Label, IFU & language by country

Every device placed on the market and put into service must bear the label in the Albanian language, presented in visible and legible form; information made available to the user and patient per point 13 of Annex I of the technical rule must be in Albanian, whether the device is intended for professional or other use.

Labels must contain the manufacturer's name or trade name and address; for devices imported into Albania the label, outer packaging or instructions for use must also carry the name and address of the responsible person, the manufacturer's authorized representative established in Albania, or the importer in Albania.

Instructions for use (instruksione për përdorim) are not required for class I and class II devices.

The dossier must include a mock up of the primary and secondary packaging in clear, easily legible characters in Arabic and in any foreign language in use in Algeria, per annexe I of the 10 May 2021 arrêté; ANPP Note N°42 2026 of 11 May 2026 addresses conformity of mandatory packaging mentions for pharmaceutical products and devices.

The homologation decision carries the obligation to indicate on the labelling (étiquetage) and the instructions for use (notice d'instruction) all mentions essential for the protection of health; the decision itself states commercial name, designation, classification, characteristics, holder and operator names/addresses, manufacturers and manufacturing sites, storage conditions and duration, and certifying bodies.

For listed implants (cardiac and vascular circulatory implants, CNS implants, spinal implants, hip and knee prostheses, breast prostheses, intraocular lenses) an implant card must carry product name/model, lot or serial number, manufacturer and importer name/address, and ANMAT registration number, with blank fields for the implanting center, implantation date and patient ID; it is issued in triplicate (patient record, patient, financing entity).

Device labels must state, in Spanish, at least: manufacturer/importer name and address, product identification, the word 'estéril' where applicable, lot number or serial number, manufacture and expiry dates, single use indication where applicable, storage conditions, warnings/precautions, sterilization method where applicable, the responsible technical professional, and the ANMAT registration number.

label ifu: Spanish · submission: Spanish; foreign documents must be legalized/apostilled and translated by a public translator · status: verified official

Documents attached to the application in foreign languages (except Russian or English) must be submitted with an Armenian translation certified in the procedure established by Armenian legislation. Russian language and English language documents do not need translation.

Before sale, the importer must assess that the documents accompanying the medical device match the actual data of the device and that any special storage and transport conditions are complied with. For a registered medical device the importer must also verify the presence of the special circulation mark approved by EEC Council Decision No. 26 of 12 February 2016 and the conformity of the labelling with the requirements approved by EEC Council Decision No. 27 of 12 February 2016. For an unregistered medical device the importer must verify that the pack or the instructions for use carry the name, trade mark and contact details of the importer or of the manufacturer's official representative in Armenia. The importer must also ensure, before sale and under its own responsibility, that the storage and transport conditions of the device comply with the general safety and effectiveness requirements approved by EEC Council Decision No. 27 of 12 February 2016 and with the conditions established by the manufacturer.

Device information may be supplied in multiple languages, but if the device is supplied in Australia one of those languages must be English; information supplied with the device must be clear, legible and provided in English. Labelling content requirements are in Essential Principle 13 (Schedule 1, MD Regulations) and the sponsor's name and address must appear on supplied devices under Regulation 10.2.

On request of users or patients, the EU declaration of conformity (Art. 19 MDR / Art. 17 IVDR) and the declaration for custom made devices must be provided in German.

Field safety notifications for field safety corrective measures in Austria must be drawn up by the manufacturer in German and submitted to BASG together with the report form and the customer list (plus a timetable).

Devices may only be supplied to users or patients in Austria if the information supplied with the device (label and instructions for use) is drawn up in German; for devices whose use is reserved exclusively to professional users, the information may instead be in English.

The dossier must carry the manufacturer's labelling and packaging information, including colour mock ups of the packaging and labels and their content in the Azerbaijani language. The instructions for use of a medical device containing a medicinal substance must be supplied by the applicant as a notarially certified translation into Azerbaijani, checked by the Analytical Expertise Center and approved by the Ministry; the approved instructions of registered products are published in PDF on the Center's official website.

Bahraini labelling rules require the label text to be clear and in Arabic or English, so English only labelling is acceptable; Arabic is not mandatory. The label must carry the device name, manufacturer name and place, an identification number (catalogue, reference or model number), lot or serial number, date of manufacture, storage and handling conditions, sterile state and sterilisation method where applicable, warnings, single use status, presence of medicinal substances, human blood or plasma derivatives, or tissues of human or animal origin, and an indication that the device is a medical device.

Device packaging must be labeled per relevant International/ISO standards and GHTF guidance GHTF/SG1/N70:2011, with internationally accepted symbols (e.g. sterilization, single use) per ISO 15223 1:2007; labels must show date of manufacture or expiry (or both); imported devices may be further labeled by the importer under quarantine before release for sale; IFU/user manual (including e labeling) is part of the dossier.

The IFU (инструкция по применению) or operation manual (руководство по эксплуатации) and other foreign language dossier documents must be accompanied by a translation into Belarusian or Russian; the labeling/packaging sample must be provided in original color certified by the producer.

The EU declaration of conformity must be translated into one of the three national languages or into English.

The implant card and the information for the patient are provided in one of the three national languages or in English, at the choice of the patient or their representative.

Manufacturers must accompany devices made available to the user or patient on Belgian territory with the information required by MDR Annex I chapter III section 23 in the three national languages (Dutch, French, German); for devices used solely by health professionals, this information may be provided in English.

statement: Where the device or biomedical equipment carries operation, maintenance or installation manuals, they must contain sufficient information to ensure proper execution of the procedure and safe use, in Spanish. The manuals must accompany the device; in special cases the instructions for use may be given on the secondary packaging or in an operating manual, and for biomedical equipment the operation, maintenance and installation manuals form part of the technical scientific information. · article: Numeral 2.7

statement: Labels and package markings with wording in several languages are accepted provided one of them is Spanish. The minimum content is the product name, lot or serial number, expiry date where applicable, manufacturer name and special legends; the marketer identification is added under Article 149 of DS 25235. AGEMED accepts the Spanish use information and special legends being added by insert, adhesive sticker where applicable, or package insert, while the minimum content of numeral 2.5.1(c) must be printed. · article: Numeral 2.5.1(b) and (c)

The registration dossier for a class I, IIa, IIb or III device must contain the instructions for use in a foreign language for products of foreign origin together with a proposed instruction in one of the languages in official use in Bosnia and Herzegovina. The same requirement applies to in vitro diagnostic medical devices.

Instructions for use are exceptionally not required for class I and class IIa medical devices where those devices can be used safely without instructions. Instructions are also not required for medical devices handled by professional staff.

Every medical device marketed in Bosnia and Herzegovina must be marked as such on the outer and immediate packaging in one of the languages in official use in BiH and must have instructions for use enclosed. The instructions for use must be written in one of the official languages of Bosnia and Herzegovina in an understandable manner allowing proper and safe use, and under Pravilnik Član 55. stav (2) must contain the packaging particulars (except batch number and expiry), information on the device's action and possible adverse effects, its behaviour in combination with other devices, measures for effective and safe operation, calibration and maintenance, implantation information, interaction risks, instructions for damaged sterile packaging and re sterilisation, reprocessing procedures and limits for reusable devices, and radiation data for emitting devices. (Zakon 58/08 Član 113. stav (3) separately requires at least information on undesirable occurrences during use, a detailed description of installation and of checking correct use.)

BoMRA's labelling guideline requires that the product labelling of medical devices including IVDs be in English, and that all characters on labelling be of adequate size and legibly printed.

Information on labels and in instructions for use must be written in Portuguese.

Brunei's only product labelling instrument is the Medicines (Labelling) Regulations, made under s. 81(1) of the Medicines Act, whose rules cover dispensed medicinal products, clinical trial products, products containing Schedule 1 substances (which must carry a statement in English declaring the substance) and date stamping of Schedule 2 products. Sections 46 and 47 of the Act confine the labelling and leaflet rule making powers to medicinal products. No labelling, instructions for use or language requirement exists for medical devices or IVDs.

The instructions for use must also be drawn up in Bulgarian (national language requirement for devices placed on the market in Bulgaria).

An instructions for use document is not required for general medical devices of class I and IIa which, in the manufacturer's judgement, can be used safely without an IFU.

The labelling annex makes the product owner's name and contact details mandatory on the labelling, and requires the labelling of all devices to carry sufficient details to identify the device and, where not obvious, its intended purpose, user and patient population; a batch/lot number or serial number to allow trace and recall; a use by date expressed at least as year and month where relevant, with storage conditions and shelf life after first opening; the information needed to verify proper installation and safe operation including maintenance, quality control, consumable replacement and calibration; warnings, precautions, limitations or contra indications; the performance intended by the product owner and undesirable side effects where relevant; special storage or handling conditions on the external packaging; and any further treatment or handling needed before use. The inclusion of the manufacturing site and of the importer's, authorised representative's or physical manufacturer's contact information is optional. Internationally recognised symbols are encouraged, with an explanation where a symbol is not obvious to the user.

A medical device must be labelled in accordance with the requirements of the Member State before it is placed on that State's market. Member States may set labelling requirements by reference to Annex 7 or as they deem appropriate, and may require the label to be in their national languages. Cambodia is therefore permitted to impose a Khmer language label requirement but is not obliged to by the instrument.

The manufacturer of an implant must provide two implant registration cards with the implant (one to be kept by the patient and one returned), stating for example the implant's identifier and the date it was provided.

Labels and accompanying directions for use may be in either English or French (s.23(1)); the other official language must be provided as soon as possible at the purchaser's request (s.23(2)); both languages are required on the label where the device is sold to the general public for the items in s.21(1)(a) and (e) to (j), such as directions for use (s.23(3)). Regulatory submissions may be in either official language.

For professional use HIV IVDs intended for trained users, a label in English with international symbology is accepted provided the insert (IFU) is in Spanish. The instructions for use must be supplied in the Spanish version used for marketing in Chile (for imported products the English version is also submitted); for self tests, the prospectus must be provided to the user printed and in Spanish mandatorily; documents in a language other than Spanish require a simple translation under sworn declaration.

The device registration is identified by an alphanumeric code granted by ISP, which must be incorporated legibly on the label (rotulado) of the DM/DMDIV.

Devices subject to conformity verification must state, legibly on the product itself or its packaging, that they have been verified and the number assigned by ISP; where product nature/size makes this impossible, ISP may exempt or substitute the indication by resolution.

Imported devices must have a Chinese IFU and Chinese label; the IFU must state the country of origin and the name, address and contact details of the China legal person enterprise designated by the overseas registrant/holder. Devices without compliant Chinese labels may not be imported.

Labels and IFUs must use Chinese, conforming to national language norms; other languages may be added, but the Chinese text prevails.

Labeling must give information needed to identify and safely use the device, supplied on the device itself and/or packaging or accompanying material, in easily comprehensible terms; for imported devices the label, packaging or instructions for use must include the name and address of the importer in Colombia or the manufacturer's authorized representative.

Package labels must carry, at minimum, in Spanish: product name; lot or serial number; expiry date when applicable; registro sanitario or permiso number; manufacturer and/or importer with address; and special legends such as 'estéril', 'usar solo una vez'.

Per the official labeling guide, the complementary label must be placed on the smallest commercial package (the package the final consumer receives) and must be affixed before commercialization by the distributor inside the EMB storage warehouse; class 1 products, being exempt from registration, do not carry a registration number and may state on the label that they are exempt (exonerado de registro).

EMB labels must show: true specific product name; intended purpose/use; name or tradename/logo and country of the holder; name or tradename/logo and country of the manufacturer; product identification code (or declared model); lot number; package content description; expiry date or shelf life; 'sterile' indication when declared; special storage conditions; symbols and warnings where applicable; instructions for safe use (or reference to insert/manual); personal use indication; single use indication; 'producto a la medida' legend for custom made products; for personal use IVDs the legend that the self test is only orientative; EMB registration number (not applicable to exempt products); and for research only IVDs the corresponding exclusive research use legend.

EMB labeling must contain the required information in Spanish; if the original label is in another language, a complementary (supplementary) label translating the mandatory information is permitted, and it may also be used to add mandatory information missing from the original Spanish label; inserts and manuals accompanying the product as marketed must be in Spanish. Registration documents must be in Spanish (official translation for legal documents).

All documents of the device marketing authorisation application must be in French and presented in a box or binder bearing the product's trade name, the laboratory's name, the name of the representation agency and a telephone contact. Specifically, the summary of the device's characteristics and technical specifications must be in French, and the labelling model and the instructions for use model are filed with the application. In addition, three samples of the final sale model must be presented in French and have a validity of at least twelve months, accompanied by the certificates of analysis.

Under Article 30 of the implementing act, data and documentation used in the implementation of the MDR and IVDR that are intended for patients and laypersons must be in the Croatian language. Data and documentation intended for competent authorities, or exclusively for use in the performance of health care activity, may be in Croatian and/or English. Certificates issued by notified bodies must be at least in the Croatian language, and the competent authorities draw up procedural documentation in Croatian.

Registration evidence must include final artwork or a photo/sample of the primary container label, in Spanish or English, complying with the requirements of the regulations in force; Anexo 2 evidence 17 and the acápite 3.2.2 evidence list state the same for the primary packaging label.

Under Decree No. 6, made under article 59(1)(ζ) of the Cypriot Basic Requirements laws and published in the Official Gazette of the Republic of Cyprus No. 4462 of 5 January 2012, the information required for the safe and proper use of the product that accompanies each product must be provided in the English and/or Greek language. For products intended for use by non healthcare professionals, that information must necessarily also be provided in Greek.

In a notice of 24 March 2026 CYMDA restated the language requirement for medical devices and in vitro diagnostic products: under Decree No. 6, made under article 59(1)(ζ) of the Basic Requirements laws 2002 to 2011, the information required for safe and proper use must be provided in English and/or Greek; for products intended for use by non healthcare professionals it must necessarily also be provided in Greek; and instructions for use must meet the relevant requirements of Regulations (EU) 2017/745 and 2017/746. Importers, distributors, pharmacies, retail points of sale and companies making online sales are told that placing non compliant products on the market is prohibited, and that where non compliant products are identified CYMDA may impose administrative measures and/or fines under Law 225(I)/2022 on market surveillance.

A distributor distributing a device to the Czech market must supply the device including the instructions for use in Czech, where the manufacturer has issued an IFU.

A manufacturer placing devices on the Czech market must provide in Czech the information under MDR Art. 10(11) / IVDR Art. 10(10), the information under MDR Art. 18(1)(a) (d), the information under MDR Art. 89(8) / IVDR Art. 84(8), and the statement under MDR Annex XIII point 1.

A healthcare provider must not use a device when it does not have the instructions for use in Czech; this does not apply to class I and IIa devices and class A IVDs for which the manufacturer determined that an IFU is not necessary for safe use.

Labelling and instructions for use (brugsanvisning) for devices and IVDs must be in Danish when the device is made available to the final user or patient in Denmark. DKMA may exceptionally permit non Danish labelling/IFU where health considerations so indicate, but cannot permit it for IVDs for self testing or near patient testing as defined in IVDR Article 2(5) (6).

The Danish Medicines Agency may in individual cases order a manufacturer to translate an EU declaration of conformity into Danish when necessary for DKMA's market surveillance; non compliance with such an order is punishable by fine.

The implant card and the information accompanying an implantable device under MDR Article 18 must be in Danish when the device is made available in Denmark; DKMA may exceptionally permit another language where special health considerations so indicate. Danish health institutions must moreover hand over the implant card and the Article 18(1) information to patients who receive an implant (lov om medicinsk udstyr § 5c).

statement: Ley 42 01 Art. 112 requires the legends and texts of the labels of the products covered by Libro Cuarto (which includes the Art. 109(b) device families) to be written in Spanish, and imported products must carry a counter label in Spanish with all the required data. Labels, package inserts, leaflets, blisters and any other packaging material must be filed with the renewal as they are actually marketed, and where documents are in a language other than Spanish they must be translated by a judicial interpreter. The registration file requires a proposed insert or instruction leaflet and proposed primary and secondary packaging. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

The insert/manual of use must be drafted in Spanish (other languages may additionally be included), is part of the commercial presentation in printed form directed to the user, and is evaluated and approved as part of the registration dossier; minimum content for devices: commercial name, technical specifications, indications/use, mode of use, conservation and presentations; IVD inserts must additionally cover methodology, principle, performance criteria and limitations, specimen, procedure, quality control and precautions.

Labels of primary and secondary packaging of imported and national devices must be in Spanish or English, clearly legible and indelible, and contain at least: commercial name, container content, indications for use, precautions/warnings, storage conditions, manufacturer name city country, manufacturing sites, expiry/shelf life when applicable, storage temperature, batch/serial number, registration number and required legends (e.g. 'sterile', 'disposable'). Biomedical equipment is excluded from this list and must be marked per IEC 60601/80601/ISO 80601 (minimum: batch/serial, manufacturer name, brand). Reduced primary packaging labeling (registration number, name, manufacturer, expiry, lot) is allowed where nature prevents full labeling and the secondary label carries everything.

Electronic labeling is accepted: the foreign manufacturer's e IFU is submitted in the registration file and attached to the registration license, with artwork approved by the legal manufacturer carrying the statement that a printed paper IFU will be provided at the latest within 7 calendar days of a user request.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

Minimum label data: trade name, product name, product code/model/Ref, batch or serial number, special handling and storage precautions, single use indication where applicable, expiry date (month/year at least), UDI on label or packaging when applied, factory name/address and country of origin, sterilization word/symbol plus method, and the Egyptian importing company's full name and address as recorded in the importers registry.

Because Egypt falls in climate zone IVa, local manufacturers must run stability studies at 30 C +/ 2 and RH 65+/ 5%, and place a guiding symbol on internal labels stating the maximum storage temperature is 30 C, or clearly state 'Upper limit of temperature = 30' on the label; storage under the labeled conditions is followed up by inspection.

The EU declaration of conformity of a device distributed in Estonia must be drawn up in Estonian or English, or translated into Estonian or English; a notified body registered in Estonia issues its conformity certificates in Estonian or English.

Information accompanying a device placed on the market, made available, distributed or put into service in Estonia must be presented: in Estonian, in an appropriate manner, where the device is intended for lay users; in Estonian or English where the device is intended only for professional users; and in a language understandable to the specific user for a custom made device. Other information accompanying the device may be in another EU or EEA Member State language understandable to potential users.

All medical device labelling must be in English and/or Amharic, and labels must be legible, indelible and not easily detachable; any product information on the labelling must be based on scientific justification (EFDA/GDL/084 §3.1). Label content is prescribed in GDL/084 §3.4: for the device itself, device name, batch/lot or model and serial number, manufacturing and/or expiry date, manufacturer/licence holder name and address, country of origin, technical details and warnings; for the package label, additionally intended use, storage conditions and net quantity. Separately, for low risk devices filed under GDL/092, §5.1.5 requires all label statements in English or Amharic, product information that does not vary significantly from claims made in other jurisdictions, and (where applicable) a unique identification/device code, an associated barcode and the CE mark on the item or primary packaging for CE marked devices; brochures or manuals for instructions for use and assembly must be in English or Amharic.

The label must bear all Annex I Section 23.2 MDR particulars, including: name/trade name of the device; details necessary to identify device, packaging contents and intended purpose; manufacturer name and registered place of business; for non EU manufacturers, the authorised representative's name and address; lot or serial number; the UDI carrier; and where applicable indications of content of medicinal substance or tissues/cells of human or animal origin.

Devices must be accompanied by the Annex I Section 23 information in an official Union language or languages determined by the Member State in which the device is made available to the user or patient; label particulars must be indelible, easily legible and clearly comprehensible (Art. 10(11) MDR). The EU declaration of conformity must likewise be translated into the official Union language(s) required by the Member State(s) (Art. 19(1)). The Commission publishes an overview of member state language requirements.

Where safety so requires, Fimea may order the manufacturer and authorised representative to supply free of charge, in Finnish or Swedish, the information and documents referred to in MDR Art. 10(14) and 11(3) second sub paragraph (d) / IVDR Art. 10(13) and 11(3) second sub paragraph (d), or defined parts of them.

If the device is intended for use by patients or otherwise by consumers, the instructions for use and other information required for safe use must be in Finnish and Swedish.

Information supplied to the patient under MDR Art. 18(1) first sub paragraph (implant card information) must be in Finnish, Swedish and English.

Information and documents under MDR Art. 10(11)/IVDR Art. 10(10) must be in Finnish, Swedish or English unless given as internationally recognised symbols; however, information required for the safe use of the device must be in Finnish and Swedish, with the manufacturer determining from risk analysis which information is safety critical. For custom made devices, IFU and markings must be in Finnish or Swedish or both, according to user needs.

The following must be drawn up in French: (1) labelling delivered to the end user or patient with the accompanying instructions for use and any other information on operation or use required by Annex I section 23 MDR; (2) patient information accompanying an implantable device and the implant card (MDR Art. 18); (3) the EU declaration of conformity (MDR Art. 19), stating the name/trade denomination used in France; (4) the safety notice under MDR Art. 89(8).

The administrative part of the registration dossier must include a standard packaging with standard labelling (or an electronic version) of the product to be registered, and, for an imported product, an authorised (attested) translation of the patient information leaflet into Georgian together with the original leaflet; for a product manufactured in Georgia a Georgian language patient information leaflet is required. The translated leaflet must cover both personnel with medical and pharmaceutical education and customers where differential versions exist; the procedures are set by the Ministry.

The EU declaration of conformity (MDR Art. 19(1) / IVDR Art. 17(1)) must be made available in German or English for products placed on the market within the scope of the MPDG.

Products may only be supplied to users and patients in Germany if the information intended for them is made available in German; in justified cases the information may instead be in English or another language easily understood by the user, provided it is intended exclusively for professional users and the safety related information is also available in German or in the user's language.

The manufacturer of an implantable product must make the information for the patient referred to in MDR Art. 18(1) (implant card and information) available in German.

Device labelling must be in English, legible, permanent and prominent, and must include: proprietary and common name, manufacturer name and address, manufacturing site, device identifier, control number for Class III/IV devices (otherwise batch/lot number), contents indication, 'Sterile' and 'for single use only' where applicable, expiry date, intended uses, directions for use, warnings, precautions and special storage conditions.

EOF Circular 37580/31.03.2025 accepts the use of the ENGLISH language in the Instructions for Use/user manual, the labelling and the software of medical devices placed on the Greek market, provided the devices are professional use devices according to their intended use as determined by the manufacturer and are used strictly and exclusively by healthcare professionals; where an exemption from Greek is granted the information must be in English. EOF and/or the user retains the right to require the information in Greek at any time, and hospital procurement requirements are unaffected.

Before devices are placed in circulation on the Greek market, the labelling and the instructions for use must be complete and accurate in the Greek language at delivery to the final user; under EOF Circular 37580/31.03.2025 this applies to all devices delivered to users or patients in Greece, professional or other use.

Secondary packaging of a medical device must carry the mode of use or instructions for use and the warnings; for imported products that information must appear in Spanish. The same rule applies to IVD labelling. Documents in a language other than Spanish must be translated by a sworn translator authorised in Guatemala.

Manufacturer and LRP contact details on labels must be in both English and Chinese wherever applicable; instructions for use (e.g. user manuals) must be in both Chinese and English, and if only one language is available this must be stated per the Special Listing Information requirements; other labelling should preferably be bilingual and at least in one of the two languages.

Listed devices must carry Special Listing Information: the device's Listing Number plus a supplementary statement if the IFU is available in only one language, and LRP name/address/contact in English and Chinese; the LRP has a six month grace period after listing to comply.

The information specified in MDR Annex I point 23 and the implant card per MDR Article 18 must be available to the end user in Hungarian.

Implant cards that health institutions give to patients are as a rule to be in Icelandic. Where that is not possible, the cards may be in English or another Nordic language other than Finnish. The same language requirements apply to the implant information that the manufacturer must publish on its website under Article 18 of Regulation (EU) 2017/745.

Information and instructions for use accompanying medical devices intended for use by the general public must be in Icelandic. However, for a device in risk class I or IIa, the instructions for use may instead be in English or in a Nordic language other than Finnish. Lyfjastofnun may publish on its website a list of types or classes of devices in risk classes IIb and III that are exempt from the Icelandic requirement. Importers must verify that the device is accompanied by the required instructions for use before it is offered on the market.

For devices intended for use by professionals, the instructions for use may be in English or in a Nordic language other than Finnish. For devices for lay use the general rule is Icelandic, with class I and IIa permitted in English or a Nordic language other than Finnish; for classes IIb and III Lyfjastofnun may exempt devices by publishing a list, and that list is exhaustive (currently covering condoms in classes IIb and III, last revised 18 November 2022).

Electronic instructions for use are expressly recognised: G.S.R. 30(E) inserted 'or electronic instructions for use' into rule 3(v), rule 59(3)(iii) and the Fourth and Seventh Schedules.

Labels must bear the device name, net quantity, month/year of manufacture and expiry (or shelf life), lot/batch number, storage conditions, sterile state and sterilisation method, single use indication where relevant, and warnings; imported devices add, by stickering where not printed, the import licence number, importer name and address, manufacturing premises address and date of manufacture; BIS or ISO symbols may replace text.

Shelf life ordinarily must not exceed sixty months from manufacture; imported devices must retain at least 40% residual shelf life (claims under 90 days), 50% (claims of 90 days to one year) or 60% (claims over one year) at the date of import.

Intended use/purpose, instructions for use, contraindications, cautions and warnings on device labelling and information must be in Bahasa Indonesia; languages other than Indonesian are permitted only where no Indonesian equivalent exists or can be created, or for goods traded abroad.

Device/IVD labels and information must state at least: trade name/brand; izin edar number; product type; manufacturer name and address; name and address of the authorization holder PAK; batch/production code/serial number; the word 'steril' and sterilization method for sterile products; product specifications; intended use and instructions for use; expiry date where applicable; and for certain devices that must be used by competent professionals the warning 'Hanya Boleh Digunakan oleh Tenaga Profesional' or the letter 'P' in white on black background.

Devices carry the tracking/authenticity label under the 'بخشنامه برچسب اصالت' published on imed.ir (path: imed.ir > ادارات > نظارت و ارزیابی (بازرسی) > اصالت کالا); label executors connect to the central system per Annex 3 protocol, and companies submit XML tracking label files through the system (pre payment steps require the CEO level account).

For research use laboratory items, the company must print 'فقط برای مصارف پژوهشی و تحقیقاتی' or 'Research Use Only' clearly and visibly on the label and brochure.

Under Iraq's Ministry of Planning standard bidding document for the purchase of medical appliances, the supplier's marking and documentation duties on the goods are set by the contract itself, not by a fixed national label content rule: the packing, marking and documentation within and outside the packages must comply strictly with such special requirements as shall be expressly provided for in the Contract, including additional requirements, if any, specified in the Special Conditions of Contract (SCC) or the Technical Specifications, and in any subsequent instructions ordered by the Purchaser.

An Irish health institution that implants an implantable device must give the patient the MDR Article 18(1) information and the implant card bearing the patient's identity as soon as possible, and no later than 30 working days after implantation.

For devices intended also for the home (non professional) user, the application must include the leaflet, a scanned packaging sample and user instructions in Hebrew and Arabic, compared against the approved (English) source approved by the foreign authorities; additional languages are permitted; translation must be done by external translation companies with a certification document from them.

The manufacturer must provide the safety notice (avviso di sicurezza) to the Ministry of Health in Italian; the Ministry assesses risks from reports received and the proposed safety notice and may require adjustments at the manufacturer's expense.

All information and indications for any type of IVD supplied in writing by the manufacturer to the user and the patient pursuant to IVDR Annex I (paragrafo 20) must be expressed in Italian at the time of delivery to the final user, for professional use or any other use.

All information and indications for any type of medical device supplied in writing by the manufacturer to the user and the patient pursuant to MDR Annex I Chapter III (paragrafo 23) must be expressed in Italian at the time of delivery to the final user, for professional use or any other use.

The manufacturer must supply with the implantable device the implant card and the information required by MDR Art. 18, which must be drawn up in Italian and in English; health institutions must make the information available to the implanted patient by the most suitable means (Art. 8(2)).

On Ministry request, the manufacturer (or authorised representative) must make available the information and documentation necessary to demonstrate device conformity — including audit, evaluation and inspection reports on MDR Art. 52 procedures — in Italian.

When marketing, the MAH must publish current precautions/safety information (注意事項等情報), based on the latest literature and other knowledge, by electronic/ICT means — the statutory basis of the electronic package insert (電子添文) system.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and prescribed precautions for designated devices.

Under Jordan's device testing regulation the 'sample' (العينة) that is submitted for examination and against which conformity is judged is defined as the final product of any medical supply, steriliser, disinfectant or cosmetic preparation, expressly including the inner and outer packaging and the leaflet accompanying it. The leaflet (النشرة) and both packaging layers are therefore regulated elements of the product, not marketing material. Where a sample fails to satisfy the specifications stated in the technical file as regards the secondary packaging materials — the inner and outer packaging, the leaflet accompanying it and other specifications — or where the laboratory report records an observation (ملاحظة) on the sample, the Director General decides what to do with it on the recommendation of the committee, notwithstanding that the sample passed the test.

For EAEU registration the operational document/IFU, service manual and device marking text are additionally submitted in the state language(s) of the member states where circulation is planned.

Devices must be placed into circulation with marking applied directly on the device and/or packaging and with an instruction for medical use or operational document in Kazakh and Russian, conforming to the Law «On Languages».

For the registration dossier it is sufficient to show labelling information in English only, but items to be translated and the translation plan should be indicated; legible versions of all levels of labels (primary and secondary packaging) representative of the finished form and showing all symbols must be provided, including labels, IFU, patient implant cards, surgical manuals and brochures.

statement: Information for users and patients under Annex I section 23 of Regulation (EU) 2017/745 must be provided in the Latvian state language. That information and other device documentation may be in another language only where the device is intended for use solely in a healthcare institution and only by correspondingly qualified and trained healthcare persons, with the consent of that healthcare institution to the language used. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

statement: Information for users and patients under Annex I section 20 of Regulation (EU) 2017/746 must be provided in the Latvian state language. It and other IVD documentation may be in another language only where the IVD is intended for use solely in a healthcare institution by correspondingly qualified and trained healthcare persons, with that institution's consent. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

The label affixed to the packaging must show the country of origin and the manufacturer's name and address in Arabic, English or French, and must carry: the manufacturer's name or business name and address; the indications strictly necessary for the user to identify the device and the contents of the packaging; where applicable the word "sterile"; where applicable the lot code preceded by the word "lot" or the serial number; where applicable the date until which the device can be safely used, expressed as year and month; where applicable an indication that the device is for single use; for a custom made device the words "custom made device"; for a device intended for clinical investigations the words "exclusively for clinical investigations"; particular storage and/or handling conditions; particular instructions for use; warnings and/or precautions to be taken; the year and month of manufacture for active devices not covered by the expiry indication; and where applicable the sterilisation method.

Product information may be in English instead of German if: the product is supplied exclusively to professionals or is a custom made or health institution manufactured product; the user is assured to have the necessary professional and language skills and agrees to English; protection of patients, users and third parties is ensured; and effective, performance related use is not jeopardised.

The field safety notice per MDR Art. 89(8) and the general overview of the clinical investigation per MDR Annex XV Chapter II No. 3.1.5 must be in German.

IVD labelling and instructions for use per IVDR Art. 10(10) must be in German; symbols concretised by technical standards may replace verbal statements. English is possible instead of German under conditions parallel to the device rule (professional only supply or health institution products, assured user skills and consent, protection of patients/users/third parties, no risk to effective use); the field safety notice per IVDR Art. 84(8) must be German (EWR IvDV Art. 11(1) (3)).

Labelling and instructions for use (product information) per MDR Art. 10(11) must be in German in Liechtenstein; symbols concretised by technical standards may replace verbal statements.

The implant card per MDR Art. 18(1) must be in German. Health institutions enter the identity data of the implanted person into the implant card, hand it to that person, and make the required information available to them in a quickly accessible form.

For IVDs for self testing or near patient testing per IVDR Art. 10(10), the product information must be easy to understand and in German.

Manufacturers (or their authorised representatives) must provide users and consumers with field safety notices prepared in the Lithuanian state language, in the manner established by Regulation (EU) 2017/745.

Information on the proper use and maintenance of a device, referred to in Regulation (EU) 2017/745 or 2017/746, must be attached in the Lithuanian state language, or in English where the information is intended only for healthcare professionals and the healthcare institution to which the device is supplied consents.

For active implantable medical devices, the information to be provided to users and patients must be written in French or German.

For medical devices and IVDs, the information to be provided to users and patients must be written in French, German or Luxembourgish. For devices intended exclusively for professional use, the information may also be provided in English.

Device labels must carry 13 items: name; model/specification; expiry date (or production date and shelf life); batch/factory number; manufacturer or holder name; origin; performance/main structure/ingredients/intended use; registration or filing number at origin or marketing country; contraindications and warnings; installation/use instructions; maintenance, transport and storage conditions; special safe use instructions; possible adverse events or side effect causing components. Items not on the label must be in the IFU. Class I and II devices need no IFU if they can be used safely for their intended purpose without one.

Labels and instructions for use must be written in at least Chinese, Portuguese or English.

Electronic IFU (e IFU) is eligible for devices intended for professional users; for home use devices it depends on a documented risk analysis; users must always be able to obtain a paper copy on request at no additional cost, the web address must be printed on the physical label, and e label content must be identical to the approved printed IFU.

Labels must not state or imply that marketing or use of the device is encouraged or endorsed by the Authority or Ministry of Health (fine up to RM10,000 and/or 3 months); labels must be clear, indelible and legible; the Sixth Schedule requires device identification (name, model, lot/serial, manufacture and expiry dates), manufacturer details and, for foreign made devices, the authorised representative's name, address and contact number.

Bahasa Malaysia is required for home use medical devices; English shall be used on labelling for other device types, and other languages may be used as necessary; where Bahasa Malaysia information is provided it shall appear on the label itself.

Medical devices and all accompanying information placed on the Maltese market must be in one of the national languages of Malta — English and Maltese, or both. The Authority states the requirement twice: that devices and all accompanying information must be in one of the national languages of Malta, English and Maltese or both, and that labelling of medical devices must be in English or Maltese to be placed on the Maltese market. Because English is an official language of Malta, an English only label satisfies the national language duty.

Any relabelling or repackaging of a medical device within the meaning of Article 16(2) of the MDR must be communicated to the manufacturer and to the Malta Medicines Authority at least 28 days before the relabelled or repackaged device is made available on the market. Within the same 28 days the distributor or importer must submit to the Authority a certificate issued by a notified body designated for that type of device, demonstrating that its quality management system complies with the Article 16(2) requirements. On request, a sample or mock up of the relabelled or repackaged device, including any translated label and instructions for use, must be made available to the manufacturer and to the Authority.

NOM 137 SSA1 2025 (device labeling) repeals NOM 137 SSA1 2008 and enters into force 360 natural days after its DOF publication; devices whose labeling cannot be modified in time have 180 natural days from entry into force to exhaust existing packaging materials and finished product stock.

label ifu: Sanitary information on labels and IFUs must be expressed in Spanish (NOM 137 SSA1 2025 point 5.1); other languages may be added at equal typographic size without contradicting the Spanish text (5.7); only the distinctive name/brand may appear in another language (5.10.2); imports may carry an added Spanish counter label applied after customs clearance (5.7.1). · submission: Registration dossier includes the Spanish label draft and Spanish IFU/operation manual (RIS Art. 179 II III); application documents in Spanish or English (RIS Art. 153).

For the CE track dossier the declaration of conformity issued by the manufacturer must be in Romanian or English. The device name is entered in the register in Romanian, preserving in their original form the trade names, marks, product codes, acronyms and other identification elements assigned by the manufacturer, and the remaining fields are completed in accordance with the declaration of conformity.

Where the applicant files labels and instructions for use, the Procedure prescribes the file names: the primary, secondary and collective labels as "Etichetă primară.pdf", "Etichetă secundară.pdf" and "Etichetă colectivă.pdf", and the instructions for use as "Instructiune de utilizare RO.pdf" or "Instructiune de utilizare EN.pdf". These documents are not part of the mandatory set: they may be filed on the applicant's initiative or at AMDM's reasoned request during the examination.

The instructions for use of laboratory diagnostic devices must be in Mongolian and contain the prescribed information. The instructions for use of medical equipment must also be in Mongolian. The medical equipment user manual must be in Mongolian or English. Medical device labels and markings must be written in either Mongolian or English.

statement: The instructions for use of a medical device must be written in the Montenegrin language and in the languages in official use in Montenegro, in line with the registration, and must correspond in full to the original manufacturer's text and be prepared so as to be understandable to the patient and user. The registration dossier must contain the original English language instructions for use issued by the manufacturer and a translation into Montenegrin confirmed by a medical doctor or dentist of the appropriate specialty. · languageRequirement: Montenegrin + languages in official use in Montenegro

statement: The outer and inner packaging of a medical device for professional use must be labelled in Montenegrin and in the languages in official use in Montenegro; exceptionally the outer packaging of a professional use device may be labelled in English with a label containing all the information on the original packaging. The outer packaging of a device the patient uses independently must be labelled in Montenegrin and the official use languages, or may carry a label containing all the information on the original packaging. The name of the manufacturer or its authorised representative and the number of the device registration decision must appear on the outer packaging, and may be on a label affixed to the outer packaging; affixing that label is not considered part of the manufacturing process. · languageRequirement: Montenegrin + languages in official use in Montenegro (English permitted for professional use outer packaging with a full content label)

Point 13.3 of the essential requirements lists the mandatory label indications. Item a) requires the name or company name and address of the manufacturing establishment and, for medical devices imported for distribution, that the labelling, the outer packaging and/or the instructions for use additionally contain the name and address of the importing establishment and the number and date of the registration certificate, as the case may be. The other items are: the indications strictly necessary to identify the device and the package contents; 'STÉRILE' where applicable; lot code preceded by 'LOT' or serial number; the use by date expressed by year and month; single use indication; 'dispositif sur mesure'; 'exclusivement pour investigations cliniques'; special storage/handling conditions; special instructions for use; warnings and precautions; year of manufacture for active devices not covered by the use by date; and the sterilisation method.

Under point 13.1 each device must be accompanied by the information needed to use it safely and identify the manufacturer, taking account of users' training; the package of each device must contain an instruction notice, with an exception for class I and IIA devices if they can be used safely without such instructions. Under point 13.2 the information should where appropriate take the form of symbols, and any symbol or identification colour must conform to the harmonised standards; where no standard exists, symbols and colours must be described in the documentation supplied with the device.

Point 14 of the essential requirements (annex II to arrêté 2856 15) fixes the languages of the instruction notice and the labelling of medical devices: for locally manufactured products, French and Arabic at minimum; for imported products for professional use, English and/or French and/or Arabic at minimum; for imported products intended for the general public, French and/or Arabic at minimum.

Complete labeling information must be included in the dossier for import recommendation applications at all classes (A, B, C/D).

The information to be supplied by the manufacturer and the general summary (as required by the MDR/IVDR) must be drawn up in Dutch.

By way of exception, the information may be drawn up in English if the device is intended to be used exclusively by a healthcare professional, on the condition that that professional has an adequate command of English.

The information, documentation and field safety notice (e.g. under MDR art. 10(14) and art. 89(8)) must be drawn up in Dutch or English.

Medicines Regulations 1984 reg 12(4): no person may sell a medical device that does not bear the name of the manufacturer, or the name of the manufacturer's distributor in New Zealand.

There are no specific legislative or regulatory requirements for medical device IFUs under the Medicines Act 1981 or Medicines Regulations 1984; Medsafe recommends following international best practice (GHTF/SG1/N43:2005) when preparing IFUs. Electronic IFU may be supplied in New Zealand if the sponsor can provide a hardcopy on user request.

The Instructions for Use must minimally include: description of intended use (what is measured/detected, function, disorder/condition of interest, automation, reported result type, specimen type and source, target population); test principles; description of reagents/calibrators/controls; materials provided and required; in use stability; specimen collection/shipping/handling conditions; traceability of calibrator and trueness control values; assay procedure and interpretation; analytical performance characteristics; clinical performance characteristics where relevant; reference intervals; interfering substances/limitations; and references where relevant.

All imported and locally manufactured devices must bear minimum label information: device name; manufacturer name and address; device identifier; group/family where applicable; batch or lot number; contents description; the word 'sterile' if sold sterile; 'for single use only' where applicable; manufacturing and expiry date (month/year) where applicable; directions for use unless not required; and special storage conditions. If the package is too small, the directions for use must accompany the device but need not appear on the outside of the package.

Medical devices in circulation must be marked in accordance with the Law on the outer and contact packaging in the Macedonian language and its Cyrillic script, and must contain instructions for use written in the Macedonian language and its Cyrillic script. The minimum label content is fixed by the Law: manufacturer and importer details, identification data, the marks for sterile, custom made, for clinical investigation and single use devices, the identification code, expiry date, storage conditions, special conditions of use, warnings, and the intended purpose together with other information relevant to public health. A parallel imported device additionally requires a supplementary Macedonian Cyrillic package label.

The Law enumerates the information that must appear on a device label: the name and address of the manufacturer and of the importer, the identification data of the device, the marks for sterile devices, custom made devices, devices intended for clinical investigation and single use devices, the identification code, the expiry date, storage conditions, special conditions of use, warnings and precautions, and the intended purpose together with any other information relevant to public health. The identification code is required by the label article itself; no UDI DI or EUDAMED entry is created by this provision.

Information given to patients with implantable devices that is to accompany an implant card must be provided in Norwegian.

Direktoratet for medisinske produkter may exempt a device from the Norwegian language requirement for labels/IFU where safe and correct use is ensured; exemptions are not granted on a general basis or for an unlimited period.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

Manufacturers may supply IFU electronically instead of paper for devices marketed in Oman intended for professional use, subject to: physical label indicating e IFU and how to access it (URL), e IFU identical to the paper version, paper IFU provided on request without undue delay or cost, prior versions kept on the website, availability retained 15 years after last manufacture (no expiry date/implantables) or at least 2 years after expiry date for other devices.

e IFU language should be available in Arabic and English; storage requirements additionally require all products to include labelling in English or Arabic if intended for home use.

Under rule 44, an instruction for use shall contain details on any contra indications, warnings and precautions, including precautions on performance changes or malfunction, exposure to environmental conditions (magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature, humidity), and an indication where drugs or medicinal products are incorporated into the device as an integral part.

Under rule 42, the label of a medical device must contain (a) details enabling identification — name, model if any, lot or batch or serial number, enlistment or registration number, date of manufacturing, date of expiry and the maximum retail price (MRP) fixed by the manufacturer; and (b) the name and complete address of the manufacturer, his licence number, and for devices manufactured outside Pakistan also the name and complete address of the importer or authorized representative.

Under rule 41, the language used for labelling of medical devices shall be English; however, the use of Urdu language shall be required for home used medical devices.

Pending draft reglamento (NOT in force): instructions for use and package inserts must carry a minimum content list — generic name or trade name; manufacturer name and address; intended use or indication; contraindications and expected side effects; identification of any incorporated drug and/or material of biological origin; any applicable storage or preservation requirement; and, for reusable devices, the appropriate reprocessing information (cleaning, disinfection, packaging and sterilisation method) as indicated by the legal manufacturer. The IFU or insert may be printed or electronic in two or more languages provided one of them is Spanish, and the use of international symbology is accepted.

Pending draft reglamento (NOT in force): for in vitro diagnostic devices of Classes B, C and D the factory insert, as it will be marketed in the country, must be filed and, where it is in a language other than Spanish, must be translated by a public translator authorised in the Republic of Panama. IVD labels are accepted in English or Spanish; internationally recognised symbols and colours may be used provided their descriptive text is clarified in the IFU or insert; for self testing (autoaplicadas) assays the printed label information is accepted in two or more languages provided one is Spanish; warnings and precautions must be evidenced. Re labelling or over labelling of any packaging is not accepted.

Pending draft reglamento (NOT in force): labels may use internationally recognised symbols, abbreviations and colours and must be printed, legible and resistant on both primary and secondary packaging. Labels are accepted in two or more languages provided one of them is Spanish; a label in a language other than Spanish is accepted only if the Spanish information is delivered separately by means of a complementary safety label. Re labelling or over labelling is NOT accepted on any packaging for use in the Republic of Panama. Electronic labelling must contain a means giving the user easy access to the label information (same program, web address or other means).

Pending draft reglamento (NOT in force): primary packaging labels, printed or electronic, must state the device name; brand and catalogue or model number as it will be marketed in Panama; manufacturer name and address; date of manufacture; country of origin or provenance or an internationally recognised abbreviation; indications and contraindications of use where applicable; lot number; expiry date or shelf life; quantity or volume contained where applicable; adequate storage and preservation conditions where applicable; sterility information where the device is sterile; and a 'single use device' statement, similar phrase or symbol where applicable. For the Certificado de Registro Sanitario application, electronic labelling must be submitted in printed form.

Every product must include on the label, labelling or in its instructions for use the legend instructing that a suspected incident or adverse event attributable to the medical device be reported by completing the notification form available at the DINAVISA tecnovigilancia page and sent to the tecnovigilancia@dinavisa.gov.py address.

The labelling and instructions for use filed with an imported device application must be translated into the Spanish language, and the same requirement appears in the label article as the duty to put mandatory information in Spanish or on a complementary Spanish label.

The information on the label of a medical device must be written in Spanish. Where mandatory information is not in the official language, it must be added on a complementary Spanish language label. If a specific technical regulation requires complementary information because of the product's specificity, it is added to the label or to the instructions for use as applicable. The resolution lists fourteen label requirements, beginning with the trade name, brand, legal name and address of manufacturer, importer and distributor, the name of the responsible technician, the DINAVISA authorisation legend and the authorised sale condition.

Labeling of immediate and secondary packaging and instructions for use of medical devices must be expressed in Spanish, printed indelibly, legibly and visibly; other languages are additionally allowed provided the information matches what is registered; all devices must include instructions for use in their packaging except where exceptionally permitted, and IFU/manual content follows Art. 140.

Applications must include clear colored pictures of the label from all sides of the packaging (loose labels or artworks of all layers) and package insert/brochure; lot/batch/serial numbers must be reflected; additional product claims on the label need supporting studies; CE marking on labels requires a valid supporting certificate; instruction for use must be detailed enough to guide users.

Product labels of devices with issued CMDR or CMDN must carry, prior to sale and distribution: (a) name and address of the importer; (b) name and address of the distributor (if exclusive distributor); (c) the CMDN or CMDR number.

Devices, systems and procedure packs intended for lay users must carry labels, instructions for use and a user interface in Polish, or expressed through harmonised symbols or recognisable codes, with the EU declaration of conformity (or Art. 22 statements) in Polish or translated into Polish. An English user interface is allowed only if all terms, symbols and commands are explained in the IFU or accompanying document, it poses no risk to the user and this is visibly marked on the sales packaging — never for devices intended for use in life or health threatening emergencies. Voice controlled devices must use Polish commands.

Devices intended for professional users must carry the EU declaration of conformity (or Art. 22 statements), labels and IFU in Polish or English; information addressed to the patient must be in Polish or expressed via harmonised symbols or recognisable codes; the patient facing part of a user interface must follow the lay user rules.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

Labelling, instructions for use, advertising material, implant card and other manufacturer information (including graphic interfaces) must be in Portuguese, without prejudice to including other languages, unless INFARMED waives Portuguese for specific device or user groups.

The information may, for justified reasons, be supplied in English for devices intended exclusively for healthcare professionals, only with their written consent and based on an ANMDMR approval (aviz).

The exemption from Romanian translation is granted for a determined period only, in exceptional well justified cases when no similar product exists on the market; ANMDMR validates or rejects the exemption request within maximum 30 days of registration, and the distributor/manufacturer must ensure training of the consenting professional receiving English language information.

Health institutions must provide implanted patient information under MDR art. 18(1) together with the implant card, in Romanian and understandable by a lay person; excluded for sutures, staples, dental filling materials, braces, crowns, screws, wedges, wires, needles, clamps and connectors.

Information supplied by the manufacturer with the medical device (MDR Annex I Chapter III point 23) must be presented mandatorily in Romanian, without excluding presentation in other official EU languages.

The user interface of equipment for healthcare professionals may, for justified reasons, be in English with the user's written consent; for equipment intended for lay users the interface must be in Romanian. For IVD self tests the interface must be in Romanian.

The dossier must include the manufacturer's operating documentation (эксплуатационная документация) for the device, including the instructions for use (инструкция по применению) or operating manual (руководство по эксплуатации).

The dossier must include colour mock ups of packaging and labels showing both the original marking text and the additional Russian language marking applied to devices manufactured outside Russia.

All medical devices including in vitro diagnostics intended to be marketed in Rwanda must be labelled in at least one of the official languages used in Rwanda; further detailed labelling requirements are set by the relevant guidelines. The device registration guideline's submission requirements include legible copies of the primary and secondary packaging labels, the package insert or instructions for use where required, e labelling details where applicable (including the form of e labelling, risk management, and how users are told in relevant languages where the IFU and further information can be found), healthcare professional labelling and patient labelling. All information may be submitted in any of the official languages of Rwanda.

Instructions for use are not required (or may be abbreviated) in duly justified exceptional cases where the device can be used safely and as intended without them. For professional use devices, IFU may be provided electronically subject to the e IFU requirements: a documented risk assessment covering at least 9 elements, and retention of the e IFU for at least 2 years after the expiry date of the last produced device (expiry dated, non implantable) or 15 years after the last device manufactured (no expiry date and implantables).

Information supplied by the manufacturer for devices used by lay persons must be in both Arabic and English. English only labelling is accepted where the user is professionally qualified. Labelling must not include the SFDA logo but may include the Medical Device National Listing Number; symbols must conform to SFDA.MD/ISO 15223 1.

The manufacturer must establish, in the national official language, the technical documentation required for the conformity assessment, the identification and the use of the medical device, and must establish a declaration of conformity and affix the conformity marking once the product has been shown to meet the applicable essential requirements. The UEMOA harmonised dossier adds that the summary of the device's characteristics and technical specifications must be in the country's official language and that the labelling model and the instructions for use model are filed with the dossier, and that the labelling, outer packaging or instructions for use of devices imported into the Community must additionally carry the name and address of the responsible person, the manufacturer's representative or the importer established in the Community.

Where a device and accompanying equipment are used exclusively by healthcare professionals, the manufacturer may provide the instructions for use in electronic form instead of paper; before placing on the market it must carry out a risk assessment and ensure the electronic IFU poses no risk to public health.

Instructions for use accompanying devices on the Serbian market must be written in Serbian and fully comply with the original manufacturer's text; under the labelling bylaw the IFU is in Serbian, indelible, legible and comprehensible, is submitted to ALIMS at registration/renewal/amendment, and information necessary for safe use must be in Serbian (except packaging of devices for professional use).

Outer and inner packaging of devices for professional use must be marked in Serbian or English; devices the patient uses independently must be marked in Serbian (original packaging in Serbian, or foreign packaging with an additional Serbian sticker containing all prescribed data). Batch numbers must be marked where rational and feasible; the AR name and registration decision number may be on a sticker.

All information on the label of a medical device must be provided in English and may in addition be provided in any other language (reg 16(2)).

Devices must be supplied with the information specified in reg 15, including an appropriate control number such as a batch code, lot number or serial number, and statements such as 'For Clinical Trial Use' where applicable; the manner of providing the information is set out on the Authority's website.

Paper versions of all labelling must accompany the product unless specified otherwise. Software user instructions may be supplied on electronic storage; for devices not sold to the general public, IFU may be paper or non paper and may be supplied with or separate from the device. Where IFU are not on paper, the owner must tell users how to view the correct version, and internet addresses used for electronic labels must be printed on the physical label. All labelling characters must be in English.

The label (označenie/štítok) and, where a device is supplied with one, the instructions for use of a medical device or IVD made available in Slovakia must be in the Slovak language. National legal basis: § 110b ods. 1 of zákon č. 362/2011 Z. z. (alongside MDR Art. 10(11) and IVDR Art. 10(10)). Labelling may alternatively use the symbols of EN ISO 15223 1 or EN 980.

The following must be in Slovenian: labels and instructions for use (MDR Annex I section 23 / IVDR Annex I section 20) intended for laypersons (nestrokovnjaki), field safety corrective action notices, clinical investigation summaries, and documents used to obtain informed consent.

Labels and instructions for professionally used devices must be in Slovenian or another language understandable to the user; if the instructions for use are not in Slovenian, the supplier must, at a health institution's request, immediately and at the latest within ten days provide the instructions for use in Slovenian.

Conformity documentation, the EU declaration of conformity, certificates, labels and instructions for use for professional users (MDR Annex I section 23 / IVDR Annex I section 20), software interfaces and the technical documentation referenced in the regulations may be in Slovenian or English.

The instructions for use of a medical device must contain the prescribed information in at least English (reg 23(1)); the IFU of an IVD must likewise be in at least English and must be included with the sale of each IVD, except that IFUs for Class A IVDs must be included only where applicable (reg 24).

The label of each medical device or IVD must contain: name/trade name, product description and intended use, catalogue code (where applicable), name and business address of the manufacturer and of the holder of the certificate of registration, scheduled/biological substance indication, lot number, serial number (control number for accessories, version number for software), expiry date (or manufacturing date), special storage/handling conditions, sterile state and sterilisation method, net quantity, warnings/precautions, and indications for single use, clinical investigation, non clinical research, presentation, IVD use, or professional/near patient/point of care/self testing; the label must be in at least English and appear on the device itself or the packaging of each unit and of multiple devices.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year month (use by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

For implantable devices, the information accompanying the product (including the implant card, per Article 18(1) of Regulation (EU) 2017/745) must be provided in Spain at least in Spanish; RD 192/2023 art. 36 also addresses national implant registries.

Importers and distributors must ensure that devices are accompanied by the Spanish language data and information, both on the labelling and in the instructions for use, as required by RD 192/2023 art. 5.2.

IVDs placed into service in Spain must bear the information required by section 21 of Annex I to Regulation (EU) 2017/746 at least in Spanish; the RD 942/2025 linguistic regime also requires notified body related documents and genetic test consent forms to be provided at least in Spanish.

At the moment of putting into service in Spain, medical devices must include the data and information of section 23 of Annex I to Regulation (EU) 2017/745 at least in Spanish (castellano), so that certain, objective, truthful and sufficient information on their essential characteristics is available.

A Patient Information Leaflet in Sinhala, Tamil and English languages is required for point of care medical devices; product labels (original/artwork/draft) and IFU (if applicable, per prescribed guideline) are dossier requirements.

Field Safety Notices (FSN) for the Swedish market must be written in Swedish and sent to all affected users, distributors and importers.

Patient information for implantable devices that the manufacturer must supply under MDR Art. 18.1 must be in Swedish, but the information on the implant card accompanying the product may be in Swedish or English.

Users of medical devices in Sweden must have access to information in Swedish: labelling, instructions for use and other information supplied with the product must be in Swedish, including control panels/displays and user interfaces on the product and in stand alone software. Legal basis: 3 kap. 1 § förordning (2021:631) (national requirement beyond MDR/IVDR).

Product information (labelling and instructions for use) must be in the three official Swiss languages (German, French, Italian); symbols concretised by technical standards may replace language statements. The product information may be limited to fewer than three official languages or to English if the product is supplied exclusively to healthcare professionals, or is a custom made device or a device manufactured in a health institution (Art. 9).

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.

e IFU is eligible only for devices limited to professional users; users must always be able to obtain the content in paper form on request, without undue delay or within the risk assessment period, at no additional cost; the web address must be printed on the physical label. Paper form IFU is required for home use devices (electronic additional IFU optional).

Manufacturers of implantable devices must supply an implant card and patient information including device name, serial number, lot number, UDI and device model plus manufacturer name/address/website, stated in Kiswahili and English, readily understandable by lay persons and updated via the website; health institutions must give it to implanted patients with the card bearing their identity. Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors are exempt.

Use of Kiswahili is required for home use medical devices (labels and IFU).

Any TMDA logo is prohibited on medical device labelling; statements naming TMDA or the Ministry of Health Tanzania are prohibited in all labelling unless required by the Ministry (considered Authority endorsement).

Labels and instructions for use for products marketed in Tanzania must be in English and/or Kiswahili; Kiswahili is required for home use medical devices; other languages may be used as necessary. Applications and supporting documents may be in Kiswahili or English.

Registered establishments, licensees, detailed listing notifiers and notifiers that manufacture or import devices must provide labels and accompanying documents (IFU) that do not show false or exaggerated statements; display follows ministerial notification criteria, and sellers must ensure labels/IFU are present.

The Ministerial Notification on medical device labelling B.E. 2568 (announced 27 November 2025; Royal Gazette เล่ม 142 ตอนพิเศษ 397 ง, pages 19 24, 22 December 2025) takes effect 20 June 2026.

A labelling mock up is a required part of the Tunisian medical device dossier: item m of the avis technique list requires a mock up of the sales packaging labelling, and item m's pack size rules are specific — for individual and multiple packs containing at most 10 articles, the samples must be supplied in their secondary sales packaging; for multiple packs containing more than 10 articles, secondary packaging is not necessary and only a mock up or a copy of the secondary packaging labelling may be supplied. The same duty appears on the import side: the administrative AMC requires a copy of the labelling (labelling mock up) or any other document identifying the articles by trade name.

Where the EU declaration of conformity is drawn up in other languages, a Turkish translation must be annexed to it.

The 2026 amendment to the electronic IFU communiqué (RG 22.04.2026, No. 33232) allows instructions for use to be provided electronically instead of paper for professional users, keeps paper for lay users, adds a definition for fixed installation devices and links e IFU information to the UDI database; it entered into force effective from 16/7/2025.

Field safety notices to users must be drawn up in Turkish and/or the official EU language(s) determined by the EU member states where the field safety corrective action is taken.

Information supplied with implantable devices (implant card) is presented in Turkish and, where necessary, together with its English version.

Reg. 29(1) of S.I. 2014 No. 29 requires the applicant to submit with the registration application a label carrying: the name of the surgical instrument; the name and address of the manufacturer; the identifier of the surgical instrument, including the identifier of any instrument or appliance that is part of a system, test kit or group; an indication of package contents where they are not readily apparent (size, net weight, length, volume or number of units); the word 'Sterile' if the manufacturer intends the device to be sold in a sterile condition; the expiry date where applicable, determined on the basis of the component with the shortest projected useful life; the medical conditions, purposes and uses for which it is manufactured, sold or represented, including performance specifications necessary for proper use, unless self evident to the intended user; the directions for safe and effective use, unless directions are not required; and any special storage conditions. Reg. 29(2) requires that information to be provided in English, in a permanent and prominent manner, in terms easily understood by the intended user. Reg. 35 adds that where a surgical instrument or appliance is intended to be sold to the general public, the reg. 29(1) information must be set out on the outside of the package and be visible under normal conditions of sale, and where the package is too small, the directions for use must accompany the device.

Labels must carry the manufacturer's name/trademark and address, batch code or serial number where applicable, the date until safe use is guaranteed (year and month), and any special storage and/or handling conditions.

Instructions for use are placed in the packaging of every medical device, but are not necessary for class I and class IIa devices that can be used safely without such instructions.

For devices imported for placing on the Ukrainian market, the name and address of the authorized representative must additionally appear on the label, or outer packaging, or in the instructions for use, where the manufacturer is not a Ukraine resident.

User information supplied by the manufacturer (label and IFU content per Annex 1) must comply with the Law of Ukraine 'On ensuring the functioning of Ukrainian as the state language', i.e. effectively Ukrainian; correspondence and records under the conformity procedures are subject to the same law.

The internal and external label and printed or electronic leaflet must match the package information in the marketing approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.

For general medical devices put into service in Great Britain, the label and packaging information requirements (Annex I Sections 8.7 and 13) and the instructions for use requirements (Annex I Sections 11.4 and 13) are complied with only if the information and instructions are in English, whether or not they are also in another language and whether or not the device is for professional use.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

Where the UKCA marking has been affixed, the name and address of the UK responsible person must be included on the product labelling or the outer packaging, and in the instructions for use; UKRP details are not required for CE only marked devices unless the device bears both CE and UKCA markings. Importer/distributor details are not required on the label unless the importer or distributor acts as the UK responsible person.

All registration and listing information submitted to FDA for a foreign establishment must be in English (21 CFR 807.40(d)).

All regulated products must be labelled and carry user instructions and technical information; the labelling, in Spanish, must state: a) product name and container content; b) lot number and, where applicable, manufacturing date and expiry; c) name and address of manufacturer and importer and country of origin; d) MSP product registration number and responsible Director Técnico name; e) instructions for safe use; f) sterilisation date, method and expiry (if applicable); g) storage/conservation/handling conditions and reusable status; h) warnings. Items a) to c) must appear on the primary packaging. Equipment whose dimensions permit must bear name, address, telephone and contact details of the responsible company.

Registration dossier must include labeling and packaging information with color mock ups (13 18 cm) and labeling text in the state (Uzbek) language, and for foreign manufacturers in Russian or English; the instructions for use / application instructions must be in the state language and in Russian or English. The Centre's Director agrees the instructions for use and labeling.

Where the Vietnamese instructions for use and the warranty information do not accompany the device, they must be supplied in electronic form, and the device label must clearly show how to look up that information.

A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty service, warranty condition and warranty period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

Warranty service, warranty condition and warranty period information is not required for single use devices so designated by the product owner, or for devices with documentation showing they carry no warranty scheme; devices holding an import licence under Art. 48(1)(a) (đ) are also exempt from the warranty information condition.

statement: Device labelling content and instructions for use are governed by ZAMRA's Guidelines for Label and Instructions for Use for Medical Devices, an adaptation of the GHTF document GHTF/SG1/N70:2011. An application must include at least two samples of the device in the smallest commercial pack size labelled primarily in English, sample instructions for use and a mock up label; applications and supporting documents must be in English. The label should carry the name or trade name of the device, details necessary to identify the device and its use, the name and address of the manufacturer, and, for imported devices, the name and postal address of the authorised representative, importer or distributor established in the importing country, which may be added by that party without obscuring the manufacturer's labels. The guideline recognises that a regulatory authority may authorise labelling in one or more languages other than its national language provided safe and correct use is ensured, and encourages the use of internationally recognised symbols.

statement: Condom labelling is prescribed by regulation rather than by guideline: every condom must be sealed in an individual pack stating the date of manufacture and the date of expiry, and each package of condoms must state the name and address of the manufacturer. No instructions for use requirement and no language requirement is stated in the regulations.

statement: Each package of gloves must state the name of the manufacturer and place of manufacture, the date of manufacture, the batch number, the date of expiry if any, the size of gloves, the methods of sterilisation if any, any warnings, the type of lubrication and the intended use. No instructions for use document and no language requirement is prescribed.