Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
May 14, 2024
Approximately 5 minutes
South Korea Medical Device Labeling Requirements: MFDS Mandates and Korean Language Rule
South Korea Medical Device Labeling Requirements (MFDS)
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.
Language Mandate
The most critical requirement for foreign manufacturers is that all labeling, packaging, and Instructions for Use (IFU) must be provided in the Korean language.
Container and Outer Package Labeling
The container or outer package must clearly display a set of essential descriptive details, enabling easy identification and traceability:
- Manufacturer/Importer Information: Name and address of the manufacturer and the local importer. For imported products, the country of origin must also be stated.
- Product Identification: Product name (including title of product group and model name) and the Medical Device Standard Code.
- Regulatory/Lot Data: The Approval (certification or report) number and the Lot number.
- Date Information: Date of manufacture and/or the expiry date.
- Other Details: Weight or packing unit, a specific mark indicating the product is a medical device, and an indication if the product is for single-use.
Instructions for Use (IFU)
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:
- Detailed Instructions for Use and precautions.
- Maintenance and Inspection instructions, where applicable.
- Any additional specific information designated by the MFDS.
Related Articles
Approximately 5 minutes
South Korea Medical Device Registration: MFDS, KGMP, and the Substantial Equivalent Pathway
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
South Korea IVD Registration: Risk Classification and Expedited Third-Party Review
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
South Korea Post-Market Surveillance (PMS): Tracking, Vigilance, and Penalties
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
South Korea License Maintenance: Monthly Supply Reporting and Amendment Requirements
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.