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.
July 7, 2024
Approximately 5 minutes
South Korea License Maintenance: Monthly Supply Reporting and Amendment Requirements
South Korea Medical Device License Maintenance and Reporting
Maintaining market access in South Korea requires strict adherence to the Ministry of Food and Drug Safety (MFDS) requirements for license amendments and ongoing reporting. Failure to comply can lead to severe consequences, including license revocation and substantial administrative fines.
License Amendment Requirements
Manufacturers must proactively manage and report any changes to the specifics of their approved product license or certification, as mandated by Article 12 Paragraph (1) of the Medical Device Act.
- Mandatory Approval/Certification: Any change, including seemingly administrative ones such as a change in the location of the manufacturer, requires the manufacturer to first obtain approval or certification to file an amended report with the MFDS.
Mandatory Monthly Supply Reporting
The MFDS has established a mandatory system for monitoring the distribution and supply of medical devices across all risk classes (I, II, III, and IV).
- Legal Basis: This requirement is defined by Article 31-2 of the Korea Medical Device Act.
- Submission Details: Manufacturers must submit monthly reports detailing the supply of their medical devices. These reports are submitted through the "integrated medical device information system" using specific forms (e.g., Form 48-2).
- Reporting Deadline: Reports must be submitted by the end of the month following the supply of the medical devices.
- Staggered Implementation: The requirement was phased in by risk class, starting with Class IV devices (July 1, 2020) and eventually including Class I devices (July 1, 2023).
- Exclusions: This monthly reporting requirement does not apply to medical devices primarily used at home, such as Direct to Consumer (DTC) products.
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 Medical Device Labeling Requirements: MFDS Mandates and Korean Language Rule
Mandatory labeling for medical devices in South Korea is governed by the MFDS Medical Device Act. All labels, including the container and Instructions for Use (IFU), must be in Korean and contain specific identifiers like approval number, product name, and manufacturing data.
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.