Overview of APAC Regulatory Languages: Korea, Japan, Singapore, and China

Overview of APAC Regulatory Languages: Korea, Japan, Singapore, and China

The Asia Pacific (APAC) region is very active, evolving, and multicultural when it comes to health care, rules, and the economy. Its communities, cultures, economy, landscapes, and faiths are diverse. In addition to developed economies like South Korea, Australia, New Zealand, Taiwan, Hong Kong, Singapore, and Japan, the region is home to developing economies like China, India, Vietnam, the Philippines, Indonesia, Malaysia, Thailand, and others (Elegant, 2023). In order to help your teams work more quickly and remain compliant, Willingjet Life Sciences, a professional medical translation partner, can handle the following practical overview of four priority markets: China, Japan, Korea, and Singapore.

Languages Across Different Regions

China: Simplified Chinese language is required for device labeling and instructions, and registration dossiers are submitted in Chinese (with translations from international originals included). Drug labels and inserts must be in standard Chinese, as Chinese is the most widely used language.

Japan: Since August 1, 2021, device and IVD inserts have been digitalized (referred to as "e-package inserts"), with the Japanese package insert serving as the official labeling.

Korea: Hangul (Korean) must be used for labeling; in some circumstances, foreign languages may be used in addition to Korean (Enforcement Rule).

Singapore: In accordance with GN-23, device labeling must be in English (Lee et al., 2024).

What makes language a legal necessity

Package inserts for medications include important information about how to use them. However, they receive criticism for being tough to understand and for failing to give patients all the information they desire. Regulators in APAC link comprehensibility with patient safety: local language labeling fixes adverse events, guarantees consistent risk communication, and lowers usage mistakes. Translation quality is crucial for legal defense in China and Japan, where the local language version takes preference in the event of conflicts (Lee et al., 2024).

The International Medical Device Regulators Forum (IMDRF), which was established by the Global Harmonization Task Force (GHTF), has worked hard to bring together several aspects of medical device regulation. Since it started in 2011, the IMDRF has helped agencies from many places, like the US, the EU, China, Australia, Japan, and more, to work better together (Han & Bergmann, 2024).

Figure 1.  Labeling Standards by Market (Winson Teng, 2024)

China

●       China participates in the IMDRF Management Committee, which encourages compliance with international device standards, and is governed by State Council Order 739, which regulates medical devices and IVDs.

●       The basic idea is straightforward: when there are multilingual versions, Chinese takes dominance over other languages, and device labels and instructions must be in Chinese.

●       Translations must be delivered with the original application documents, which must be in Chinese.

●       Standardized Chinese characters must appear on drug labels and inserts; any other language must adhere to the Chinese version. (NMPA).

Structured multilingual content and metadata alignment are more important as China continues to increase the use of eCTD for medication applications (2025 scope expansion). Good Clinical Practices ensures that the informed consent form must be in a language that participants can comprehend, which is typically Chinese. This requirement applies to recruiting, diaries, and patient-facing materials (Lee et al., 2024).

What a Chinese translation partner should provide.

●       Labeling, IFU (Instructions for Use), and dossier translations into Chinese that are certified and have source traceability (table of concordance).

●       Harmonization of NMPA terminology and Chinese standards for device symbols and phrases.

●       Chinese risk communications (recalls, FSNs, and vigilance responses) with a tone and format appropriate for regulators.

Japan

In accordance with the Pharmaceuticals and Medical Devices (PMD) Act, Japan has been using an electronic package insert (e-PI) system for prescription drugs and certain medical supplies from August 1, 2021. English versions of the e-package insert only serve for reference; the Japanese version is the official labeling for medical professionals and takes the place of paper. On its website, PMDA posts the most recent official version. Barcodes or 2D codes are machine-readable codes that are on available packages. The insert can be accessed by users via an authorized smartphone app or by searching PMDA's website (Ph. & Pfizer R&D Japan, JPMA, 2024).

Figure 2. Options for Accessing e-Labels in Japan  (Lee et al., 2024)

What a Japanese translation partner should provide

●       IFUs and package inserts in high-quality Japanese that are prepared for e-labeling (stable attachments, code-linked content).

●       J-CTD alignment, which includes controlled terminology and uniformity between modules.

●     Change control is essential since PMDA updates safety sections quickly.

Korea

●       The Ministry of Food and Drug Safety (MFDS) is the national regulatory body in Korea that evaluates and keeps an eye on the quality, safety, and effectiveness of food, medications, medical equipment, and cosmetics.

●       The outside packaging of the pilot's participating manufacturers has a scannable code (like a barcode or QR code).

●       The user can access the company's electronic pamphlet by scanning it.

●       It is, however, necessary to provide paper inserts upon request (for example, to patients or facilities who require paper or do not have access to digital technology).

●       Hangul (Korean) must be used on containers, wrappers, exterior containers, packages, or package inserts. Foreign languages may be used with Hangul, subject to size and format restrictions (Lee et al., 2024).

Figure 3. e-labels in Korea (Lee et al., 2024)

What a Korean translation partner should provide

Along with IFU translations that correspond to authorized technical files, Korean labeling adheres to the MFDS format (Hangul order, font/legibility rules).

Clinical and regulatory content strategy in two languages (whole Korean for M1/M2; scientific modules with approved English reuse, where allowed).

Singapore

The Health Products Act/Medical Device Regulations govern how the HSA (Health Sciences Authority) regulates devices. Singapore serves as a regional center for trials and submissions and is a member of the IMDRF Management Committee. It is very clear from HSA's GN-23 guidance that device labeling (including IVDs) must be in English. HSA first restricted e-labelling to prescription items , but as of April 1, 2024, some non-prescription medications from the General Sale List and Pharmacy-Only may also take part in the pilot (Lee et al., 2024).

What a Singaporean translation partner should provide

We offer publication-grade English for labeling and IFUs, as well as quick repackaging for ACTD/CTD/eCTD content worldwide.

While English serves as the regulatory basis, locations may require localized patient information (such as short-form consent) in important local languages.

How APAC submissions are simplified by Willingjet Life Sciences (Medical Translation Company)

Structure that is ready for submission

For eCTD/CTD/J-CTD/K-CTD, our authors package content according to PMDA/ICH lifecycle alignment, sequence information, and Module 1 regional requirements (such as Singapore eCTD Module 1).

Legal translations of regulatory quality

We convert into the precise language required and reference relevant sections in our internal quality assurance. This safeguards you against audits and arguments involving discrepancies.

Fluency in labeling and e-labeling

We create device inserts/IFUs for print and electronic ecosystems (such as Japan's e-package inserts), maintaining local-language versions.

Clinical study materials approved by the IRB and IEC

In order to preserve readability, version control, and traceability, we draft informed consent forms and patient-facing materials in either English + Short-Form (Singapore) or the participant's native tongue (Chinese, Japanese, or Korean).

Post-market communication

To ensure that field workers and regulators receive precise, compliant instructions, we prepare FSNs/recall letters, surveillance reports, and safety updates using the local regulatory approach.

Conclusion

The Asia Pacific region is characterized by rapid change and progress, with numerous nations implementing measures to enhance their healthcare systems, such as raising compliance and safety standards. One aspect of compliance in APAC is language. China demands Chinese for all labeling and filings; Japan establishes the Japanese insert as the standard, and all inserts are digital; Hangul is required on labels in Korea. Singapore uses device labeling in English and a strong eCTD framework for medications. From initial submission to post-market revisions, your regulatory, clinical, labeling, and safety teams can remain in sync by transforming this complexity into a regulated flow with the help of a qualified medical translation partner like Willingjet Lifesciences.

References

Elegant, V. (2023). Medicines development in the Asia Pacific region. Journal of Medicines Development Sciences, 3(1). https://doi.org/10.18063/jmds.v2i1.142

Han, Y., & Bergmann, J. (2024). Transforming medical regulations into numbers: Vectorizing a decade of medical device regulatory shifts in the usa, eu, and china (No. arXiv:2411.00567). arXiv. https://doi.org/10.48550/arXiv.2411.00567

Lee, J., Yang, J., & Kwon, K. (2024). A comparative analysis of current status of electronically provided package leaflets (E-labels) among south korea, the united states, europe, japan, and singapore. Yakhak Hoeji, 68(4), 239–251. https://doi.org/10.17480/psk.2024.68.4.239

Ph., R. M., R., & Pfizer R&D Japan, JPMA. (2024, July 10). E-labeling implementation in japan and asia—From industries perspective -. - To Expedite the Launch of Innovative Medicines for the Peoples in Asia –. APAC.

Winson Teng. (2024, December 9). Regulatory perspective of e-labelling [Senior Manager, Regulatory Intelligence & Policy (Becton, Dickinson and Company) eLabel & eIFU Project Lead (APACMed]. 28th GHWP Annual Meeting and 28th GHWP TC Meeting, (Kuala Lumpur, Malaysia).