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May 14, 2024
Approximately 5 minutes
Medical device labeling in South Korea is strictly regulated by the Ministry of Food and Drug Safety (MFDS), as detailed in Articles 20-23 of the Medical Device Act. Compliance with these local requirements is mandatory for all registered products.
The most critical requirement for foreign manufacturers is that all labeling, packaging, and Instructions for Use (IFU) must be provided in the Korean language.
The container or outer package must clearly display a set of essential descriptive details, enabling easy identification and traceability:
The IFU serves as the primary source of detailed information for end-users and healthcare professionals. The insert may be provided in electronic or printed form and must include:
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ElendiLabs
这种做法是允许的。在韩国，这通常被称为“标识修正”。这类操作必须在具备 KGMP (Korea Good Manufacturing Practice) 认证的场所进行。如果进口商是已获预先批准的合法进口商，通常无需针对特定批次的批准即可更新外包装上的进口商名称/联系方式，但必须使用已获授权的韩国进口商的详细信息，有机会不需要为每一批次的操作申请单独审批，但作为进口商，必须建立相关的标识变更作业标准书（SOP），记录操作过程，并确保覆盖标签的粘性足够强，不会在流通过程中脱落。
peterong
针对我们即将出口到韩国的第三类植入式器械（仅供医生在手术室使用），我们是否可以完全取消纸质版使用说明书（IFU），而仅在最小销售单位的标签上印刷二维码（QR Code）？如果可以，MFDS 对二维码链接到的网页内容是否有特定的语言要求，是否必须托管在韩国境内的服务器上？
ElendiLabs
根据韩国《医疗器械法》，针对仅由医疗专业人员使用的特定器械，允许提供电子说明书。但是，您不能直接“取消”所有说明。您必须在器械标签或包装上明确标注“请参阅电子说明书”的字样及获取路径（如 URL 或二维码）。内容必须是韩语，且必须确保用户在没有互联网的情况下也能通过进口商索取到纸质副本。虽然不强制要求服务器物理位置在韩国，但页面加载速度和稳定性必须符合韩国用户的访问习惯。
johnfaith
我们的眼科手术刀片体积非常小，一级包装（直接接触产品的剥离袋）表面积有限，无法容纳所有法律要求的韩语信息（如：产品名称、型号、进口商、制造日期、许可证号等）。在这种情况下，MFDS 是否允许在一级包装上仅保留批号（Lot No.）和有效期，而将所有强制性韩语标识全部置于二级外盒（Secondary Packaging）上？
ElendiLabs
根据 MFDS 规定，如果包装空间受限，可以在一级包装上进行“简化标注”。通常必须保留的信息包括产品名称、批号和制造商名称（或商标）。然而，所有强制性的韩语法律标识（包括“医疗器械”字样、许可证号、进口商信息等）必须完整地出现在最小销售单位的二级包装（外盒）上。如果连外盒也无法容纳，则必须随附一份包含完整信息的说明页。
Anonymous
To maintain global packaging consistency, we prefer using ISO 15223-1 symbols (e.g., the factory icon for manufacturer, the "REF" icon for model number). Does the MFDS accept these international symbols as standalone headers, or must they be accompanied by their specific Korean translations (e.g., 제조원, 형명) to be considered legally compliant for the South Korean market?
ElendiLabs
While South Korea is increasingly harmonizing with international standards, the MFDS still requires certain "key headings" to be in Korean text. While you may use the ISO symbols, they generally cannot stand alone for the most critical regulatory information. According the South Korea’s Medical Device Act, at a minimum, the words for "Medical Device" (의료기기), "Importer" (수입원), and "Product Name" (제품명) must be in Korean. For other elements like "Storage Temperature" or "Single Use," symbols are usually sufficient without translation, provided they follow the recognized international standard.
Anonymous
South Korea has fully implemented UDI (Unique Device Identification) reporting. When designing the South Korean label, can the UDI-DI and UDI-PI (DataMatrix or Barcode) replace the plain-text "Manufacturing Date" and "Expiry Date" to save space, or does the MFDS mandate that these dates must be written in human-readable Korean text (e.g., 제조연월일 and 사용기한) regardless of the UDI carrier presence?
ElendiLabs
The UDI carrier does not replace the human-readable requirement. Even with a functional UDI barcode, the MFDS requires the Manufacturing Date and Expiration Date to be printed in a human-readable format. Furthermore, specific Korean terminology must be used (e.g., "사용기한" for expiry date). The UDI serves for tracking and reporting to the Medical Device Information & Technology Assistance Center (MDITAC), but the local label must remain accessible to the end-user without a scanner.
Approximately 5 minutes
A guide to South Korea's medical device approval process via the MFDS, outlining the classification system, the requirement for Korean Good Manufacturing Practices (KGMP), and the expedited registration routes based on the existence of a Substantial Equivalent (S.E.).
Approximately 5 minutes
An overview of the South Korean MFDS registration for In-Vitro Diagnostic (IVD) devices, highlighting the GHTF-aligned classification, the role of predicate devices (S.E.) in accessing expedited third-party review for Class II, and the Safety and Efficacy Review (SER) route.
Approximately 5 minutes
An overview of South Korea's Post-Market Surveillance (PMS) requirements under the MFDS, covering mandatory tracking devices, adverse event reporting, and the severe administrative sanctions for non-compliance, including fines and license revocation.
Approximately 5 minutes
License maintenance in South Korea requires manufacturers to report any license amendments to the MFDS and comply with mandatory monthly supply reports for all device classes (Class IV to I) via the integrated information system, excluding home-use devices.
Anonymous
如果我们的韩国经销商（即持证进口商/K-Holder）发生了变更，但目前保税仓库中仍有大量印有旧进口商信息的原包装。MFDS 是否允许我们在符合 KGMP 要求的仓库中，通过加贴覆盖标签（Over-labeling）的方式来更新进口商名称和联系方式？这种操作是否需要提前向 MFDS 备案？