In order to export medical devices to Korea, a foreign manufacturer must designate an official importer of medical devices located in Korea (the "Importer") and require the Importer to obtain three separate licenses (Business, Product, and KGMP certification). In addition, in order for a medical device to be exported to Korea, a domestic importer must obtain a KMDIA Prior Report on Customs Clearance before filing an import declaration with the Korea Customs Service ("KCS") by providing the KMDIA Prior Report to the customs clearing agency.
In summary, in order to export medical devices to Korea, the official importer must obtain the three licenses listed above in addition to preparing the KMDIA Prior Report. In light the the K-GMP certification requirement, the Ministry of Food and Drug Safety (the "MFDS") recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)" to specify K-GMP review methods, which had been unclear, and to standardize certification procedures. Main items to note are as follows:
1. Subject and Scope of KGMP Review
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In principle, "document review and on-site review" shall both be conducted for each overseas manufacturing site.
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The Proposed Amendment classifies the products manufactured by the manufacturing facility into 26 KGMP product groups, and requires that any products that fall under a new product group undergo additional KGMP certification product group review.
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In case of a change in the location of the manufacturing site, an amended KGMP review will be required.
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After the initial KGMP review, the KGMP request for renewal review will be required every three years.
For reference, in the case of SaMD, although there is no manufacturing process, the quality policy/design management/contract review/customer complaint and side effects report/CAPA will be reviewed during the on-site inspection for K-GMP certification.
2. Inspection Period and Audit Personnel for KGMP Certification
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The KGMP review period is 30 days, and the subsequent results will be classified as "conforming/non-conforming/requires supplementation."
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KGMP's initial/renewal inspections will require "documents + on-site" for initial KGMP certification, and for "additions/amendments" are only "documents" inspection will be required
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Inspecting agencies will differ depending on the class of medical devices manufactured at the manufacturing site(s)
* Class 1: Exemption from review
* Class 2: Independent inspection by third-party inspection agencies (four institutions in Korea; KTL/KTC/KTR/KCL)
* Classes 3 to 4: Joint review by third-party inspection agencies and the MFDS
3. Examples of KGMP Non-Compliance
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Quality-related processes (e.g., quality policy, contract review, design management, document and data management, etc.) required by the Korean Medical Devices Act are not documented.
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Quality control has not been performed in accordance with the documented process;
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Information to be provided to the domestic importer (e.g., whether the product has changed) has not been identified or has not been actually delivered to the importer
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Quality records have not been retained and tracked for more than 5 years as of the time of product release.
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If the measuring instrument is not inspected or calibrated, or if the "validation" of the manufacturing process that requires "validation" has not been conducted
4. Temporary suspension of on-site KGMP inspection
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If it is impossible to conduct an on-site inspection due to a war, an infectious disease (e.g., COVID-19), or a natural disaster, the on-site audit will be postponed and only the document audit will be conducted. However, whenever a product is imported, a quality test report per Lot/Batch Number must be submitted to the MFDS for approval for release.
As a reference, in the event of KGMP non-compliance, administrative sanctions can be issued depending on the type of KGMP inspection that was conducted previously. If non-conformity is identified during initial KGMP review, the non-conforming issue must be corrected and the applicant must re-apply for KGMP certification. On the other hand, in case of review for KGMP renewal/addition/amendment, an import ban/administrative sanction and criminal referral against a domestic importer and even a recall order for products that are not conforming to KGMP requirements can be issued.
If you or your company is interested in entering the Korean market and thus preparing for the KGMP review, please refer to the points above. If you have any questions regarding KGMP review in Korea, please contact MDREX(pro@mdrex.co.kr) and we can assist in KGMP certification matters for you or your client(s).
#MedicalDevice, #KGMP, #ISO13485