In South Korea, the regulation of medical devices is primarily governed by the Ministry of Food and Drug Safety (MFDS). A critical component of this regulatory framework is the Korean Good Manufacturing Practices (KGMP) certification, which ensures that medical devices are manufactured in a controlled and consistent manner. This certification is mandatory for Class 2, 3, and 4 medical devices and IVDs and is essential for various stakeholders in the industry.
MFDS KGMP Regulations for Medical Devices in South Korea
The MFDS has implemented partial amendments to the Good Manufacturing Practice (GMP) Standard for Medical Devices. This amendment was published on May 12, 2023, and will take effect on November 13, 2023, six months from the date of issuance.
Who Should Apply for MFDS KGMP Certification for Medical Devices ?
KGMP Certification is required for:
Manufacturers and Importers: Those seeking to obtain a medical device manufacturing and import license or certification, or who need to make a manufacturing and import notification.
Investigational Device Manufacturers: Companies intending to manufacture or import investigational devices.
Manufacturers Seeking Audits: Medical device manufacturers or importers wanting to undergo a GMP audit or periodic audit.
Exemptions from MFDS KGMP Certification Requirements for Medical Devices
Manufacturers producing medical devices solely for export and those dealing with Class 1 devices are exempt from KGMP Certification but must still comply with MFDS GMP standards.
Types of MFDS KGMP Audits for Medical Devices in South Korea
KGMP audits can be categorized into several types, depending on the specific circumstances:
Initial Audit: Conducted for a manufacturing site that:
Is seeking recertification due to an expired GMP certificate.
Intends to manufacture for domestic sale after previously being GMP-certified for export.
Has undergone a change in legal manufacturer.
Has a change in address or intends to manufacture different product groups.
Additional Audit: For sites adding a medical device from another product group.
Modification Audit: New GMP Audit Conducted due to a change in the manufacturing site’s address.
Periodic Audit: Required every three years for each product group. Applications for periodic audits should be submitted a minimum of three months prior to the expiration of the current GMP certificate. The preferred date for the on-site inspection should be set 20 days before the expiration of the certificate's validity. If no date is specified upon application submission, the applicant must request a date in writing at least 20 days prior to the desired inspection date. Medical device manufacturers and importers with multiple manufacturing sites can submit a blanket application for periodic audits, including the required documents and a summary table of their manufacturing locations.
Who carries out assessment for compliance with MFDS KGMP Standards ?
The assessment for Korean GMP standards may be carried out by MFDS accredited Certification Body independently or Jointly with regional office of Food and Drug Safety (MFDS). Whether the assessment is carried out by Certification body independently or jointly depends of the risk classification of the medical device. Usually the Class I and Class II medical devices are assessed by certification body independently and Class III and Class IV medical devices are assessed jointly by MFDS and Certification Body.
Activity | Class | Initial Audit | Supplementary Audit | Change Audit | Periodic Audit |
Manufacturing | Class 1 | Independent | Independent | Independent | - |
Class 2 | Independent | Independent | Independent | Independent | |
Class 3 | Joint | Joint | Joint | Joint | |
Class 4 | Joint | Joint | Joint | Joint | |
Import | Class 1 | Independent | Independent | Independent | - |
Class 2 | Independent | Independent | Independent | Independent | |
Class 3 | Joint | Joint | Joint | Joint | |
Class 4 | Joint | Joint | Joint | Joint |
Determining the Product Group for KGMP Certification
The KGMP Certification is carried out for Product Group. The applicant shall refer to Annex 3 of the KGMP Standard to determine the Product Group the medical device falls into. When applying for KGMP certification, it is essential to determine the appropriate product group based on specific criteria. Here’s how to identify the product group for different types of audits:
Initial Application: If the applicant has multiple items, the focus should be on the item with the highest classification within the relevant product group of the manufacturing site.
Periodic Audit: For periodic audits, the applicant should select the item with the highest classification from the manufacturing site that has the greatest production or import volume among the items being audited.
Modification Audit: In the case of a modification audit, the item with the highest classification should be chosen from the manufacturing site that also has the highest production and import volume.
How is the assessment for compliance with MFDS KGMP Standards Carried out ?
The assessment can either be limited to a documentation review or may also include an on-site evaluation. Document reviews can be conducted in the following scenarios:
During an additional audit.
After submitting documents for a manufacturing site that has changed its address.
When another manufacturer or importer has a valid GMP certificate for the same manufacturing site.
For manufacturing sites not requiring on-site inspection when a manufacturer has multiple locations under periodic audit.
When another manufacturer or importer of in vitro diagnostic medical devices holds a valid GMP certificate for the site after an on-site inspection and document review.
On-site inspections are mandatory in these situations:
If the manufacturing site is considered potentially hazardous.
When the manufacturer or importer requests an on-site inspection due to concerns about trade secrets.
Classification | Class | Initial Audit | Supplementary Audit | Change Audit | Periodic Audit |
Manufacturing | Class 1 | On-site & document | Document | On-site & document | - |
Class 2 | On-site & document | Document | On-site, document | On-site & document | |
Class 3 | On-site & document | Document | On-site & document | On-site & document | |
Class 4 | On-site & document | Document | On-site & document | On-site & document | |
Import | Class 1 | On-site & document | Document | On-site & document | - |
Class 2 | On-site & document | Document | On-site & document | On-site & document | |
Class 3 | On-site & document | Document | On-site & document | On-site & document | |
Class 4 | On-site & document | Document | On-site & document | On-site & document |
Furthermore, manufacturers or importers that only undergo a document review must submit a test report in accordance with their quality control specifications to the Regional Office of Food and Drug Safety for each unit.
Manufacturing sites that contract in or out of the manufacturing process may also be subject to both document reviews and on-site inspections. Additionally, the manufacturing sites for convergence medical devices (including legal manufacturers) may undergo separate document reviews and on-site inspections.
MFDS Documentation Requirements for KGMP Certification
The following documents are required for KGMP certification:
Application form requesting for KGMP Certification
Business License: A copy of the medical device manufacturing (import) business license or a copy of the conditional medical device manufacturing (import) business license
Overview:
Name of the manufacturing site and addresses of all facilities (if multiple).
Organization chart and number of employees.
Medical devices manufactured.
Quality Management System GMP Certificate*:
A copy of the GMP certificate issued by the regulatory authority or an authorized institution (applicable only under Article 6 (2) or Article 6 (6)).
Due diligence data (if applicable under Article 6 (2) 2 or Article 6 (6)), including follow-up measures based on the on-site inspection results.
Facility Status:
Floor plan including work areas, laboratories, and storage (for Software as a Medical Device [SaMD], include a floor plan if applicable).
List of facilities and equipment.
Clean room procedures (if applicable) and monitoring procedures for measuring instruments.
Quality Manual: Quality manual including the quality policy of the manufacturing site.
Finished Product Testing:
Procedures and test results for finished product testing (e.g., final shipment inspection) for representative items.
Evidence of sterilization for sterilized products.
Purchasing and Contracting Procedures: Procedures and names of major suppliers (including contractors) for representative items and the scope of respective work.
Device Master Record: Device master record for representative items, including specific manufacturing processes (e.g., sterilization, software) and sterilization validation procedures (if applicable).
GMP Checklist: Annex 2 GMP Checklist for Manufacturing Site.
GMP Declaration of Compliance*: Annex 2 GMP Declaration of Compliance.
Letters of Designation*: Letters designating representative items as innovative medical devices (applicable only to innovative medical devices).
These documents must be prepared and submitted to ensure compliance with KGMP certification requirements.
MFDS KGMP Certification Process for Medical Devices in South Korea
The KGMP certification process overseen by the Ministry of Food and Drug Safety (MFDS) involves several key steps to ensure compliance with Good Manufacturing Practice standards for medical devices. Here’s a breakdown of the process:
Application Submission: The manufacturer or importer submits an application to the certification body.
Documentation Review: The certification body reviews the submitted documentation, typically taking up to 5 days.
Communication with Regional MFDS: If the auditing body is not independent, the certification body will report the findings and request confirmation from the head of the regional MFDS.
On-Site Inspection Scheduling: The regional head decides on the date for the on-site inspection and communicates this to the applicant within 10 days.
Audit Results for Documentation Review: If the process involves only a documentation review, the audit results or reports will be sent to the applicant within 30 days from the date of application.
On-Site Inspection Timeline: An on-site inspection must be conducted within 90 days from the application date.
Submission of Audit Report: For on-site audits, the audit report must be submitted within 7 days following the completion of the inspection.
By following these steps, manufacturers and importers can navigate the KGMP certification process effectively, ensuring that their products meet the required safety and quality standards.
Validity of KGMP Certificate for Medical Devices in South Korea
The KGMP certificates are generally valid for three years, with specific conditions affecting the calculation of validity based on audits and prior certifications. The validity of KGMP (Korean Good Manufacturing Practice) certificates issued by the Ministry of Food and Drug Safety (MFDS) in South Korea is as follows:
Initial Audit: The GMP certificate is valid for three years from the date of issuance.
Additional/Modification Audits: These audits do not alter the original validity period of the certificate.
Periodic Audits: The validity period is extended to three years from the day after the existing certificate's expiry date. If the new certificate is issued after the expiry date or a blanket application for a periodic audit is made, it will be valid for three years from the issuance date.
Reissuance of MFDS KGMP Certification for Medical Devices in South Korea
The Certification Holder may request a new certificate in the event of loss or specific changes, including:
Change in the name of the manufacturing or importing business.
Change in the address of the manufacturing business
Change in the address of the importing business.
Change in the name of the legal manufacturer or manufacturer.
Change in the address of the legal manufacturer or manufacturer
Mark of MFDS Korea GMP Audit Certification for Medical Devices
Manufacturers and importers of medical devices may display the GMP Audit mark for devices within the same product group as those manufactured at a site that has undergone a GMP Audit.
KGMP Certification is crucial for medical device manufacturers and importers in South Korea, particularly for Classes 2, 3, and 4. It ensures compliance with safety and quality standards, ultimately protecting public health.
For companies navigating the complexities of KGMP Certification, expert guidance is invaluable. If you need assistance with the certification process or have any questions, contact Artixio at info@artixio.com. We're here to help you succeed in the South Korean medical device market!
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