Korea
Definition of medical devices
Under the Article 2 of Medical Device Act, a medical device is defined as follows.
"The term "medical device" in this Act means an instrument, machine, apparatus, material, software, or any other similar product, specified in the following subparagraphs as one used, alone or in combination, for human beings or animals, provided that drugs and quasi-drugs under the Pharmaceutical Affairs Act, and prosthetic limbs, aids among the assistive devices for persons with disabilities under Article 65 of the Act on Welfare of Persons with Disabilities are excluded here from:
- A product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease;
- A product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment;
- A product used for the purpose of testing, replacing, or transforming a structure or function; or
- A product used for the purpose of contraception.
Classification
| Type | Risk level |
| I | Low risk |
| II | Low to moderate risk |
| III | Moderate to high risk |
| IV | High risk |
Competent Authorities and Registration Process
The main regulatory authority for all medical devices circulated in market is the Ministry of Food and Drug Safety (MFDS). For marketing authorization, the subordinate agencies are authorized to carry out licensing depending on the device classification as follows:
Options for registration applicant
Our Services
Registration service
Registration service
With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.
Marketing Authorization Holder (MAH) Service
Marketing Authorization Holder (MAH) Service
If enterprises are concerned about the cost of establishing a legal entity in South Korea or wish to avoid granting exclusive distribution rights to a local partner, MedNovum offers a flexible and optimal solution. Through our trusted partner based in South Korea, we provide MAH service, supporting enterprises in submitting registration applications as designated, while helping them maintain control over product management and market.
Regulatory Compliance Consulting Service
Regulatory Compliance Consulting Service
-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.
MEDNOVUM
YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR
HUMAN RESOURCES
MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.
ISO CERTIFICATE
Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.
NUMBER OF YEARS OF EXPERIENCE
With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.