Labeling requirements strategy

Medical Device Labeling Requirements by Country

A country-by-country comparison of mandatory label language, required label elements, Instructions for Use rules, and UDI status across Taiwan, South Korea, Singapore, and 13 other medical device markets — built around the labeling detail that most often blocks a launch in the final weeks before market entry.

Why labeling is a late-stage blocker

Labeling is one of the most common late-stage blockers in medical device market entry. Unlike classification or dossier structure, the final label and Instructions for Use content is usually locked only after a registration number, local agent identity, or approval date is confirmed — so translation and print production compete directly with the last weeks of the review clock, not an earlier planning phase. Poor-quality translation and label content that doesn't match the approved dossier are the single most cited trigger for a deficiency notice across the markets below, and professional medical-device-experienced local-language translation commonly needs 6-8 weeks of lead time that has to be budgeted in parallel with the technical dossier, not after approval.

Labeling requirements by country

Country	Mandatory language	Key required label elements	IFU rules	UDI status / deadline
Taiwan	Traditional Chinese mandatory on every label, outer package, and IFU (仿單); bilingual Traditional Chinese + English is common practice, but the Traditional Chinese content must remain complete and controlling.	19-element set: product/model name, registration certificate number (post-approval only), manufacturer name/address, Taiwan agent name/address, lot/serial, manufacturing/expiry dates, storage, sterility status, single-use indicator, intended use, warnings, UDI code, IFU reference.	仿單 (IFU) covers 11 content areas in Traditional Chinese, mirroring the label; electronic IFU (eIFU) is accepted for some categories, but a physical Traditional Chinese label on the device or immediate package remains mandatory regardless.	UDI data registered in TUDID under the Medical Device Labels Shall Bear UDI Regulations (effective 1 May 2021); Class III devices in scope from the effective date, Class II phased in by category (exact category deadlines unconfirmed).
South Korea	Korean mandatory on every label and IFU per MFDS Notice 2022-110; bilingual Korean + English is acceptable only if Korean is the primary, controlling language.	14-element set: product/model name, MFDS item-license number, KLH name/address, manufacturer name/address, manufacturing date, expiry date/lot, storage conditions, MFDS-approved warning phrasing, single-use indicator, sterility status, IFU reference.	Korean IFU covers device identification, indications, contraindications, warnings, adverse events, operating instructions, storage, sterilization, maintenance, disposal, and KLH contact information; eIFU accepted for some categories, but the physical label obligation is not removed.	Korea runs its own national UDI system (KUDI, GS1-aligned), integrated into UDIPORTAL; rollout phased by class since 2019 — Class IV first, Class III and Class II progressively brought into scope.
Singapore	English is the sole required labelling and dossier language under GN-23; no translation is required. Chinese, Malay, and Tamil may run alongside English, but adding them is a commercial choice, not a regulatory obligation.	HSA reviews sample labels, packaging, IFUs, training materials, manuals, and installation instructions as part of the dossier; the label must carry Registrant/Dealer contact details and, where applicable, the HSA registration number.	English IFU generally required, covering setup, operation, maintenance, and troubleshooting sufficient for safe use; IFUs may be omitted for certain defined low-risk device categories.	GN-36-R2 phased mandate integrated with SMDR/SIDREG: Phase 0 (1 Nov 2022) coronary stents/joint implants/IOLs, Phase 1 (1 Nov 2024) Class D, Phase 2 (1 Nov 2026) Class C, Phase 3 (1 Nov 2028) Class B; Class A voluntary.
Philippines	English and/or Filipino labeling is acceptable; no mandatory bilingual requirement is stated.	Product name, model number, manufacturer, importer, the CMDN/CMDR number (added post-approval), lot number, expiration date, and usage instructions.	Label drafts must be submitted to CDRRHR for review as part of the application; approved labels may not be changed without a formal variation notification.	No mandatory UDI system established yet, though it appears on the regulatory reform agenda; packaging compliant with GS1/HIBCC conventions is a forward-looking practice, not a requirement.
Indonesia	Bahasa Indonesia labeling is mandatory for all devices on the market; CE- or FDA-compliant English-only labeling is not sufficient on its own.	Manufacturer information, local distributor/license-holder information, product name, lot/batch and serial number, expiry date, IFU reference, and (where applicable) the Halal mark.	Bahasa Indonesia IFU required; translation and print-production lead time is commonly budgeted at 6-8 weeks and must stay in lockstep with any home-market labeling change.	No UDI system stated in the labeling section; a separate Halal-certification mandate is phased in by device class from 18 October 2026 (Class A) through 2039 (Class D), running alongside — not part of — UDI.
Thailand	Thai mandatory for home-use device labels/IFU; professional-use devices (used within a healthcare facility by trained staff) may use Thai or English.	Under the new labeling notification (effective 20 June 2026): product name, intended purpose, quantity, manufacturer/importer details, Thai FDA approval number, lot/version/serial number, manufacturing/expiry dates.	The new rule authorizes QR codes and electronic IFUs for the first time, particularly for software and connected devices; devices already compliant with the outgoing 2020 rule may continue using prior labeling until roughly June 2028.	UDI newly mandated on-label for Software as a Medical Device in risk categories 2-4 (moderate to high), effective with the 20 June 2026 rule; no general hardware-device UDI mandate is stated.
Vietnam	Vietnamese mandatory, no exceptions, per Decree 111/2021/ND-CP; product name, manufacturer, importer, registration number, and dates must all appear in Vietnamese.	Product name (Vietnamese), model number, manufacturer, importer, registration number, manufacturing date, expiry date, usage instructions.	Vietnamese-language Instructions for Use (Hướng dẫn sử dụng) are mandatory; translation quality is the most frequently cited trigger for supplementary-information requests.	Not yet mandatory; UDI is referenced in the regulatory reform agenda but was not enforced as of this verification round.
Malaysia	English or Bahasa Malaysia accepted under the Medical Device (Labelling and Packaging) Regulations 2012; no mandatory translation requirement.	Device trade name, manufacturer name/address, Malaysian AR name/address, intended use/indications, storage conditions, expiry date, batch/lot/serial number, warnings, MD conformity mark where applicable.	IFU follows the same English-or-Bahasa-Malaysia rule as the label; no separate translation mandate is stated.	Not stated in source — no UDI mandate identified in this page’s labeling section.
Japan	Japanese mandatory on every label and the electronic package insert (添付文書) per PMD Act Article 52.	Device name, intended use/effects/performance, MAH or D-MAH name/address, manufacturer name/country, approval/certification/notification number, lot number or manufacturing date, storage/expiration date, warnings/contraindications, single-use indicator, sterility status, UDI (GS1-128).	Professional-use devices require a mandatory electronic package insert registered with PMDA since August 2021, replacing the paper insert; non-prescription home-use devices remain outside this electronic-only requirement.	Japan UDI system aligned to the IMDRF Framework and the GS1 standard; high-risk devices brought into scope first from 2023, medium/low-risk devices progressively; data registered with MHLW/PMDA.
China	Chinese-language labeling and IFU mandatory; any foreign-language label must carry a corresponding Chinese translation.	Product name, model/specification, intended use, lot number, manufacture/expiry dates, Domestic Responsible Agent information, required warnings.	Governed by the Instructions and Labels Management Provisions for Medical Devices (《医疗器械说明书和标签管理规定》); no electronic-IFU provision is stated in this page’s labeling section.	China UDI database (not fully interoperable with GS1/HIBCC); phased — Class III/IVD mandatory since 2021, Class II progressive since 2023, full Class II coverage and Class I IVD reagents by 1 June 2027, all Class I devices by 1 June 2029; missing UDI data is now review-blocking.
Saudi Arabia	Arabic mandatory; a bilingual Arabic + English label satisfies the requirement, but an English-only label does not.	Product name, a brief intended-purpose statement, manufacturer name/address, Saudi Authorized Representative (SAR) name/contact, lot number, manufacturing/expiry date, sterility status where applicable.	Arabic IFU is typically required for professional/clinical-setting devices (implants, surgical equipment); more flexible for non-technical consumables but still recommended. A supplementary Arabic sticker label is commonly applied before the product enters distribution.	Not stated in source — no UDI mandate identified in this page’s labeling section.
Brazil	Portuguese mandatory on every label and IFU under RDC 751/2022; a direct translation of a CE or FDA label is not by itself sufficient — content must be built to Brazil’s own required element set.	Product name, intended use, manufacturer information/country of origin, BRH name/address, Cadastro/Registro number, lot number, manufacturing/expiration date, storage conditions, warnings, sterility status, single-use indicator.	Foreign-language original labels are permitted only if supplemented with a Portuguese adhesive label applied before the product enters distribution.	Not stated in source — no UDI mandate identified in this page’s labeling section (ANVISA is an MDSAP founding authority, but that is a QMS-audit reliance mechanism, not a UDI system).
Argentina	Spanish mandatory on every label, package insert, and IFU; English or Portuguese submissions are not sufficient. Translations of foreign documents must be performed by an Argentina-registered Traductor Público Nacional — an ordinary certified translation agency is not accepted.	Product/device name, manufacturer name/address/country, importer information (CUIT tax ID + ANMAT registration number), intended use, Certificado de Registro number, lot number, expiration date, storage conditions, warnings, sterility status, single-use indicator, UDI.	The same Traductor Público Nacional sworn-translation requirement applies to the IFU as to the label and supporting regulatory documents.	ANMAT has published a UDI roadmap referencing IMDRF guidance; Clase III/IV devices have begun phased UDI first, with Clase II expected to phase in roughly 2025-2028 (pace unconfirmed given the broader 2025-2026 reform wave).
Colombia	Spanish mandatory for labels, IFU, and all technical dossier documentation per Decreto 4725/2005; foreign-language labels are usable on-product only if supplemented with a Spanish adhesive label. Translations must be performed by a certified Traductor Oficial.	Manufacturer information, importer/Titular information, intended use, lot number, expiration date, storage conditions.	IFU must be in Spanish alongside the label; a standard commercial translation does not satisfy INVIMA’s Traductor Oficial requirement.	Per Resolución 1405/2022, a UDI-DI code (from GS1, HIBCC, ICCBBA, or another accredited agency) is required before commercialization for registrations granted on/after 8 February 2024; earlier registrations follow staged transitional deadlines by risk class (exact class-by-class dates unconfirmed).
Mexico	Spanish mandatory on every label, package insert, and IFU under the new NOM-137-SSA1-2025 standard, which replaces the 2008 standard and aligns to IMDRF labeling guidance; a straight translation built to the old 2008 element set is not automatically sufficient.	Product/device name, intended use, manufacturer information/country of origin, legal representative/importer name/address/Registro Sanitario number, lot/batch number, manufacturing/expiration dates, storage conditions, warnings, sterility status, single-use indicator, IMDRF-aligned symbols.	The new standard enters into force 360 calendar days after its 19 May 2026 DOF publication date (roughly May 2027), with a further 180-day allowance to sell through existing inventory labeled under the 2008 standard.	Not stated in source — no UDI mandate identified in this page’s labeling section.
India	English remains the standard label/IFU language; MDR 2017 does not impose a Hindi or regional-language mandate the way some Southeast Asian jurisdictions do.	Device/product name, manufacturer name/address, Authorised Agent/importer name/address/MD-15 licence number, batch/lot or serial number, date of manufacture and expiry/use-by date where applicable, storage conditions, intended use, sterility status/method where applicable, single-use indicator, warnings/contraindications, IFU.	IFU covers device description, indications, contraindications, warnings, and directions. Following the 2025 Legal Metrology carve-out, MDR 2017 Chapter VI is now the sole governing framework for label content, removing the prior dual-compliance overlap with Legal Metrology rules.	Not implemented — India has no comprehensive CDSCO-mandated UDI system comparable to the US FDA or EU UDI frameworks; UDI remains on the regulatory reform agenda.

Cross-country patterns

Labeling rules split into two clear groups across the markets covered here, and UDI mandates are moving in phased waves rather than all at once.

Markets that accept English

Singapore

Sole required language under GN-23; no translation obligation.

Philippines

English and/or Filipino accepted; no mandatory bilingual rule identified.

Malaysia

English or Bahasa Malaysia accepted; no mandatory translation requirement.

India

English remains the standard label/IFU language; no Hindi or regional-language mandate under MDR 2017.

Markets that mandate a local language

Thailand

Thai mandatory for home-use devices; professional-use devices may use Thai or English.

Vietnam

Vietnamese mandatory, no exceptions (Decree 111/2021/ND-CP).

Indonesia

Bahasa Indonesia mandatory; English-only labeling is not sufficient.

China

Chinese mandatory; any foreign-language label must carry a Chinese translation.

South Korea

Korean mandatory (MFDS Notice 2022-110); bilingual only if Korean is primary and controlling.

Taiwan

Traditional Chinese mandatory; a straight translation from a CE/FDA label is not sufficient.

Brazil

Portuguese mandatory (RDC 751/2022); foreign labels need a supplementary Portuguese adhesive label.

Argentina

Spanish mandatory; translations must come from a registered Traductor Público Nacional.

Colombia

Spanish mandatory (Decreto 4725/2005); translations must come from a certified Traductor Oficial.

Mexico

Spanish mandatory under the new NOM-137-SSA1-2025 standard, replacing the outgoing 2008 rule.

Saudi Arabia

Arabic mandatory; a bilingual Arabic + English label satisfies the rule, English-only does not.

UDI adoption wave

Wave	Countries
Already in force	South Korea (Class IV, since 2019); Taiwan (Class III, since May 2021); China (Class III/IVD, since 2021); Japan (high-risk devices, since 2023); Singapore (Class D, since November 2024); Colombia (registrations granted on/after 8 February 2024).
Live within the next 12-24 months (2026-2028)	Singapore Class C (1 November 2026); Thailand SaMD risk categories 2-4 (from the 20 June 2026 rule); Singapore Class B (1 November 2028); Argentina Clase II (roughly 2025-2028, pace unconfirmed).
Further out (2027-2029)	China full Class II coverage and Class I IVD reagents (1 June 2027); China all Class I devices (1 June 2029).
No UDI mandate stated in the source page	Malaysia, Saudi Arabia, Brazil, Mexico, and India — no UDI mandate identified in this page’s labeling section. The Philippines and Vietnam reference UDI on their reform agendas but report no current enforcement.

Explore the country pages

Each country name links to the full country regulatory report for registration pathway, timeline, cost, and post-market obligations.

Every row above links to the full country page for registration pathway, timeline, cost, and post-market detail — treat this table as a planning cross-reference, not a substitute for the country-specific Element 7 sections it draws from. For manufacturers sequencing several Southeast Asian or Northeast Asian markets together, pair this table with the Southeast Asia market-entry and Japan/South Korea market-entry topics, which cover the local-holder and reference-approval structure that sits alongside these labeling rules.

Browse all countries Southeast Asia entry playbook Japan & Korea entry playbook

Official sources

Taiwan TFDA medical device portal MFDS Korea English portal HSA Singapore medical device registration FDA Philippines / CDRRHR Indonesia Ministry of Health / Regalkes Thai FDA medical devices portal Vietnam Drug Administration (DAV)Malaysia Medical Device Authority (MDA)PMDA Japan English portal NMPA China English portal Saudi SFDA Brazil ANVISA Argentina ANMAT — HELENA filing portal Colombia INVIMA — SIRIS filing portal Mexico COFEPRIS — DIGIPRIS filing portal India CDSCO