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KFDA certification refers to the domestic product production and sales license issued by Korea Food and Drug Administration (KFDA).

The Korea Food and Drug Administration (KFDA), established in 1996, is responsible for ensuring the safety of foods, medicines and other consumer goods in order to ensure the health of citizens and support the development of the food and drug industry. South Korea implements a pre-reporting system for imported foods, which allows it to grasp information on imported foods in advance and determine if it needs to carry out its first import safety assessment. Imported foods that have passed the inspection and quarantine will be allowed to import and issue import certificates; unqualified imported foods will be notified by the local FDA to the applicants and local customs, and the measures for returning, destroying, or changing the use of the foods will be taken. After imported foods enter the market, local FDA food inspection agencies and local food safety agencies will conduct random inspections in the circulation area.

Korean medical equipment market and regulatory status
The population of South Korea is about 50,000, and the medical equipment market demand has now reached more than US$3.5 billion, ranking the top 10 in the world. At present, South Korea manages medical equipment based on the Medical Device Act (MDA) developed in 2003.
The management of medical equipment is mainly managed by FKDA's Medical Device Safety Bureau (divided into MD Policy Division, MD Management Division, MD Quality Division, and three review units (Diagnostic MD Division, Therapeutic MD Division, Medical Materials Supplies Division) and two The team (Approval-Review Coordinating Task Force, In-Vitro Diagnostics Task Force) and 6 regional offices.
The following is a description of the history of Korea's medical device management reforms and the recent active reforms of medical device management measures. (KFDA was officially renamed MFDA (Ministry of Food and Drug Administration) in March 2013

1. Korea's medical equipment management reform process
The 1953-Pharmaceutical Act PHA (Pharmaceutical Affairs Act) defines medical devices,
- Importing manufacturer's licenses and products' certification system.
1997-Introduction of medical equipment based on risk management principles grading system - divided into 3 levels,
- Implementing the GMP system of medical equipment quality management system.
-Introduction of medical equipment product registration two-track system - registration and approval
The 2004-Medical Device Act took effect and began to be implemented under the MDA
- Change the product rating to 4 levels
- Began to manage the rental of imported medical equipment, medical equipment and medical equipment
- Import post-market monitoring system, including product reassessment and re-examination system
2007 - Mandatory KGMP/GIP compliance requirements
 
2. Introduction to Korean Medical Device Management Regulations
2.1 KiFDA-Electronic File Delivery System - Pre-market registration information and post-marketing notification materials for electronic submissions are self-developed website delivery systems for KFDA, with the following key points:
- Accepts pdf, jpg, hwp and word documents
- Almost every kind of application can be delivered
Pre-marketing data delivery
• Manufacturing/Importer License Application
• Product manufacturing/import license application
• Product Registration Application
• Product Technical File Review Application
• Clinical trial program review application
• Clinical trial agency approves application
Post-marketing data delivery
• Clinical trial notification
• Notification of side effects
• Recycling or delisting (voluntary or mandatory)
• Safety Information Bulletin
• Check the notification again
• Reassess the notification
• Notification of production or import volume
2.2 KFDA Audit Executes Qualification of Clinical Equipment Clinical Trial Center
• To ensure the right number of patients and the quality of clinical trials performed, hospitals and physicians performing clinical trials of medical devices must be approved by KFDA.
• The hospital performing the trial must have a SOP that complies with the GCP. The physician performing the trial must be trained in medical device development and GCP.
• More than 94 university hospitals have been registered as medical device clinical trial centers.
2.3 Medical Device Tracking
• The principle of inclusion of trace items for medical devices
1) Implanted in the human body and left for more than 1 year
2) Medical equipment used outside of medical institutions for life support
• The currently listed medical device items are as follows:
1) Implantable pacemakers
2) Electrodes for implantable pacemaker or defibrillators
3) Artificial heart valves
4) Defibrillators
5) Implantable infusion pumps
6) Artificial Ventilators
7) Breast implants (silicon gel)
2.4 Recall or Recall
• Responsibility of the manufacturer or importer for recycling or off-shelf
• Recall is divided into 3 levels by risk
1) Class 1: Use of medical equipment leads to irreversible side effects or death
2) Class 2: Use of medical equipment causes temporary side effects and can be treated
3) Class 3: Medical equipment does not comply with the standard specifications specified in Article 18 of the Medical Device Act. Although it is infringed, it does not cause danger or side effects.
4) The Recall action plan must be sent to KFDA headquarters. After confirmation, Class 1 must be completed within 5 days. Class 2 and Class 3 must be completed within 15 days.
2.5 Adverse Event Reporting
• Manufacturers, distributors, service providers, leasing companies, hospitals/clinics and animal clinics have reporting duties
• The incident must be notified
1) Death or life-threatening events related to medical devices
2) Lead to serious side effects - resulting in extended hospital stay, irreversible injury, severe disability or reduced function, loss of consciousness or abnormality
• Notification of death or life-threatening side effects
1) The key notification is completed within 7 days
2) Other supplementary details are completed within 8 days
• Notifications that cause serious side effects
1) The key notification is completed within 15 days
2) Other side effects are reported within 30 days
2.6 Quality Management System Regulations
• Based on -Enforcement Regulation of the Medical Device Act
• Manufacturers are required to comply with “Standards for manufacturing and quality management of medical devices (similar to ISO 13485)
• Importers are required to comply with "Standards for import and quality management of medical devices"
• The review and check of the above two quality systems are performed by four agency agencies (KTL, KTR, KCL and KTC)
• Update once every 3 years
2.7 Product Review Process
• General technical file review
1) Substantially equal to the products that have been listed
2) No clinical trial report required
• Technical review with safety and efficacy
1) Mainly for new development, new efficiency, new structure or new usage
2) People with major differences in safety and efficacy
3) Clinical research report must be attached
2.8 Review procedures classified as Class 2, 3 or 4 medical devices
• Deliver application to KFDA headquarters
• Each product model and code number must also be submitted
• KFDA headquarters review technical file application
• Optional technical file and product registration application together
• Or choose to send technical file review and re-send product registration application first
2.9 Class 1 medical equipment currently registered for registration
• There is no need to send extra paper to the first grade medical equipment for online registration.
• Does not accept non-medical equipment applications
• Does not accept applications for medical device products that require pre-market review approval
2.10 Applying for a Medical Device License
• Must apply to KFDA Regional Office (with 6 regional offices)
• Application documents to be attached
1) Medical certificate of representative of business party issued by physician.
2) Corporate register
• GMP/GIP certification must be attached
• New Medical Device Factory must apply for a medical device license when applying for a product certificate
• The applicant fills in Form No.2 after filling in Form No.1 and passing KFDA review and approval.
• Generally completed within 25 days
2.11 Entrust third verification authority to conduct product technical review business
• 100 second-level products have been commissioned by the third verification authority for product technical review in 2011
• In the second phase, 300 second-class technical reviews of second-level medical device items will be released
• Out-of-commitment technical review of final target second-level medical equipment items

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KFDA認證是指韓國食品藥品管理局(KFDA)頒發的境內產品生產和銷售許可證。

成立于1996年的韓國食品藥品監督管理局(KFDA)，其職責是保障食品、藥品等消費品的安全，以此來確保公民健康，並支持食品藥品行業的發展。韓國對進口食品實施預申報制度，可以提前掌握進口食品相關資訊，判定其是否需進行首次進口安全性評估。經檢驗檢疫合格的進口食品，將允許進口並簽發進口證書；不合格的進口食品將由地方FDA通知申請者和地方海關，並對該批食品採取退運、銷毀或改變用途等處理措施。進口食品進入市場後，地方FDA食品監察機構和地方食品安全機構還將在流通領域進行隨機檢查。

韓國醫療器材市場及管理法規現況
韓國人口數約5仟萬，醫療器材市場需求目前已達到35億美元以上，居全球前10大。 目前韓國管理醫療器材是依據2003年研擬制定的醫療器材法MDA (Medical Device Act)。
醫療器材的管理主要由FKDA的Medical Device Safety Bureau (轄下分為MD Policy Division、MD Management Division、 MD Quality Division 及3個審核單位 (Diagnostic MD Division、 Therapeutic MD Division、 Medical Materials Supplies Division)及兩個小組(Approval-Review Coordinating Task Force、 In-Vitro Diagnostics Task Force)) 及6個區域辦公室。
以下分別說明韓國醫療器材管理改革的歷程及最近積極改革的醫療器材管理措施。 (KFDA於2013年3月正式改名為MFDA (Ministry of Food and Drug Administration)

1.    韓國醫療器材管理改革歷程
1953-藥事法PHA (Pharmaceutical Affairs Act)內定義醫療器材,
-導入製造廠許可證及產品可哥證制度。
1997-導入醫療器材基於風險管理原則分級制度-分為3等級,
-執行醫療器材品質管理系統GMP制度。
-導入醫療器材產品註冊兩軌制-登錄 (notification)及審查(approval)
2004-醫療器材法生效並開始依MDA執行
-改變產品分級為4等級
-開始管理進口醫療器材、中古醫療器材及醫療器材租賃業
-導入上市後監管系統，包括產品再評估及再審查系統
2007-強制要求KGMP/GIP法規符合性
 
2.    韓國醫療器材管理法規概論
2.1  KiFDA-電子檔案送件系統-可電子送件上市前註冊資料及上市後通報資料,為KFDA自行開發的網站送件系統,主要重點如下:
-可接受pdf, jpg, hwp及word檔送件
-幾乎每種申請案皆可送件
上市前的資料遞送
•    製造/進口商許可證申請
•    產品製造/進口許可證申請
•    產品登錄申請
•    產品技術檔案審查申請
•    臨床試驗計畫書審查申請
•    臨床試驗機構核可申請
上市後的資料遞送
•    臨床試驗通報
•    副作用通報
•    回收或下架通報 (自願性或強制性)
•    安全資訊通報
•    再檢查通報
•    再評估通報
•    生產量或進口量的通報
2.2 KFDA審核執行醫療器材臨床試驗中心資格
•    為確保合適的病人數與執行臨床試驗的品質，執行醫療器材臨床試驗的醫院與醫師須經KFDA認可。
•    執行試驗的醫院須有符合GCP的SOP，執行試驗的醫師必須接受醫療器材開發及GCP的訓練。
•    到目前已有超過94家大學醫院登記為醫療器材臨床試驗中心。
2.3 醫療器材追蹤 (Medical Device Tracking)
•列入醫療器材追蹤品項的原則
1)      植入於人體內並留置超過1年
2)      使用於醫療機構外使用於維持生命的醫療用具
•目前列入追蹤的醫療器材品項如下:
1)      Implantable pacemakers
2)      Electrodes for implantable pacemaker or defibrillators
3)      Artificial heart valves
4)      Defibrillators
5)      Implantable infusion pumps
6)      Artificial Ventilators
7)      Breast implants (silicon gel)
2.4 回收或下架 (Recall)
•      製造廠或進口商負責回收或下架的責任
•      Recall依風險分3個等級
1)      Class 1:使用醫療器材導致無法治療的嚴重副作用或死亡
2)      Class 2:使用醫療器材導致暫時的副作用且可治療
3)      Class 3:醫療器材不符合醫療器材法Article18規定的標準規格，雖違反但不會產生危險或副作用
4)      Recall行動方案須送交KFDA總部，經確認後Class 1須5日內完成，Class 2及Class 3須15日內完成
2.5 副作用通報 (Adverse Event Reporting)
•      製造廠、分銷商、維修業者、租賃業者、醫院/診所及動物診所有通報義務
•      須通報事件
1)      與醫療器材相關的死亡或威脅生命的事件
2)      導致嚴重副作用-造成住院日期延長、不可逆傷害、嚴重失能或功能降低、知覺喪失或不正常
•      死亡或威脅生命的副作用通報
1)      關鍵通報於7日內完成
2)      其他補充細節於8日內完成
•      導致嚴重副作用的通報
1)      關鍵通報於15日內完成
2)      其他副作用通報於30日內完成
2.6 品質管理系統法規
•      依據-Enforcement Regulation of the Medical Device Act
•      製造廠依要求須符合 “Standards for manufacturing and quality management of medical devices (與ISO 13485類似)
•      進口商依要求須符合 “Standards for import and quality management of medical devices”
•      上述兩項品質系統的審查與查核由4家代施查合機構執行 (KTL、 KTR、 KCL及 KTC)
•      每3年更新1次
2.7 產品審查流程
•    一般技術檔案審查
1)      與已通過上市的產品作實質相等性比對
2)      不須臨床試驗報告
•    具安全性與療效性的技術審查
1)      主要為新開發、新效能、新結構或新使用途徑
2)      會影響安全性及療效性具重大差異性者
3)      須檢附臨床研究報告
2.8  歸類為第2、3或4等級醫療器材的審查程式
•    遞送申請案到KFDA總部
•    每個產品model及code number也須繳交說明
•    KFDA總部審查技術檔案申請
•    可選擇技術檔案及產品註冊申請一併送件
•    或選擇先送技術檔案審查再送產品註冊申請件
2.9  歸類為第1等級醫療器材目前以登錄備查即可
•    第1等級醫療器材以線上登錄資料不須再額外送紙本
•    不接受非醫療器材申請
•    不接受須上市前審查批准的醫療器材產品申請
2.10           申請醫療器材商許可證
•    須向KFDA區域辦公室申請 (有6個區域辦公室)
•    須檢附的申請文件
1)      Medical certificate of representative of business party issued by physician.
2)      Corporate register
•    須檢附GMP/GIP證明
•    新醫療器材廠申請產品證時須檢附醫療器材商許可證
•    申請者填寫繳交Form No.1 經KFDA審核通過後核給Form No.2
•    一般25日內可辦理完成
2.11           委託第三驗證機關辦理產品技術審查業務
•    2011年已開放100項第2等級產品委託第三驗證機關辦理產品技術審查
•    第二階段將再開放第二等級醫療器材品項300項委外技術審查
•    最終目標第二等級醫療器材品項全部委外技術審查