Medical Device Registration in Korea

Medical Device Registration in KoreaKorea’s medical regulatory system can be complicated for Western medical device manufacturers due to its increasingly strict requirements and Korea’s unique business culture.

For quick, cost-effective medical product registration in Korea, count on the regulatory affairs consultants at Pacific Bridge Medical. Whether you want to sell medical devices, equipment, instruments, or supplies in Korea, we have the expertise to get the registration approval you need to bring your product to market.

For more details regarding the regulatory system and registration process in Korea, click on the questions below.

Which regulatory bodies in the Korean government are responsible for medical device registration in Korea?

  • The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), oversees the safety and efficacy of drugs and medical devices in Korea.
  • The MFDS is divided into five bureaus. The Pharmaceutical Safety Bureau and the Medical Device Safety Bureau are the two divisions holding primary responsibility for pharmaceutical and medical device regulations.

In Korea, are medical devices required to be registered before they can be sold?

Yes, medical devices do require registration prior to being sold in the market.

What are the different regulatory classifications for medical devices?

  • Class I – Low Risk
  • Class II – Medium Risk
  • Class III – Medium High Risk
  • Class IV – High Risk

What does the registration pathway look like for each regulatory classification?

If you have no local office in South Korea, you must appoint a Korea In-Country Caretaker (ICC) based in Korea to manage your medical device registration with the MFDS.

Class I

  1. Prepare Pre-Market Notification including basic device information. All documents must be in Korean.
  2. Submit Pre-Market Notification application to MFDS for Approval.
  3. Korea License Holder assists with clearing products through South Korean Customs. Pre-Market Approval/Notification license and KGMP Certificate must be presented during importation.

Most Class I medical devices are exempted from technical review and KGMP certification procedures.  The exceptions to this are Class I sterile and measuring devices, which are regulated in the same way as Class II devices.  With the Notification Listing System, Class I medical device manufacturers can complete product registration after uploading registration information onto the MFDS electronic portal.

Timeline: about 2 months

Class II, III, IV

  1. Prepare General Technical File OR Safety and Effectiveness Review (SER). Clinical data must be included in these submissions. The MFDS may accept clinical data obtained in other markets. All documents must be in Korean.
  2. Submit device for Type Testing to independent lab such as the Korea Testing Lab OR submit existing equivalent testing results.
  3. Have your General Technical File or SER Technical File reviewed by the MFDS or a Third Party Reviewer.
  4. Your company and your Korea License Holder must comply with Korea Good Manufacturing Practice (KGMP) quality system requirements. KGMP certification includes an on-site audit of foreign manufacturing facilities. KGMP certificate issued by MFDS and is valid for 3 years. KGMP certification is now required before product registration.
  5. Pre-Market Approval license is issued by MFDS and does not expire.
  6. Korea License Holder assists with clearing products through South Korean Customs. Pre-Market Approval/Notification license and KGMP Certificate must be presented during importation.

Timeline:

  • Class II Regular – 6 months
  • Class II with Safety Effectiveness Review – 15 months
  • Class III Regular – 9 months
  • Class III with Safety Effectiveness Review – 15 months
  • Class IV Regular – 9 months
  • Class IV with Safety Effectiveness Review – 15 months

What are the document requirements for registration for each regulatory classification?

Class I

  • Pre-Market Notification including basic device information (all documents must be in Korean)
  • Electronic Safety Compliance (June 2016 Compliance Deadline)

Class II

  • For Class II medical devices, pre-market approval procedures mainly depend on the device’s level of Substantial Equivalency (SE) with previously approved products.  Medical devices are divided into four categories according to the KFDA SE standards:
    1. Announced Equivalent product
    2. Equivalent product
    3. Improved product
    4. Novel product.
  • Announced Equivalent products are not subject to technical document review.  Medical devices in the other three SE categories must go through the technical documents review process.  Definitions and criteria to determine SE categories can be found in the revised Medical Device Act and on the KFDA website.

Class II, III, IV

  • General Technical File OR Safety Effectiveness Review (SER)
    • Clinical data must be included in these submissions. The MFDS may accept clinical data obtained in other markets. All documents must be in Korean.
  • KGMP Certification (Issued by the MFDS, valid for 3 years)
  • Electronic Safety Compliance Standards
    • Class II devices will have until June 2015
    • Class III and IV devices must comply with the new safety standards starting in June 2014
  • Summary Technical Documentation (STED)
    • Mandatory STED submissions for Class IV medical device registrations became effective on January 1, 2014.
    • Class IV medical devices are required to submit the STED.
    • Class I, II, and III medical devices may chose to submit the STED voluntarily.
    • For STED applications, the review timeline is expedited but the data requirements are increased.

Is local testing (type testing/sample testing) required for registration?

Local type testing for Class II, III, and IV devices may be required for registration if there are no equivalent foreign test reports. Local type testing is conducted by an independent laboratory (Korea Testing Lab is authorized to conduct type testing).

When are clinical studies required for registration?

Clinical Studies are generally not required for device registration in Korea.

Is approval in the Country of Origin required for registration?

No, approval in the Country of Origin is not required for registration in Korea.

Contact us today for a free consultation with our Korea regulatory affairs specialists.

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