Medical Device Registration and Approval in South Korea

In order to register your medical device for sale in South Korea, you must first obtain approval for your product from the Ministry of Food and Drug Safety, which is governed by the Office of the Prime Minister. 

ANSWERED ON THIS PAGE: 

• What are the key medical device regulations in South Korea? 
• Is local testing required in South Korea? 
• Do foreign manufacturers need an in-country representative? 

South Korea is a rapidly growing market for medical devices, with an advanced healthcare system ranked as one of the best in the world. Navigating the regulatory landscape can be complex, so it is important for manufacturers to understand the requirements for gaining market access. Emergo by UL has the expertise and resources to help you secure regulatory approval in one of the most significant medical device markets in Asia. 

Medical device regulations and classification in South Korea 

Medical devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS). The legal framework for the regulatory system is based on the Medical Devices Act, the Enforcement Decree of the Medical Devices Act, and the Enforcement Regulations of the Medical Devices Act. There are three types of market authorizations granted by the MFDS. A Pre-Market Notification is required for medical devices with minimal potential risks. Higher risk classes require either a Pre-Market Certification or Pre-Market Approval. 

The requirements for regulatory approval in Korea include both a device approval as well as a quality system certification, known as Korea Good Manufacturing Practices (KGMP), specified in the Medical Device Manufacturing and Quality Control Standards (similar to ISO 13485:2016).  

The MFDS uses a four-tiered classification system based on risk to the human body, with increasing risk assigned to Classes 1, 2, 3, and 4, respectively. Increasing regulatory requirements correspond to increasing risk. The classification system is similar to the classification system in the U.S. in that it individually assigns a classification to each device type and it follows a predicate system. 

Manufacturers of Class 2, 3, and 4 devices must receive K-GMP Certification prior to issuance of the device registration. Additionally, almost all Class 2-4 devices require supplementary testing to Korean product standards as part of the registration. 

South Korea testing requirements 

The MFDS has local product standards and performance testing requirements in addition to the internationally recognized test standards. If existing test reports do not meet Korean requirements, additional testing in South Korea may be required. The testing does not necessarily have to be conducted in South Korea, though from a practical standpoint, it may be difficult to find a laboratory outside of South Korea that will test to the Korean requirements.

Emergo can fully support your medical device registration in South Korea. 

With an office in Seoul, Emergo is equipped to help you achieve regulatory compliance and start selling your medical device in this market. Here's how we can help: 

• Identify your device classification and appropriate registration route. 
• Act as your in-country representative and liaise with authorities throughout the registration process. 
• Assist with technical dossier preparation and KGMP application. 
• Advise on optimal grouping strategy to minimize registrations and associated costs. 
• Assist with post-market surveillance, vigilance and adverse-event reporting, if needed. 

Emergo is a full-service regulatory consulting firm that specializes in the global medical device industry. Your success in South Korea is our priority. 

Common questions regarding medical device registration in South Korea 

Do I need to compile the technical dossier in Korean? 
The Technical File application must be submitted in Korean, but foreign data in English is generally acceptable for submission. Data in foreign languages other than English shall be submitted with a notarized translation of the entire text. 

What is the quality management system (QMS) requirement in South Korea? 
Manufacturers of devices other than Class 1 must submit quality system documentation and receive certification to K-GMP as part of the medical device registration process. K-GMP is harmonized to ISO 13485:2016 and is specific to the manufacturing site and local applicant/importer.  

Class 2 device manufacturers are generally inspected by an authorized Third-Party Auditor (TPA), although the MFDS reserves the right to participate in the inspection. Class 3 and 4 device manufacturers are inspected by a TPA and by the MFDS. It is possible, depending upon the circumstances, for the on-site audit(s) to be waived in favor of a desktop. 

Is home-country approval required? 
No, approval in your country of origin is not required. There is currently also no route through which an existing approval in another market may be leveraged in South Korea.