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Medical Devices Regulatory Services in South Korea
Your Partner for End-to-End Regulatory Affairs Services in South Korea, From Strategy to Registration and Post Approval Maintenance
Artixio offers extensive regulatory services to global manufacturers, facilitating smooth navigation of South Korea’s MFDS regulations.
The Ministry of Food and Drug Safety (MFDS) is the Regulatory body regulates the Medical Devices in South Korea. The registration makes sure that the devices meet safety and performance standards before they can be marketed.
Services:
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
Key Regulations for Medical Devices in South Korea
Medical Devices Act (MDA)
Classification of Medical devices
In South Korea, devices are classified to Class I, II, III, and IV depending on their risk level. Class I devices have low risk to patients, while Class IV devices are high risk, complex devices. Class I and a few Class II devices need certification by the NIDS, whereas new Class II devices, Class III devices and Class IV devices need approval by the MFDS.
Process for Registration of Medical Devices in South Korea
Documents Required for Registration of Medical Devices in South Korea
Administrative Documents:
- Application Form
- Supplementary Evidence
Technical Documentation:
- Intended Use
- Mechanism of Action (MoA)
- Operational (Functional) Structure
- Raw Materials
- Instructions for Use
- Test Specifications
- Clinical Trial Data (if applicable)
Artixio’s Medical Devices Registration Services in South Korea
Our Regulatory and Market Access experts based in South Korea, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in South Korea. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality regulatory affairs services to support your business needs.
Why Artixio?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience: Devices, Diagnostics, Combination Drugs, Software as Medical Devices (SaMD), Consumer Devices
Diverse Experience across Complex Therapeutic areas and Application Areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
Represent your organization and device in South Korea
FAQs
What is the requirement for quality management system (QMS) in South Korea?
The devices Manufacturers other than Class 1 must submit quality system documentation to receive certification to KGMP as part of the medical device registration process. It is specific to the manufacturing site and local applicant/importer and KGMP is aligned with ISO 13485:2016.
Doe the local representative for medical device registration in South Korea is required for foreign manufacturer?
Yes, to manage regulatory submissions and compliance foreign manufacturers must appoint a local authorized representative.
What is the validity of Medical Devices registration in South Korea?
The registration is valid for 5 years and can be renewed after that.
What are the requirements to be a license holder in south Korea?
To be a license holder, the manufacturer should have a registered place of business in South Korea with a full time quality responsible person. If foreign manufacturers, they can appoint a local agent/license holder to apply for registration of medical device in with MFDS.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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