devices other than custom made and investigational devices carry a Unique Device Identification consisting of a UDI device identifier (UDI DI) specific to a manufacturer and a device and a UDI production identifier (UDI PI) identifying the unit of device production; the UDI is placed on the label of the device or on its packaging and is stored, together with the related device identifiers, by economic operators, health institutions and healthcare professionals under the conditions laid down in Art. 27.

IVD UDI affixing deadlines: Class D from 26 May 2023; Classes B and C from 26 May 2025; Class A from 26 May 2027.

The manufacturer (or system/procedure pack assembler) must assign a UDI to the product, system or procedure pack and all higher levels of packaging before placing on the market (custom made devices exempt) and affix it to the labelling; shipping containers are not higher packaging levels. Affixing deadlines: implantable devices and Class III from 26 May 2021; Classes IIa and IIb from 26 May 2023; Class I from 26 May 2025; reusable products requiring the UDI on the product itself: 2 years after the respective class date.

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 Market Authorization Holder must maintain records of supply and records of complaints for all medical devices and accessories they have registered or notified, individually or as part of a device group.

Labels must incorporate the information required for Unique Device Identification (UDI) purposes per the labelling guideline; UDI is defined as a unique numeric or alphanumeric code that allows clear and unambiguous identification of specific devices on the market and facilitates traceability.

UDI is not yet required in Thailand: the Thai FDA FAQ states that UDI is not currently in use and the implementation timeline is not yet fixed (readiness activities are ongoing).

The manufacturer's declaration of conformity filed in a Tunisian device dossier must state, as a minimum, the manufacturer's name and address and the product's trade name, product code and lot number, or any other unique reference allowing the device covered by the EU declaration of conformity to be identified and traced. The declaration must also state which legislation the device complies with (for example Regulation (EU) 2017/745), the place and date of issue and the signatory's name and full details, the standards (ISO, EN) to which the device is declared conform, the risk class of the device (I, Is, Im, IIa, IIb, III) and, where applicable, the notified body's name and identification number, a description of the conformity assessment procedure followed and the reference of the certificate(s) issued.

The manufacturer's declaration of conformity filed in a Tunisian device dossier must state the Basic Unique Device Identifier — « Identifiant Unique des Dispositifs de base (IUD ID) ». Where the products are identified by their Basic UDI, their correspondence must be shown if it is not already indicated on the declaration of conformity. The Basic UDI is thereby an entry on the device's filing document rather than a separate Tunisian UDI database record.

UDI carrier application dates: non reusable devices — implantable and class III from 26/5/2021, class IIa and IIb from 26/5/2023, class I from 26/5/2025; reusable devices that bear the UDI carrier on themselves — implantable and class III from 26/5/2023, class IIa and IIb from 26/5/2025, class I from 26/5/2027.

The UDI System (established and controlled by the Commission, defined in Annex VI Part C) enables identification of devices other than custom made and investigational devices and facilitates traceability; the Commission established and operated UDI database is used (Madde 28), and data entry into EUDAMED is performed by the relevant parties (Madde 33).

Device registration in UTS requires mandatory UDI fields, including the UDI issuing agency (UDI Tahsis Kuruluşu) and the UDI DI number; the authorized UDI issuing agencies are GS1, HIBCC, ICCBBA and IFA.

Uganda imposes label level device identification and manufacturer record keeping, not a UDI system. Reg. 29(1)(c) of S.I. 2014 No. 29 requires the label to carry 'the identifier of the surgical instrument, including the identifier of any surgical instrument or appliance that is part of a system, test kit or group', and DAR/GDL/028 s. 4.4.1(j) adds the batch number / lot number / identification number. INS/GDL/047 s. 6.4 requires each manufacturer to establish and maintain procedures for identifying components, manufacturing materials, intermediate products and finished products during all stages of storage, production, distribution and installation, and to identify each unit, batch or lot of products with a serial or batch number, recorded in the device history record. The traceability records NDA itself keeps are the register of surgical instruments and appliances maintained under reg. 26 in the Schedule 5 format, and it is to be available on the NDA website. No UDI rule, UDI issuing agency designation or UDI database was found in S.I. 2014 No. 29, DAR/GDL/028, INS/GDL/047 or on NDA's Medical Devices page.

The 2013 technical regulations contain no UDI requirement; Resolution 759/2026 introduces one: implementation plan items include creating the UDI system (December 2027), appointing UDI issuing organizations (December 2028) and a National Medical Devices Database of 7 electronic systems (registration of devices, UDI database, economic operator registration, designated bodies and certificates, clinical investigations, vigilance and post market surveillance, state market surveillance) due December 2029.

EDE must establish, in coordination with local health authorities, a national system for circulation, tracking and coding of medical products from the factory to the end user, used for reporting by health authorities, establishments, health professionals, customs and the public.

EDE records medical products granted marketing approval in the national Medical Products database established under Article 66. Article 66(2) leaves data sources, access and exchange procedures to a decision of the Board of Directors.

A field safety notice must identify the devices and include any unique device identifiers in a searchable format; the initial trend report to the Secretary of State must likewise contain device descriptions/UDIs and the number of devices placed on the market in Great Britain.

Reports of corrections and removals submitted under 21 CFR 806.10 must include the unique device identifier of each device involved (21 CFR 806.10(c)(5)).

PMA periodic reports must identify each device identifier (UDI DI) currently in use for the device and any device identifier that has been discontinued (21 CFR 814.84(b)(4)).

Products must bear the MSP product registration number and the responsible Director Técnico name on the label; distributors must exhibit the registration of the products they commercialise together with documentation on their suppliers and acquirers; on questioned product notifications the company must report units sold and buyers.

The Centre maintains the State Register of medicines and medical devices permitted in medical practice; it is published on the official websites of the Ministry of Health and the Centre and is open to everyone. Device entries show the device name (model, modification, version, format, size), country and manufacturer details with production site addresses, field of application, certificate number and date, change date, potential risk class and device nomenclature (where available).

The trilingual application form and the registration certificate include the device's Unique Device Identification (UDI) and Global Medical Device Nomenclature (GMDN) "if available"; the Regulation defines UDI as a unique code created under international standards to identify a device and track it in circulation.

Decree 98 makes traceability of medical devices (truy xuất nguồn gốc) one of the statutory management principles for devices.

statement: The device description required with a ZAMRA application must include the material of construction for the device and for packaging material where applicable, the device dimensions, and the GMDN code, lot number and UDI. ZAMRA also publishes a register of valid, expired and withdrawn marketing authorisations for allied substances, and a separate guideline on traceability of medicines exists but is not drafted for devices. No UDI issuing agency designation, UDI database or UDI submission obligation for devices was found in the ZAMRA device guidelines.

Under MCAZ's traceability guideline the brand owner or manufacturer must share the unique identifier data of a medical product with the Authority before placing it on the market, and supply chain stakeholders must electronically capture and share the unique identifier together with its associated traceability information (date, time and time zone of manufacture, receipt and distribution or dispensing; physical location; source received from; destination distributed to; GSRN and master data of handlers where available; logistics processing; disposition including in transit, expired, recalled, stolen, sold and dispensed; and any other information the Authority requires). Records of the linkage between products created, received, processed or dispatched must be kept for a minimum of one year after the expiry date of the product and transmitted to the Authority on request. Identified errors in the unique identifier data must be captured and shared with the Authority within 48 hours of becoming aware of them; where a data carrier cannot be scanned the manufacturer or supply chain stakeholder must inform the Authority within 48 hours before taking any further action; and stolen or lost medical products must be reported with their unique identifier within 24 hours.

MCAZ's traceability guideline applies to the traceability of medical products manufactured, imported, exported, advertised, sold, distributed or used in Zimbabwe. A medical product placed on that market must be identified with a unique identifier created and assigned by the brand owner, and that unique identifier must consist of the GTIN, the batch or lot number, the expiry date and the serial number at primary and secondary packaging level (GTIN, batch or lot number and expiry date at tertiary level). The unique identifier of the primary and secondary package must be encoded in a GS1 data matrix. The guideline admits only a closed list of exceptions, none of which is a general device carve out: pharmaceutical product imported for personal use, unregistered medical product imported with the Authority's approval, medical product for clinical trials, medical product for research purposes, extemporaneous preparations, and any other product approved by the Authority.