This page talks about the overall process of registration in South Korea by MFDS
Korean Medical Device Market
Over 60% of medical devices used in Korea are imported. With a population of 50 million, where people are growing older with average income per capita on the rise, Korea represents an attractive destination for medical device manufacturers. Korea is expected to be in the top 7 countries in the medical device space by 2020 and manufactures worldwide are targeting this market presently. Korea is the third largest medical device market in Asia with a CAGR of 13.5% and a market value of $3.9 billion in 2012.
Korea Medical Device Regulation
In 1953 the Pharmaceutical Affairs Act first defined medical devices and defined a regulatory framework for product approvals. In 1997, the three phase classification system and regulations for good manufacturing practices (GMP) was introduced. The preliminary act evolved to the Medical Device Act in 2004 to re-define the classification system as four types (little risk, low risk, medium risk, high risk; see below).
Under law, a foreign manufacturer must have local office in Korea or legally appoint a importer or third party regulatory agent to maintain importing flexibility. Additionally it is important to remember that the manufacturer MUST SELL IN COUNTRY OF ORIGIN to apply for product license in Korea.
The main steps for product approval by Korea’s Ministry of Food and Drug Safety (MFDS) are:
Step 1: Appointing a license holder/ distributor under whose name the application for product approval will be made
Step 2: Having the medical device tested at the MFDS verified laboratories
Step 3: Submission of the technical file to the MFDS designated agent for Class II devices or to the MFDS directly for Class III or Class IV devices
Step 4: Post- approval inspections following which you can commercialize the device in Korea
Device Types & Classifications
There are three main device types and 4 classification systems by the Korean MFDS.
Product Types as per Korea MFDS:
New product: When the medical device is NOT EQUIVALENT to any approved medical device in IFU, material of construction, and other product specifications.
Improved product: When the medical device is EQUIVALENT to approved medical device in material of construction, purpose of usage or working mechanism and DIFFERENT in IFU, performance etc.
Equivalent product: When the medical device is EQUIVALENT to approved medical device in material of construction, purpose of usage, working mechanism, IFU, performance etc
Product Classifications as per Korea MFDS
- Class I: medical devices with little potential risk
- Class II: medical devices with low potential
- Class III: medical devices with medium serious potential risk
- Class IV: medical devices with high risk
Three key processes are required for product registration with the Korea MFDS:
- Product License – permanent
- Korean Good Manufacturing Practice (KGMP) Certificate – has to be renewed every three years
- Device Business License – permanent
On obtaining the above three licenses it is legal to market the medical device in Korea. However, other important processes, which must be full-filled, include reimbursements and post-market surveillance.
1. Product License
1a. Class I
Manufacturers can obtain regulatory approval directly via the online approval system which will generate the Certificate of Medical Device Notification. The applicant must submit the essential information of the Class 1 device including IFU, material of construction, product specifications, labeling etc.
1b. Classes II-IV
The two main requirements for Classes II, III and IV devices are a technical file and type testing.
For ‘improved’ and ‘equivalent’ products a general technical file (GTF) is sufficient and for ‘novel’ products a safety and effectiveness review (SER) technical file is required. The GTF is similar to the information required for Class I online notification with additional information on safety, biocompatibility, design testing etc. They can be reviewed by a third party organization and general time frame is 1 month.
The SER technical file requires clinical study reports. The KFDA accepts foreign trials as long as they have been published in reputed medical journals and accepted in the country of manufacturing. They must be reviewed by the KFDA and general time frame is 2-3 months.
Samples and technical file must be submitted to a third party testing lab that will provide a certificate of validation. The process takes 1-4 months with fees ranging from US $2500 – US $10,000. 0, all depending on the type of device. At the completion of testing, the lab will issue a certificate of compliance. Alternatively, test results that meet international standards, previously done in other countries can be used and validated at a fee of about US $700.
2. Device Business License
Generally the local importer in Korea will have this license for other products that can be used in this case. It is obtained by submitting one Product License and relevant company information.
3. KGMP Certification
The KGMP standard is similar to ISO 13485. Process takes about 1 month and the certificate is valid for 3 years. The local Korean partner has to undergo this process via a third party organization.