Class Ⅰ & Ⅱ devices are certified by 'Medical Device Information and Technology Assistance Center(MDITAC)' and some Class Ⅱ(new devices) and Class Ⅲ & Ⅳ devices are approved by .
※ MDITAC, established by , conducts the business affairs related to certification of medical devices and provides the information and technical support regarding medical devices, including researches on international specifications for improving technologies for medical devices, gathering, analysis, and management of information from domestic and overseas sources
Modified Device is a medical device that is equivalent in the purpose of use, working mechanism, raw materials (Limited to medical supplies) with the already approved medical device, but not equivalent in performance, test specifications, instructions for use, etc.
Ministry Of Food And Drug Safety
SE Device is a medical device that is equivalent in the purpose of use, working mechanism, raw materials(Limited to medical supplies), performance, test specifications and instructions for use with the already approved medical device. Recognized SE Device is a recognized medical device that is equivalent in the purpose of use, working mechanism, and so on defined by .
New(novel) Devices is a medical device that is not equivalent in the purpose of use, working mechanism or raw materials (Limited to medical supplies) etc. with the already approved medical device.
Requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business license respectively.
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As an applicant has to possess at least one product license in order to obtain a business license, approval processes of a business license and a product license are conducted contemporaneously.
52 medical device items are designated as the medical devices subject to tracking and control, which need to be traceable, as they can cause fatal harm to a human body when an adverse event, or a defection occurs while using them. - 48 items that are implanted into a human body for over one year - Four (4) life-sustaining items that can be used in places other than medical facilities
B. Quantity of product sales by model and manufacturing unit, date of sale, and trade name or address of a person who established a medical institution
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A. Quantity of product sales by model and manufacturing unit, date of sale, and trade name or address of a person who established a medical institutionIn principle, Class I & II devices are certified by ‘Medical Device Information and Technology Assistance Center(MDITAC) the ‘National Institute of Medical Device Safety Information (NIDS) and Class III & IV devices are approved by . However, Class I & II devices in categories below must be approved by .
IVD reagents for diagnosis of HIV/HBV/HCV/HTLV(immunological method), IVD reagents for ABO〮RhD blood typing(red cell agglutination), IVD reagents for diagnosis of HVI/HBV/HCV/HTLV(molecular diagnostics), etc.
※NIDS is established pursuant to Article 42 of the Medical Device Act and has been entrusted with tasks related to the notification and certification of medical devices under Paragraph 2 of Article 44 of the Act by the Minister of Food and Drug Safety.
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“SE Device” is a medical device(or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action(MoA)’, ‘Raw Materials, ‘Performance’, ’Test Specification’(not applicable to IVD), ‘Instructions for Use’(not applicable to IVD) with previously approved/certified/notified medical devices. ※ For medical devices in Class II that were approved and certified for more than three times with the equivalent product, may publicly announce those as a ‘Recognized Substantial Equivalent(SE) devices’,
“Modified Device” is a medical device(or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action(MoA)’, ‘Raw Materials(Limited to implanted/contacted devices & most of devices are not intended to operate electrically, not applicable to IVD)’ with previously approved/certified/notified medical devices, but not equivalent in ‘Raw Materials’(only applicable to IVD) ‘Performance’, ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD).
“New(novel) Devices” a medical device(or an IVD) that is not equivalent in ‘Intended Use’, ‘Mechanism of Action(MoA)’, ‘Raw Materials’(not applicable to IVD) with previously approved/certified/notified medical devices.
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Requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business license respectively.
As an applicant has to possess at least one product license in order to obtain a business license, approval processes of a business license and a product license are conducted contemporaneously.
52 medical device items are designated as the medical devices subject to tracking and control, which need to be traceable, as they can cause fatal harm to a human body when an adverse event, or a defection occurs while using them. - 48 items that are implanted into a human body for over one year - Four (4) life-sustaining items that can be used in places other than medical facilities
Medical Device Registration And Approval In South Korea
A. Quantity and date of manufacture/import by product name (or product group title if there is no product name)/model name/batch (applicable to manufacturers and importers only)
B. Quantity and date of sale/lease, name and address of seller/lessor or founder of a medical institution by product name (or product group title if there is no product name)/model name/batch (not applicable to repairers)
A. Quantity and date of sale/lease, name and address of seller/lessor or founder of a medical institution by product name (or product group title if there is no product name)/model name/batch (not applicable to repairers)
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A. Date of repair, and name and address of client by product name (or product group title if there is no product name)/model name/batch (applicable to repairers only)TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
This process chart illustrates the MFDS approval process per device classification in South Korea and is available for download in the Regulatory Affairs Management Suite (RAMS).
All companies planning to sell a medical or in vitro diagnostic (IVD) device in South Korea must register their product with the Ministry of Food and Drug Safety (MFDS). There are three market authorization pathways, depending on the device classification. Additionally, all devices without a substantially equivalent predicate device in South Korea require clinical data review as part of the registration process.
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The chart illustrates the MFDS approval process per device classification in South Korea and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here.
Unless your device is in the lowest risk classification, submit an application for Korean Good Manufacturing Practices (K-GMP) certification to an authorized Third Party Auditor and send your device to South Korea for any required testing (or to a laboratory outside of South Korea that can test to the MFDS requirements).
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for South Korea when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.
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