The Medical Device Policy Division of the Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices` regulation, announced the enforcement of the new regulation on in vitro diagnostic (IVD) medical devices. The law No. 163433 has been initially published on April 30, 2019; and enters into force on May 1, 2020.
Basics of the IVD Regulation
The scope of the new regulation covers the most important aspects related to operations with IVD medical devices, including manufacturing or importing, to ensure that all the devices placed on the South Korean market are compliant with the applicable safety and performance requirements, and the quality of the IVD devices meets the appropriate standards.
The regulation provides the definitions of the core terms, such as “in vitro diagnostic medical equipment”, “sample”, and “clinical performance test”. It is also stated that the appropriate risk-based classification should be applied in order to establish systematic and rational safety management. All IVD medical devices should be classified in accordance with the potential risk they cause to the patient`s and public health. The particular classification rules should be set forth by the appropriate Ordinance of the Prime Minister.
MFDS Requirements on Manufacturing IVD Medical Devices
The new law on in vitro diagnostic medical devices sets forth the most important requirements related to the manufacturing of the aforementioned devices, including, inter alia, the following ones:
- Business license. The entity that is intended to manufacture IVD medical devices should have a manufacturing business license issued by the Minister of Food and Drug Safety. At the same time, in the case of manufacturing low-risk medical devices, it would be sufficient to provide the manufacturing report. In order to be eligible for obtaining a manufacturing license or filing a manufacturing report, the entity shall have all necessary facilities, as well as manufacturing and quality control systems, and to provide the MFDS with the relevant data regarding this systems, and also with the technical documents and clinical performance test data. It is also required to appoint a quality manager as a person responsible for the quality of medical devices manufactured by the company. The company applying for the license would be notified within 25 days from the day the initial application was filed. If the MFDS has not notified the applicant about granting license or assessment period extension before the expiration of the aforementioned period, the license should be deemed granted to the first day after the expiration of the initial assessment period.
- Companion Diagnostic Medical Devices. In the case of companion diagnostic medical devices, the appropriate regulations on the pharmaceutical products should be also applied, and the examination of both medicine and medical device associated thereto should be performed simultaneously.
- Clinical Performance Tests. Before conducting a clinical performance test, the manufacturer should prepare the appropriate plan. In certain cases explicitly stated in the MFDS IVD regulation, such a plan should be approved by the authority. For example, the approval will be needed if:
- The method used to collect specimens is associated with the high risk to the patient`s health,
- There is no any MFDS-cleared medical device that could be used to confirm the results of the clinical performance tests of the device in question.
- The planned clinical performance tests should be conducted with a companion diagnostic medical device.
The MFDS is entitled to cancel the planned clinical performance test or require the manufacturer to take additional measures in case if such test could potentially create additional risk to the patient`s or public health.
Clinical performance tests should be conducted by a specially designated clinical performance test institute. In order to be eligible, the institution should be properly equipped and employ healthcare professionals having the necessary qualification and experience.
IVD Changes Control in South Korea
The new regulation also introduces rules on making changes to the MFDS-approved in vitro diagnostic medical device. According to these rules, in case if the manufacturer intends to implement the changes to the device, it would be necessary to notify the authority by reporting the changes or, in certain cases, to obtain the appropriate approval from the MFDS. In particular, the following procedure should be applied:
- If the changes to be made by the manufacturer do not impact significantly the safety or performance of the device, it would be sufficient to maintain records and submit the report to the authority,
- In case if the approval is required, the authority shall respond within 15 days from the day the appropriate application has been received by the authority,
- If the authority does not provide the manufacturer with the response within the aforementioned period, the change permit (approval) shall be deemed granted on the day following the last day of the period, unless the authority explicitly notified the manufacturer on the extension.
MFDS Import Requirements
According to the regulation, the appropriate permission would be also needed to import in vitro diagnostic medical devices to South Korea. The particular procedure to be applied depends on the risk associated with the medical device in question.
- In the case of low-risk IVD medical devices, the importer shall obtain general import permission covering the model of the device.
- In all other cases, the appropriate import certification would be required for each device separately.
It is important to mention that in accordance with the new regulation, the requirements for the medical device manufacturer set forth therein should be applied for the importer too.
In-House Use IVDs
The new IVD law also provides a special regulatory framework for the in vitro diagnostic devices developed by the laboratories solely for the purpose of internal use. To be eligible for applying this procedure, the laboratory shall obtain the IVD test certification as a clinical laboratory, granted by the MFDS. The additional certification would be required in case of significant changes. When assessing the application for certification, the regulating authority evaluates the quality control system employed by the laboratory and checks whether the laboratory meets the requirements on the healthcare professionals in the terms of their qualifications and experience. The certificate issued to the laboratory equals the manufacturing or importation permit, while its scope covers only the cases of manufacturing and using devices for its own internal purposes. The certified laboratory shall also maintain compliance with all post-market surveillance requirements, including the annual inspections, record keeping, and quality management system. The authority is also entitled to revoke the certification granted to the laboratory in case of violations committed by the laboratory, such as using false or illegal methods, failing to meet applicable test certification criteria, violating compliance matters or failing to perform the corrective actions prescribed by the authority.
Summarizing the information provided hereabove, the new law on IVD medical devices enforced by the MDFS implements the main requirements medical device manufacturer shall meet in order to be allowed to place its device on the South Korean medical devices market.
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