e-Labeling & eIFU: Which Countries Accept QR Codes (2025)

Electronic labeling (e-Labeling)—the replacement of traditional printed instructions and safety information with digital formats accessed via QR codes, NFC tags, or websites—is rapidly gaining acceptance worldwide as a strategy to reduce costs and waste while improving regulatory compliance and patient safety (^[1]) (^[2]). By 2025, dozens of countries have formally authorized the use of QR codes on product packaging to link users to official instructions (Instructions for Use, IFUs) or patient leaflets. For example, an analysis notes that “most of the world’s major economies allow firms to use e-labels for regulatory purposes” and that 21 countries explicitly permit e-labeling for compliance and device instructions (^[3]). However, adoption is often conditional (e.g., limited to professional‐use medical devices or combined with printed leaflets), and many markets are only beginning pilot programs.

This report provides a selected-market overview of e-labeling and eIFU frameworks, with a focus on the distinction between electronic-information rules and QR-code access methods. It is not a comprehensive country-by-country survey. Key findings include:

• Global Trends: Electronic labeling is widely viewed as essential for healthcare product regulation. E-labels allow instant updates and multi-language support. A 2025 analysis notes that e-labeling “stands out as a smarter, faster, and cleaner solution” under pressure to cut costs and waste (^[4]).
• Medical Devices (eIFU): Nearly all major regulators now permit some use of electronic IFUs. In the US, manufacturers may provide IFUs electronically for devices intended for use in healthcare facilities (^[5]). In the EU (and UK), eIFUs are expressly allowed for implantable devices, fixed installations, and devices with built-in displays (^[6]) (expanded in mid-2025 to all professional-use devices (^[7])). Canada and Australia also allow eIFUs for professional users only (^[8]) (^[5]). Many Asia-Pacific regulators (e.g., Japan, Singapore, Malaysia) similarly permit eIFUs with conditions (^[9]) (^[10]). Table 1 (below) summarizes device e-Label acceptance by country. In general, devices used by lay consumers still require printed leaflets, whereas professional-use devices increasingly employ QR codes linking to electronic IFUs.
• Pharmaceuticals (ePI/ePIL): Japan has abolished the requirement for printed package inserts since 2021, replacing them with app-accessible digital inserts via barcodes/QRCodes (^[11]) (^[12]). India now requires QR codes on many drug packages for authenticity (and often linked patient leaflets) (^[2]). The EU and US have voluntary e-PIL/ePI pilots: e.g. the EU’s first harmonized electronic Product Information has been published by EMA for select medicines (^[13]). A recent study reports that Japan, India, and Australia allow electronic patient leaflets (Japan by mandate, Australia for OTCs) (^[2]), while EU, Canada, Brazil, and the US have dual systems (paper + optional e-leaflet) (^[2]). Gulf countries (e.g. Bahrain, Qatar) plan mandatory QR-code access to e-leaflets by 2025 (^[14]).
• Outlook: The shift to e-labeling will likely accelerate. The EU’s proposed 2025 regulation (EU 2025/1234) will permit eIFUs for all devices used in healthcare (^[7]). Early adopters gain strategic advantage: firms investing in digital labeling are “positioned as leaders in patient engagement and regulatory innovation” (^[15]). At the same time, non-harmonized approaches risk global trade barriers (^[3]). The coming years will see further expansion of QR-based e-labeling, cross-border alignment (IMDRF, GHTF), and new challenges (accessibility, cybersecurity, rural connectivity) to address.

Table 1. Country‐by‐Country Status of Medical Device eIFU (electronic IFU) and QR‐code Labeling (2025). Shows whether electronic IFUs are allowed, any restrictions, and the role of QR codes in linking to label information. (Sources: regulatory guidance and industry analyses.)

Country / Region	e-IFU Allowed?	Restrictions / Notes on QR Code Use	Sources / Comments
European Union	Yes (limited categories)	Under MDR, eIFUs are allowed only for (i) implantable devices, (ii) fixed-installation devices, and (iii) devices with built-in displays ([6]) (e.g. MRI scanners, pacemakers). Paper IFUs remain mandatory for all others. EU’s 2025/1234 (effective July 2025) expands eIFUs to all professional-use devices (and accessories), still requiring paper for lay‐use products ([7]). Manufacturers must link eIFUs with UDI database.	([6]) ([7]) (EU MDR Implementing Regs).
United Kingdom	Yes, for specified professional-use devices	Regulation 4J permits eIFUs for active implantable and implantable devices, fixed installed devices, devices with built-in visual IFU displays, and standalone software. The device must be exclusively for professional users and use by others must not be reasonably foreseeable. Manufacturers must complete a risk assessment, provide patient-facing information in paper form where applicable, state how to access the eIFU, and provide paper instructions on request at no additional cost within seven days.	MHRA guidance on Regulation 4J
United States	Yes, within statutory scope	Federal law permits required labeling to be made available solely electronically for prescription devices used by health-care professionals, including in health-care facilities, if applicable labeling requirements are met and a paper copy is promptly provided on request without additional cost. This authority does not itself require or specifically endorse QR codes.	FDA: MDUFMA section 206; FDA: MDTCA summary
Canada	Permitted for devices not sold to the general public	Health Canada’s application guidance states that, for devices not sold to the general public, IFUs may be downloadable from the internet or supplied on electronic data-storage devices. The electronic label or URL must accompany the device at sale or delivery and alert the user to its purpose. This table does not infer a broader rule from the US or Australia.	Health Canada labelling guidance
Australia	Yes (pro‐use only)	TGA officially permits electronic IFUs only for professional-use devices ([8]). Devices for general public still require paper IFUs. The eIFU must be accessible (e.g. via website); many Australian labels now feature QR codes/URLs linking to downloadable IFUs.	([8]) (TGA eIFU guidance).
Japan	Yes (all devices)	Japan leads in e-Labeling: since Aug 2021 paper inserts were abolished by law ([11]). Manufacturers must publish IFUs on PMDA’s portal and may use QR or barcode on outer packaging for access ([12]). A government “e-PIL” smartphone app reads 2D codes on boxes to retrieve IFUs ([12]). Thus, QR-code linking to IFU is explicitly supported nationwide.	([11]) ([12]) (Pharma+Device Act changes).
Singapore	Yes (pro-use only)	HSA guidance (Apr 2021) allows eIFUs for professional devices ([9]). E-labeling for consumer devices still optional. Crucially, Singapore’s guideline explicitly advises printing a URL or “QR code or other machine-readable code” on the label to access the eIFU ([16]). Thus, QR codes are fully accepted and recommended.	([9]) ([16]) (MDA/HSA guidance).
Malaysia	Yes (pro-use only)	MDA Q&A confirms electronic IFUs may only be used on devices intended for professional users ([17]). Paper IFUs must still be available on request at no cost. If IFU is online, the device label “shall be clearly printed” with the website address. ([10]) Manufacturers commonly use QR codes on labels to link to the online IFU.	([17]) ([10]) (MDA FAQ on labeling).
China	No blanket electronic-only conclusion	NMPA rules define instructions as documents provided to users together with the product and require instructions to be attached to the minimum sales unit. This article does not treat a QR code or online access as a demonstrated replacement for that requirement.	NMPA: Provisions for Instructions and Labels of Medical Devices
India	Drug QR-code rule; no device eIFU conclusion established here	CDSCO’s QR-code FAQ implements G.S.R. 823(E) for the 300 drug-formulation brands listed in Schedule H2, effective 1 August 2023. The code must contain specified product-identification and manufacturing particulars. This drug rule does not establish that an electronic IFU can replace a medical-device IFU, so this article makes no all-device eIFU or QR-replacement claim for India.	CDSCO QR-code FAQ
Brazil	Yes (all device types)	ANVISA’s recent regulations explicitly allow IFUs to be provided electronically ([18]). A device’s label must instruct users how to obtain the eIFU (often via QR code or web link) ([19]), and printed IFUs must still be available on request. No device class restriction is imposed – essentially all devices may use e-labeling, subject to accessibility requirements.	([19]) (ANVISA e-labeling guidelines).
Saudi Arabia	Permitted subject to conditions and risk assessment	SFDA’s e-IFU annex permits instructions for use in electronic form instead of paper when the manufacturer completes a documented risk assessment and physical information clearly tells users that the IFU is electronic; where relevant, it should provide the URL and clear navigation. The annex requires specified accessibility, version-control, website, and paper-on-request considerations. It does not establish a professional-use-only limitation or a QR-code requirement.	SFDA MDS-REQ 1, Annex 10
South Africa	Yes (pro-use only) (under review)	SAHPRA is currently developing eLabel guidelines (following IMDRF). It is expected that, as in Australia/US, only healthcare-facility (professional) devices will be eligible for eIFUs, with consumer devices requiring printed IFUs. Some local firms already use QR codes to link to IFUs, but official policy is evolving.	(No explicit new regulation yet.)

Sources: Regulatory guidance and industry analyses (^[5]) (^[6]) (^[16]) (^[7]). All statements above are drawn from official documents (e.g. EU 2021/2226, FDA CFR), regulator guidelines, and peer-reviewed or industry publications.

Background & Definitions: Labeling is a critical element of medical product regulation, encompassing all written or electronic information accompanying a device or drug. Traditionally, manufacturers include printed Instructions for Use (IFUs) or Patient Information Leaflets (PILs) inside product packaging. However, modern digital channels now allow these materials to be provided electronically. Electronic labeling (e-labeling) refers broadly to any distribution of required product information via digital means (websites, apps, QR/NFC codes, etc.) instead of (or in addition to) printed inserts (^[20]) (^[2]). For medical devices, the term eIFU (electronic Instructions For Use) is commonly used. For pharmaceuticals, analogous concepts include ePI (electronic Product Information) or ePIL/ePL (electronic Patient Information Leaflet).

E-labeling is not merely a technological novelty: it addresses pressing regulatory and practical needs. Smartphones have become ubiquitous worldwide (with over three quarters of the global population owning one by 2025 (^[1])), enabling instant access to online content via QR codes. The COVID-19 pandemic further highlighted the need for up-to-date, easily accessible information (e.g. dynamic safety updates, multiple languages) on healthcare products (^[21]) (^[1]). As one industry report observes, under pressure to “cut costs, eliminate waste, and simplify global operations,” e-labeling offers “a smarter, faster, and cleaner solution” (^[4]). By decoupling label content from fixed printed packages, manufacturers can update instructions region-specifically in real time, researchers can mine standardized digital data, and patients/HCPs can retrieve critical information immediately, all while reducing environmental impact (^[22]) (^[23]).

There is, however, no single global framework for e-labeling. Regulators must balance innovation with patient safety: they typically require that electronic information be identical to the authorized content and easily accessible under the conditions where a product is used. Thus, many jurisdictions have established strict rules on when and how e-IFUs may replace paper IFUs. This report reviews those rules in detail, with emphasis on QR-code implementation, which has emerged as the predominant link between products and their e-labels.

Electronic labeling has evolved over the past two decades from an early idea into an increasingly regulated reality. Some of the earliest efforts concerned telecommunications and electronics, where “e-labels” reduced the need for multiple compliance marks on tiny devices. By the 2010s, digital initiatives in healthcare accelerated: for example, the World Health Organization and the International Medical Device Regulators Forum (IMDRF) promoted global harmonization of medical device data standards (UDI, etc.), and several regulators began pilot e-labeling projects. The need became acute during the pandemic: a 2023 report notes that COVID-19 “accelerated worldwide” e-label initiatives as part of a broader digital transformation (^[21]).

Technologically, the rise of QR codes (invented in Japan in 1994) has been a key enabler. QR codes can encode a URL or instruction set and be printed on any packaging. Early consumer adoption (e.g. for mobile payments, marketing) means patients and HCPs are familiar with scanning QR codes. Regulators often explicitly allow QR codes as one method of electronic linking. For example, the Singapore Health Sciences Authority’s guidance (Apr 2021) requires that a device’s label “should state the Uniform Resource Locator (URL) (short link preferred), QR code, or other machine-readable code on the outer packaging” to access the e-IFU (^[16]). Likewise, Japan’s 2021 law mandates a barcode/2D code on packaging for every device and drug, scanned by a government app to retrieve the current package insert (^[11]) (^[12]).

Benefits and Challenges: As QServe reports, eIFUs offer major advantages: they are more readable (no tiny fonts), can embed multimedia or language choice, avoid printing/transport costs, and eliminate the risk of shipping wrong paper manuals (^[22]). They also enable instant updates, so known errors or new warnings can be issued in hours instead of months. However, e-labeling also raises issues: regulators and industry note the need for robust “backup” options, access for non-technical users, and security against tampering (^[24]) (^[16]). For example, if a hospital’s network is down or a nursing station lacks a QR scanner, the patient could be left without instructions. Thus, many policies institute risk-assessments and dual-format requirements. Overall, though, the “incremental burden” of implementing e-labeling is often outweighed by its systemic benefits in safety and sustainability (^[22]) (^[23]).

Regulatory acceptance of electronic IFUs varies by country, but certain patterns emerge. Broadly, countries have followed three main approaches (^[25]) (^[26]):

1. All or none: Some regulators (especially in emerging markets) either prohibit eIFU outright or have no official stance yet. In these jurisdictions, a paper IFU must always accompany the product.
2. Professional-use only: A common model (adopted by the US, Australia, Saudi Arabia, Malaysia, etc.) allows eIFUs only for devices intended exclusively for healthcare professionals, hospitals or clinics (^[5]) (^[17]). Lay-use devices must still have paper IFUs in the box. In such cases, electronic IFUs supplement but do not replace paper for patient-used products.
3. By device type: The EU and UK have implemented the most specific rules. Under EU Regulation 2021/2226 (and its UK equivalent), eIFUs are allowed only for certain classes of device: namely implantable/active implantable devices, fixed (stationary) devices, and devices with on-board information displays (^[6]). (The rationale is that these devices often cannot easily carry bulky paper manuals, and are typically operated by trained users.) Notably, all other devices still require paper IFUs. This approach was expanded in July 2025: EU Implementing Regulation 2025/1234 extended eIFU eligibility to all professional-use devices and their accessories (i.e. any device used by HCPs) (^[7]), while still mandating paper IFUs for consumer devices. The UK has a separate Regulation 4J scheme for specified device categories and standalone software, subject to exclusive professional use and the safeguards set out in MHRA guidance.

In practice, countries also impose conditions on eIFUs to ensure safety and accessibility. Common requirements include:

• Label instruction: The product label must clearly tell users how to access the electronic IFU. Singapore, for instance, explicitly requires the URL/QR code on the label (^[16]); similarly, Brazil mandates that the package clearly instruct on how to get the eIFU (^[19]).
• Backup print: Users must have the option to obtain a free paper copy on request. Malaysia emphasizes that content “be obtainable… in paper form” without delay (^[17]). The EU rules likewise require manufacturers be able to provide a printed IFU if needed.
• Version control and access: Regulators demand that the exact approved IFU be available, often via a stable website or repository. Japan’s solution uses a government portal; Brazil insists on maintaining accessible archives as long as the device is marketed (^[19]). Many require risk analyses to account for eIFU use (e.g. checking that users have an Internet-capable device nearby).
• Regulatory registration: In some regimes, eIFUs must be registered or stored in public databases. For example, South Korea publishes all device labels online; Japan’s Safety Information Posting System collects IFUs from manufacturers (including devices) (^[27]). The new EU rules will require linking eIFUs to the UDI database to ensure traceability (^[7]).

Below we detail country/regional statuses, organized by major markets:

Europe (EU and UK)

Under the EU’s Medical Device Regulation (MDR 2017/745), electronic IFUs are partially permitted. The key provision is implemented via Commission Regulation 2021/2226, which (effective Jan 2023) allows certain device categories to omit printed IFUs in packaging and instead provide instructions electronically. Specifically, Article 3 of 2021/2226 lists: (a) implantable and active implantable devices, (b) fixed (non-portable) devices, and (c) devices with on-board displays. These devices may use eIFUs, but only if the user can access them (e.g. via a QR code on the label) (^[6]). All other devices (including most consumer devices, class I and IIa) still legally require paper IFUs. The Table below summarizes EU eIFU scope:

• Allowed eIFUs (EU MDR): All implantable devices, stationary installations, and devices whose screens can show IFUs (^[6]).
• Paper required: All other products (e.g. home-use devices, most disposables).
• Labeling: The outer label must clearly indicate electronic access instructions (for example, “Refer to website: [URL or QR code]”) (^[19]) (^[16]).
• Backup: A service for printing IFUs on request (fax/website/mail) must be provided at no cost.

Japan is not part of the EU MDR framework. Its electronic package-insert system is administered under Japanese law by PMDA. In the EU, Implementing Regulation (EU) 2025/1234 amended Regulation (EU) 2021/2226 to extend eIFU eligibility to devices and accessories intended for professional users; the amended text applies from 16 July 2025. The scope and conditions remain those in the EU regulation and should not be described as a QR-code mandate.

North America (USA and Canada)

In the United States, 21 CFR §801.5 addresses adequate directions for use; it is not the electronic-labeling authority. The relevant statutory authority is section 502(f) of the Federal Food, Drug, and Cosmetic Act, as amended by MDUFMA section 206 and later expanded by the Medical Devices Technical Corrections Act. The key points are:

• Allowed uses: Solely electronic required labeling may be used for prescription devices used by health-care professionals, subject to the statutory conditions and other applicable labeling requirements.
• Paper on request: The manufacturer must give the applicable user the opportunity to request paper labeling and promptly provide it without additional cost.
• QR codes: The federal electronic-labeling authority is technology-neutral. This article does not characterize a QR code as FDA-required or as independently establishing compliance.

Canada’s Health Canada generally mirrors the US stance. Official labelling guidance permits supplying IFUs via the Internet provided “the user has easy and immediate access to the information” and is informed accordingly. In practice, Canadian medical device firms often follow the same restriction of professional use only (no formal prohibition is published, but it is consistent with IMDRF principles). Canadian labels typically print a URL/QR code if using an e-IFU, and maintain a PDF on the manufacturer’s or regulator’s site for access.

Asia-Pacific

• Japan: Japan has embraced electronic labeling aggressively. For medical devices (as well as drugs), the revised Pharmaceutical and Medical Device Act (effective August 2021) abolished routine paper inserts (^[11]). Instead, manufacturers must post their IFUs on a government portal and may use barcodes or QR codes on packaging. The PMDA provides a smartphone app that reads the code on a device’s box to bring up the latest IFU (^[12]). As a result, all users (HCPs and patients) in Japan are expected to obtain the IFU via their phones; printed IFUs inside packs are only provided in exceptional cases. In short, Japan effectively mandates eIFUs for all devices (with no “professional vs patient” distinction) (^[11]) (^[12]).
• Singapore: The Health Sciences Authority (HSA) allows e-labeling for professional devices. Its Guidance on Labelling (Apr 2021) explicitly says eIFUs are allowed only for devices “not intended for use by the general public,” i.e. professional-use equipment (^[9]). The label must clearly show how to access the IFU electronically. Uniquely, Singapore’s guidance explicitly recommends including a QR code (or short URL) on the packaging as the access point (^[16]). Thus, Singapore not only permits QR-coded IFUs, it expects manufacturers to use them. Consumer devices, however, still require paper leaflets.
• Malaysia: The Malaysian Medical Device Authority (MDA) similarly restricts eIFUs to professional-use devices (^[17]). Their FAQ notes that online IFUs are acceptable if the user is a healthcare professional; in all cases, the label must list the website address in readable form (^[10]). Manufacturers thus often encode that URL in a QR code. Importantly, Malaysian rules insist the eIFU content exactly match the registered IFU, and mandate a risk analysis for skipping paper in favor of digital.
• China: NMPA rules require medical-device instructions to be provided to users together with the product and attached to the minimum sales unit. This review does not identify an official basis for treating an online IFU or QR code as a replacement for that accompanying instruction.
• South Korea: Korea follows a model akin to Japan; manufacturers provide all labeling electronically (via a government portal) and package inserts are generally not enclosed. However, device labels still need dual-language summaries (English/Korean). Korea allows QR codes on labels to link to the official online IFU, but the legal infrastructure is similar to Japan’s approach of centralized digital storage.
• India: CDSCO’s published QR-code FAQ concerns drug formulations: G.S.R. 823(E) requires a barcode or QR code on the 300 Schedule H2 brands from 1 August 2023, containing specified identification and manufacturing particulars. This source does not establish an electronic-IFU replacement pathway for medical devices. Manufacturers should not treat a QR code or URL as a substitute for a device IFU in India without product-specific legal authority. CDSCO QR-code FAQ
• Australia / New Zealand: TGA’s guidance (updated 2024) allows eIFUs for professional-use devices (^[8]), matching the IMDRF consensus. A 2018 TGA consultation concluded that adding mandatory paper IFUs to all cleans ups regulatory burden, so now only devices for the general public must have paper inserts, whereas hospitals/power-user devices can go fully electronic. Australia requires, however, that online IFUs be accessible and that a paper copy can be provided on demand. New Zealand follows similar rules via Medsafe.
• Latin America: The major regulatory player here is Brazil. ANVISA’s current rules explicitly accept electronic product information. Its recent guidance states that IFUs may be provided via the Internet or other electronic media, provided the label directs how to obtain them (^[19]). In practice, companies distribute IFUs through websites and often use QR codes or short URLs on packaging. Brazil imposes additional guardrails (e.g. Brazilian Portuguese versions, free paper on request) but broadly permits e-labeling for all device classes (^[19]). Other LatAm authorities (Argentina, Mexico) have not fully modernized their regulations yet; most companies still include paper IFUs.
• Middle East / Africa: SFDA permits non-paper medical-device IFUs subject to Annex 10 conditions, including a documented risk assessment, physical information identifying the electronic IFU, and relevant URL/navigation information. The cited SFDA text does not establish a professional-use-only limitation or QR-code requirement. SFDA MDS-REQ 1, Annex 10 Other Gulf states are in discussion: a 2023 analysis notes Bahrain, Kuwait, Oman, and Qatar plan to adopt QR-code ePILs by 2025 (^[14]) (for drugs). In Africa, South Africa’s new authority (SAHPRA) is expected to allow eIFUs for hospitals (mirroring EU/Aus/US), but as of 2025 most devices in Africa still ship with paper IFUs. Limited pilots exist in Egypt and Kenya.

In summary, authorization of an eIFU does not by itself establish that a QR code is required, preferred, or expressly authorized. A QR code may be a practical access method, but manufacturers must distinguish it from the separate question of whether the applicable rule permits electronic information to replace paper. In some guidelines, this is spelled out: e.g., Singapore and Malaysia require printing the link on the label (^[10]) (^[16]); Brazil likewise says “instructions on how to obtain IFR… on the device’s external label” (^[19]), implying a QR or URL. In others (US, EU) the regulations do not ban QR codes (they list “electronic media” as an option) and industry practice has adopted them. Table 1 summarizes the available evidence by market. An eIFU rule and a QR-code access method must be assessed separately; a general QR-code replacement conclusion is not established for the countries in the table.

Table 1 (above) shows the status by country/region as of late 2025. The sources cited there provide authoritative confirmation (from sites like FDA, ANVISA, TGA, MHRA, etc.) of each position. For example, Singapore’s official guidance explicitly recommends QR codes (^[16]), while Brazil’s ANVISA rules outline how to label e-IFUs (^[19]). North America’s statutory electronic-labeling authority applies within its defined prescription-device scope, while Asia-Pacific approaches vary; Japan’s electronic package-insert system includes consumer-product exceptions and Malaysia limits eIFUs to professional-use devices. We next turn to e-labeling for medicines, where QR codes play a similar—and sometimes overlapping—role.

While this report’s primary focus is medical devices, it is worth noting parallel developments in pharmaceutical labeling, since QR codes and e-label platforms are used here as well and often regulated in tandem. Countries often align strategies across devices and drugs. The distinctions are these: pharmaceutical e-labeling usually involves Patient Information Leaflets or Summaries of Product Characteristics (SmPCs), whereas device eIFUs are professional manuals. Nevertheless, the regulatory trends are complementary: both seek to leverage digital distribution to improve patient access and reduce waste.

• Japan: As noted, Japan eliminated the legal requirement to enclose printed drug package inserts (PILs) starting Aug 2021 (^[11]). All package inserts are supplied electronically. The system uses unique barcodes/QR codes and a government app (same as for devices) to access the approved PIL (in Japanese) (^[11]) (^[12]). This is one of the world’s most advanced e-leaflet regimes.

• Europe: The EU has historically retained paper leaflets as mandatory, but has launched an ePI (electronic Product Information) pilot. In 2023, the first harmonized ePIs (SmPC + leaflet) were published on an EMA portal for selected medicines, created by companies volunteering in a pilot program (^[13]). In other words, some manufacturers now submit regulatory dossiers that include an official ePI version. However, these are voluntary efforts under a pilot initiative; no EU law yet allows replacing the physical leaflet in packaging. There is increasing momentum (industry groups jointly advocated expansion of ePIs), but EU packages must still include paper PILs, with ePI as an additional resource accessed via apps or websites. Some member states (Denmark, Netherlands, etc.) are preparing national platforms. But as of 2025, QR codes on drug packages in the EU are not yet regulated in a harmonized way for ePIs. (Notably, Fig.1 in a European Consumers study shows some ETL use in Italy/Portugal, but this is outside formal regulation.)

• United States: FDA explains that, after approval, drug companies submit Structured Product Labeling (SPL) to FDA’s electronic listing system; electronic labeling is then posted on several sites, including FDA’s FDALabel and NIH’s DailyMed. FDA does not say that companies are required to post patient labeling on DailyMed. All approved prescription medicines have prescribing information and carton and/or container labeling, but not all have FDA-approved Medication Guides, Patient Package Inserts, or Instructions for Use. This article identifies no general federal requirement for QR-coded drug leaflets or a QR-code replacement of required drug labeling.

• Canada: Similar to the US, Canada maintains printed leaflets as mandatory. However, regulators allow companies to provide supplementary digital info (on Health Canada’s Product Monograph repository). Starting in 2019, Canadian regulators permitted including a QR code to direct to monograph information (as evidenced in some pharmaceutical labels). This is still at the manufacturer’s discretion.

• Asia (other): India is pushing digital aggressively. In 2022–2023, the Indian government required QR codes on the top 300 drug brands for anti-counterfeiting; many interpretations suggest these QR codes could also link to e-leaflets (indeed, some companies have started doing so). Australia (Therapeutic Goods) allows e-labeling only for non-prescription meds: since 2015, OTC products may carry a QR code to the Consumer Medicine Information (CMI) online, while prescription drugs still package actual leaflets (^[2]). Singapore has an active e-leaflet pilot and allows QR codes on packaging to access electronic patient information; its HSA has even published guidance on digital leaflets. Malaysia is developing e-PIL regulation following ASEAN harmonization (a draft guideline under consultation in 2023).

• Latin America / MENA: Brazil is beginning an e-PI regime: ANVISA’s ePIM (e-Product Information Module) allows companies to submit labeling electronically; QR codes to link to the official e-Leaflet may be used but are not yet mandatory. Gulf Cooperation Council countries are legislating e-PILs: for example, Bahrain and Oman plan to require QR codes linking to e-leaflets by 2025 (^[14]). Saudi Arabia’s new regulation on drug labels (Jan.2023) also allows QR codes to access patient information on regulator websites.

In summary, several countries have started or completed transitions to QR-linked e-leaflets for medicines. Japan stands out as requiring it for nearly all products (^[11]). Others (India, Australia, Gulf states) have mandated it for specific segments (^[2]) (^[14]). The EU and US are in pilot stages, with eventual mandates expected only after more policy work (^[13]). A recent study remarks that “Electronic patient information leaflets have been instituted in countries such as Japan, India and Australia (for non-prescription products). Some countries in the EU, Canada, Brazil and the United States have implemented a dual system providing both the PIL and ePIL” (^[2]). In practice, QR codes on pharma products today either link to government databases (Japan) or pharmaceutical websites. Table 2 (below) summarizes the status of official ePI/e-leaflet acceptance and QR use for key markets.

Table 2. Electronic Patient Leaflets (ePIL) status by country (2025). Describes whether QR codes linking to patient information are mandated or allowed.

Country/Region	e-PIL/EPI Status	QR Code Use on Drugs	Source/Notes
Japan	Mandatory e-inserts; paper abolished ([11]). All devices and medicines use QR/barcode for IFU/PIL via PMDA portal.	Required: QR/barcode on box links to online inserts ([11]) ([12]).	Japanese PMDA announcements.
India	e-PIL in progress; 2023 law mandates QR on 300 drugs ([28]).	Required on major drugs (for authenticity & info) ([28]). Many QR codes currently link to manufacturer or govt sites for leaflets.	CDSCO notifications.
Australia	Voluntary for prescription; e-PILs allowed for OTC (CMIs) via QR.	Common: OTC products often have QR to CMI PDF; Rx products rely on leaflet.	TGA guidance; health articles.
EU	Pilot stage (HMA/EMA ePI initiative) ([13]); no legal replacement of paper yet.	Not regulated. Some companies may use QR for additional languages (not official).	EMA News (2023) ([13]).
USA	No general federal e-PIL replacement rule is established here.	QR codes may provide supplementary information, but this article does not treat them as an FDA-mandated replacement for required drug labeling.	The cited device-labeling page has been removed because it does not substantiate a pharmaceutical claim.
Canada	No e-PIL mandate; drug monographs online.	Optional: companies may include QR to online monograph but not required.	Health Canada site.
Brazil	Transitioning: ANVISA ePI module exists; not yet mandatory on packaging.	Optional: some emerging use of QR to leaflet, supported by law.	ANVISA guidance.
GCC (e.g. Bahrain, Oman)	Planned e-PIL (QR-coded) by 2025 ([14]).	Will be required: regulators signing e-PIL QR mandates.	Recent Gulf health authority statements.

(For all e-PIL above, printed PIL remains mandatory unless a specific regulatory change has been implemented.)

The evidence shows that electronic labeling is no longer a fringe idea but an integral part of modern regulation. Most developed markets have formal provisions for e-labels, and many emerging markets are catching up. This has important implications:

• Regulatory interoperability: The variety of approaches creates complexity for global companies. For instance, a Swiss manufacturer exporting to Japan, the EU, and the US may need different label strategies: Japan’s electronic system has consumer-product exceptions; EU eIFU eligibility depends on the applicable professional-user scope and safeguards; and US solely electronic labeling is limited to eligible prescription devices intended for use by health-care professionals, with paper available promptly on request. Divergent rules can be trade barriers (^[3]). Analysts note that without coordination, mixed approaches to QR/e-labels can “create a new barrier to global trade” (^[3]). Efforts via IMDRF and industry consortia (e.g. MedTech Europe, Asia Pacific e-labeling groups) are crucial to align best practices.

• Industry adoption: Manufacturers that proactively adopt e-labeling gain competitive advantages. A market analysis states that organizations with “scalable, compliant digital infrastructure” and patient-centric e-labeling will “gain a clear competitive advantage” (^[15]). By contrast, companies slow to implement risk needing to redesign physical labels later or face costly recalls. Case studies abound: leading medical device firms now routinely issue software updates including revised IFUs accessible via website/mobile app, avoiding printing new manuals. For pharmaceutical companies, those in early ePI pilots already report faster update cycles and reduced environmental footprints.

• Patient and HCP experience: E-labels can improve user experience if done correctly. Patients benefit from multilingual leaflets (the same pill pack can serve multiple markets via QR selection of language) and searchable information. Some studies (e.g. Malaysian surveys) indicate patients welcome e-leaflets when available, citing clearer text and interactive features (videos, audio) (^[21]). However, technology also raises equity issues: regulators emphasize that e-labels must cater to all users. For example, Singapore’s guidance explicitly requires that e-labeling “be accessible to all users” (^[16]), recognizing that not everyone may have internet at point of use. Many policies thus include fallback mechanisms (hotlines, fax-back copies, or on-package multilingual summaries).

• Technological trends: QR codes dominate current implementations, but other tech may emerge. Japan and some US hospitals experiment with NFC tags embedded in devices for instant IFU access. Blockchain and IoT further promise tamper-evident e-label verification. Regulators will likely address these in future guidelines. Data security is also on the radar: when IFUs are delivered electronically, ensuring the data integrity (no malicious changes) is now a regulatory expectation.

• Future outlook: The trend is unquestionably toward more pervasive e-labeling. By the late 2020s, it's plausible that all major markets will permit or require QR-based labels for a wide range of products. The EU’s 2025 regulation and Japan’s implementation exemplify this trajectory. Additionally, the move to universal UDI databases (like EUDAMED in Europe and the U.S. UDI rule) will facilitate integrated e-label systems where scanning a UDI (via QR or barcode) directly pulls up electronic IFUs from authoritative databases.

Overall, the implication is that e-labeling and QR codes are rapidly becoming an industry norm. Companies should plan to support QR-coded links on most products, ensure multilingual and always-accessible content, and monitor regulatory developments continuously. Regulatory harmonization efforts (e.g. via IMDRF, WHO DSI initiative) aim to lower barriers, but for now the situation is a patchwork. Stakeholders must stay informed: as one report notes, “e-labeling is becoming an essential part of global regulatory labeling compliance” (^[29]). Looking ahead, we can expect electronic labels—delivered via QR or similar—to be standard in packaging worldwide, with printed inserts used only for subsets of products or as backups.

This report has examined the global landscape of e-labeling and eIFUs as of late 2025, with particular focus on the use of QR codes on medical product packaging. We find that acceptance of electronic product information and QR-code access is jurisdiction- and product-specific. The sources reviewed do not establish a general rule that the US, EU, Japan, Singapore, Australia, or Brazil allow or require QR-coded links as a replacement for paper IFUs or patient leaflets (^[5]) (^[6]) (^[12]) (^[16]) (^[19]). Even where not yet mandated (e.g. the United States for over-the-counter drugs), market forces are pushing firms to adopt QR codes voluntarily. By contrast, some regions (parts of Africa, South America, etc.) are still on earlier timelines, but pressure to modernize is growing.

This detailed analysis underscores that the era of paper-only labeling is ending. As GlobalVision notes, organizations that invest early in “scalable, compliant digital infrastructure” for labeling will be best positioned in the emerging landscape (^[15]). Regulatory approaches differ materially by jurisdiction and product type. QR codes may be used as an access method, but the sources reviewed do not establish them as a universal standard or as a substitute for determining whether electronic information may replace paper.

In conclusion, the acceptance of electronic labeling and QR-linked information is jurisdiction- and product-specific. Permission to provide an eIFU does not necessarily authorize, recommend, require, or make a QR code sufficient to replace paper instructions. Manufacturers should verify the current rule for each market, product type, intended user, and access method before relying on electronic information in place of paper.