韓國醫療器材登記法規問題集
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HLF-TW-10
請問韓國對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of health food in Korea? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
韓國食品藥品安全部將醫療器材進行定義和分類，單獨或組合用於人或動物的任何儀器/機器/裝置/材料或其他類似產品，但不包含藥品、準藥品，及殘疾人輔具中的假肢/輔具，醫療器材分為以下類別:
1. 以診斷/治療/緩解/治療或預防疾病為目的之產品。
2. 以診斷/治療/減輕/補充損傷或損害為目的之產品。
3. 用於測試/替換/修改生理功能之產品。
4. 用於避孕目的之產品。
韓國的醫療器材依據風險增加分為 I 、II 、III 、 IV 類，與GHTF/IMDRF 規則一致。
風險等級I 、 II 類由美國國家醫療設備安全信息研究所的醫療器材信息和技術援助中心認證，III、 IV 類由韓國食品藥物安全部批准。
但以下類別的 I、 II 類設備必須獲得韓國食品藥物安全部批准：
1.需要臨床測試報告。
2.與數位醫療相關的（例如遠距醫療系統）。
3.尚未被定義及分類。
4.與藥品結合。
上市前批准流程
．I類(通知)：須向韓國醫療器材信息與技術支持中心提出自我宣告。
．II 類(認證、批准)：需通過韓國醫療器材信息與技術支持中心認證，新器材需通過國家食品藥品安全研究所（韓國食品藥品安全部的附屬機構）批准。
．III、IV 類(批准)：需通過國家食品藥品安全研究所的批准。
網頁：https://www.mfds.go.kr/eng/wpge/m_39/de011026l001.do
The Minister of Food and Drug Safety shall classify and designate medical devices.”Medical device”, as referred to in this Act, shall mean any instrument/machine/device/material or other similar product, used alone or in combination, for human beings or animals, as specified in any of the following Subparagraph:
provided that drugs and quasi-drugs, as defined in the Pharmaceutical Affairs Act, and prosthetic limbs/aids among the assistive devices for persons with disabilities, as defined in the Act on Welfare of Persons with Disabilities Article 65, are excluded here from
1. A product used for the purpose of diagnosis/cure/alleviation/treatment or prevention of disease
2. A product used for the purpose of diagnosis/cure/alleviation or supplement of injury or impairment
3. A product used for the purpose of test/replacement or modification of anatomy or physiologic function
4. A product used for the purpose of contraception
Medical devices in Korea are classified as Class I, Class II, Class III or Class IV based on increased risk, harmonized with GHTF/IMDRF rules.
MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.
In 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 MFDS.
However, Class I & II devices in categories below must be approved by MFDS:
1. Which requires clinical test reports.
2. Digital Healthcare related. (ex. telemedicine system)
3. Undefined Nomenclature & classification regulation
4. Combined with pharmaceuticals, etc.
Premarket approval process
．Class I (Notification): Notification to Medical Device Information & Technology Assistant Center(MDITAC).
．Class II (Certification, Approval): Certified by Medical Device Information & Technology Assistant Center(MDITAC). New devices approval by the National institute of food & drug safety (affiliated agency of MFDS).
．Class III, IV (Approval): Approval by the national institute of food & drug safety
【參考連結】
https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69729&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3
https://www.mfds.go.kr/eng/wpge/m_39/de011026l001.do
HLF-TW-20
外國公司要到韓國銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell health food in Korea, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from the local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要。
醫療器材進口商應取得食品藥品安全部核發的醫療器材製造及進口業務批准：
- 申請人(負責人)：
- 姓名(韓文、中文)
- 公司註冊號或居民註冊號
- 註冊地址
- 進口商：
- 公司名稱(商業名稱)
- 地址
- 品管經理：
- 姓名
- 生日
- 資格類別
A person seeking to engage in a business of importing medical devices shall obtain an import business license from the Minister of Food and Drug Safety:
．Applicant(Representative):
1. Name (Korean、Chinese)
2. Corporate Registration No. or Resident Registration No.
3. Place of Registration.
．Importer:
1. Company Name (Business Name)
2. Address
．Quality Manager:
1. Name
2. Date of Birth
3. Classification of Qualification
HLF-TW-25
HLF-TW-30
外國公司要到韓國銷售醫療器材，可以指派韓國公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell health food in Korea, can it assign a Korean company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
需要。在韓國沒有辦事處的外國進口商不得向食品藥物安全部提交醫療器材申請，可以指定韓國許可證持有人來協調醫療器材在食品藥品安全部的申請。
韓國許可證持有人需要在韓國有註冊營業地的公司，及一位全職的品管經理，負責協助通過韓國海關清關產品、進口時的許可證和 KGMP 證書，在發生不良事件、召回時與食品藥物安全部溝通，以及在召回的情況下與製造商通知、溝通。
欲取得進口醫療器材營業許可的申請人，應向食品藥品安全部地區分局負責人提出申請:醫療器材製造/進口業務批准申請書(含電子申請書)、產品製造/進口認證申請、製造/進口通知申請報告。
Foreign importers without an office in South Korea are not allowed to submit medical device registrations to the MFDS.
Companies without a physical location in South Korea must appoint a Korea License Holder to coordinate the registration of their medical device with the Ministry of Food and Drug Safety (MFDS).
To become a license holder, a company needs a registered place of business in Korea.
It is also required to have a quality manager as a full-time employee. KLH assists with clearing products through Korea Customs, importing licenses and KGMP certificates, communicating with MFDS in the event of adverse events, recalls, and communicating and notifying manufacturers in case of recalls.
A party seeking a license to import medical devices for business shall submit to the head of the concerned regional branch of the Ministry of Food and Drug Safety an application: Application for Approval of Medical Device Manufacturing (Import) Business (including an electronic application form), Application for Product Manufacturing (Import) Certification, Application for Manufacturing (Import) Notification Report.
https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69735
HLF-TW-35
HLF-TW-40
外國公司銷售到韓國醫療器材本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文除了韓文外，其他哪種語文也可以？網頁？
Do foreign companies need to apply for an approval before importing health food sold to Korea?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? In addition to Korean, which other languages are allowed? Website?
Evershine RD：
需要。進口醫療器材產品認證的申請人，應向醫療器材信息與技術支持中心提交產品製造/進口認證申請書（含電子申請表）及製造/進口通知申請（含電子申請表）。
產品製造/進口認證申請
- 申請人(負責人) ：
- 姓名
- 生日
- 地址。
- 進口商：
- 公司名稱(商業名稱)
- 營業執照號
- 地址。
- 產品：
- 名稱（產品名稱、項目名稱和型號名稱）
- 分類號
- 外觀與結構
- 原料
- 製造方法
- 性能
- 使用目的
- 使用方法
- 使用注意事項
- 包裝單位
- 儲存方法和保存期限
- 測試規範
- 製造現場（所有進口或製造過程）等。
- 申請流程：填寫申請→提交→審查→批准→準備證書→頒發證書
製造/進口通知申請
- 申請人(負責人) ：
- 姓名
- 生日
- 地址。
- 進口商：
- 公司名稱(商業名稱)
- 營業執照號
- 地址。
- 產品：
- 名稱（產品名稱、項目名稱和型號名稱）
- 分類號
- 外觀與結構
- 性能
- 使用目的
- 使用方法
- 使用注意事項
- 製造現場（所有進口或製造過程）
- 備註。
- 申請流程：填寫宣告清單→提交→在食品藥品安全部電子政務系統註冊
醫療器材包裝內容及標示
標籤方法：於容器、包裝、外容器、外包裝或包裝說明書上，依下列各款規定進行標示。
1. 所有標籤均應為韓文或韓國漢字。
2. 字體大小、間距和其他細節應遵循食品藥品安全部規定。
3. 在醫療器材的容器、包裝或外包裝上印刷產品名稱、製造商或進口商等時，必要時可以使用點字。
容器的標籤：即使容器或包裝太小以致於不能附有全部資料，且外容器/外包裝/說明書上已經印有標籤者，也應在設備的容器或包裝上載明型號名稱、製造商或進口商的名稱。
說明書的內容：
1.法令規定之臨床試驗內容。
2.產品的預期用途。
3.儲存方法。
4. 完全由國內製造商分包生產的產品，應註明法定製造商（發貨人）和製造商（收貨人）的名稱和地址。
5.成捆包裝的單件產品，在最小包裝單位上應標明型號名稱和生產廠家名稱。
6. 對於滅菌後可重複使用的產品，應說明適當的重複使用方式，包括清潔、消毒、包裝、再滅菌和重複使用最大次數。
7. 運用輻射為治療目的之產品，需註明輻射的特性、類型、強度和擴散內容。
8. 說明書的包裝日期。
9. 其他技術內容，例如醫療器材的特性。
A party seeking a certification to import medical devices shall submit to the Director of the Medical Device Information and Technology Assistance Center (MDITAC) Attached Application for Product Manufacturing (Import) Certification(including an electronic application form), Application for Manufacturing (Import) Notification Report(including an electronic application form).
Application for Product Manufacturing (Import) Certification
．Applicant(Representative): 1.Name 2. Date of Birth 3. Address.
．Importer:1. Company Name (Business Name) 2. Business License No 3. Address.
．Product: 1.Name (Product Name, Item Name and Model Name) 2. Classification No. (Class) 3. Appearance and Structure 4. Raw Materials 5. Manufacturing Method 6. Performance 7. Purpose of Use 8. Method of Use 9. Precautions of Use 10. Packing Unit 11. Storage Method and Shelf-Life 12. Test Specifications 13. Manufacturing Site (In Case of Consignment of All Import or Manufacturing Processes) etc.
．Application process: Fill out Application→Submit→Review→Approval→Prepare Certificate→Issue Certificate
Application for Manufacturing (Import) Notification Report
．Applicant(Representative): 1.Name 2. Date of Birth 3. Address.
．Importer:1. Company Name (Business Name) 2. Business License No 3. Address.
．Product: 1.Name (Product Name, Item Name and Model Name) 2. Classification No. (Class) 3. Appearance and Structure 4.Performance 5.Purpose of Use 6.Method of Use 7.Precautions of Use 8.Manufacturing Site (In Case of Consignment of All Import or Manufacturing Processes) 9.Remarks
．Application process: Fill out List of Notification→Submit→Register to e-Government System of the Ministry of Food and Drug Safety.
Packaging and Labeling
．Method of Labeling: Labeling on a container, package, outer container, outer package, or package insert shall be performed in the manner provided in the following Subparagraphs.
1. All labels shall be in Korean or in Korean next to Chinese letters or foreign languages in the same font size.
2. Font size, spacing, and other labeling details shall follow the requirements specified and publicly announced by the Minister of Food and Drug Safety.
3. Braille may be used as label as per Paragraph (1) when printing a product name, manufacturer, or importer, etc. on a container, package, or outer package of a medical device.
．Labeling of Containers:Where a container or a package is too small or unable to hold all the information required in the Subparagraphs of Article 20 and the label is printed on the outer container or outer package or package insert; however, even in such cases, the model name and the name of manufacturer or importer shall be written on the container or package of the device
．Information in Package Insert:
1. Matters in Article 20 Subparagraphs 1 through 3 and 5 through 7 of the Act.
2. Intended use of the product
3. Storage method
4. For products manufactured entirely by a subcontracted domestic manufacturer, names and addresses of both the legal manufacturer (consignor) and the manufacturer (consignee)
5. For products packaged as a bundle of individual items, model name and manufacturer name shall be indicated on the smallest packaging unit
6. For products reusable after sterilization, indicate information on appropriate procedures for reuse including the methods of cleaning, disinfection, packaging, re-sterilization, and maximum number of reuse
7. For products emitting radiation for therapeutic purposes, indicate information on characteristics, type, strength, and diffusion of the radiation
8. date of the package insert prepared
9. Indicate other technical information, such as characteristics of the medical device
https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69735
HLF-TW-45
HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？
申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了韓文外，其他哪種語文也可以？網頁？
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Korean, which other languages are allowed? Website?
Evershine RD：
需要以韓國註冊營業的公司名義申請，及一位全職的品管經理。
進口醫療器材產品認證的申請人，應向醫療器材信息與技術支持中心提交產品製造/進口認證申請書及製造/進口通知申請宣告。
產品製造/進口認證申請
- 申請人(負責人) ：
- 姓名
- 生日
- 地址。
- 進口商：
- 公司名稱(商業名稱)
- 營業執照號
- 地址。
- 產品：
- 名稱（產品名稱、項目名稱和型號名稱）
- 分類號
- 外觀與結構
- 原料
- 製造方法
- 性能
- 使用目的
- 使用方法
- 使用注意事項
- 包裝單位
- 儲存方法和保存期限
- 測試規範
- 製造現場（所有進口或製造過程）等。
- 申請流程：填寫申請→提交→審查→批准→準備證書→頒發證書
製造/進口通知申請
- 申請人(負責人) ：
- 姓名
- 生日
- 地址。
- 進口商：
- 公司名稱(商業名稱)
- 營業執照號
- 地址。
- 產品：
- 名稱（產品名稱、項目名稱和型號名稱）
- 分類號
- 外觀與結構
- 性能
- 使用目的
- 使用方法
- 使用注意事項
- 製造現場（所有進口或製造過程）
- 備註。
- 申請流程：填寫宣告清單→提交→在食品藥品安全部電子政務系統註冊
醫療器材包裝內容及標示
標籤方法：於容器、包裝、外容器、外包裝或包裝說明書上，依下列各款規定進行標示
1. 所有標籤均應為韓文或韓國漢字。
2. 字體大小、間距和其他細節應遵循食品藥品安全部規定。
3. 在醫療器材的容器、包裝或外包裝上印刷產品名稱、製造商或進口商等時，必要時可以使用點字。
容器的標籤：即使容器或包裝太小以致於不能附有全部資料，且外容器/外包裝/說明書上已經印有標籤者，也應在設備的容器或包裝上載明型號名稱、製造商或進口商的名稱。
說明書的內容：
1.法令規定之臨床試驗內容。
2.產品的預期用途。
3.儲存方法。
4. 完全由國內製造商分包生產的產品，應註明法定製造商（發貨人）和製造商（收貨人）的名稱和地址。
5.成捆包裝的單件產品，在最小包裝單位上應標明型號名稱和生產廠家名稱。
6. 對於滅菌後可重複使用的產品，應說明適當的重複使用方式，包括清潔、消毒、包裝、再滅菌和重複使用最大次數。
7. 運用輻射為治療目的之產品，需註明輻射的特性、類型、強度和擴散內容。
8. 說明書的包裝日期。
9. 其他技術內容，例如醫療器材的特性。
To become a license holder, a company needs a registered place of business in Korea.
It is also required to have a quality manager as a full time employee.
A party seeking a certification to import medical devices shall submit to the Director of the Medical Device Information and Technology Assistance Center (MDITAC) Attached Application for Product Manufacturing (Import) Certification(including an electronic application form), Application for Manufacturing (Import) Notification Report(including an electronic application form).
A party seeking a certification to import medical devices shall submit to the Director of the Medical Device Information and Technology Assistance Center (MDITAC) Attached Application for Product Manufacturing (Import) Certification(including an electronic application form), Application for Manufacturing (Import) Notification Report(including an electronic application form).
Application for Product Manufacturing (Import) Certification
．Applicant(Representative): 1.Name 2. Date of Birth 3. Address.
．Importer:1. Company Name (Business Name) 2. Business License No 3. Address.
．Product: 1.Name (Product Name, Item Name and Model Name) 2. Classification No. (Class) 3. Appearance and Structure 4. Raw Materials 5. Manufacturing Method 6. Performance 7. Purpose of Use 8. Method of Use 9. Precautions of Use 10. Packing Unit 11. Storage Method and Shelf-Life 12. Test Specifications 13. Manufacturing Site (In Case of Consignment of All Import or Manufacturing Processes) etc.
．Application process: Fill out Application→Submit→Review→Approval→Prepare Certificate→Issue Certificate
Application for Manufacturing (Import) Notification Report
．Applicant(Representative): 1.Name 2. Date of Birth 3. Address.
．Importer:1. Company Name (Business Name) 2. Business License No 3. Address.
．Product: 1.Name (Product Name, Item Name and Model Name) 2. Classification No. (Class) 3. Appearance and Structure 4.Performance 5.Purpose of Use 6.Method of Use 7.Precautions of Use 8.Manufacturing Site (In Case of Consignment of All Import or Manufacturing Processes) 9.Remarks
．Application process: Fill out List of Notification→Submit→Register to e-Government System of the Ministry of Food and Drug Safety.
Packaging and Labeling
．Method of Labeling: Labeling on a container, package, outer container, outer package, or package insert shall be performed in the manner provided in the following Subparagraphs.
1. All labels shall be in Korean or in Korean next to Chinese letters or foreign languages in the same font size.
2. Font size, spacing, and other labeling details shall follow the requirements specified and publicly announced by the Minister of Food and Drug Safety.
3. Braille may be used as label as per Paragraph (1) when printing a product name, manufacturer, or importer, etc. on a container, package, or outer package of a medical device.
．Labeling of Containers:Where a container or a package is too small or unable to hold all the information required in the Subparagraphs of Article 20 and the label is printed on the outer container or outer package or package insert; however, even in such cases, the model name and the name of manufacturer or importer shall be written on the container or package of the device
．Information in Package Insert:
1. Matters in Article 20 Subparagraphs 1 through 3 and 5 through 7 of the Act.
2. Intended use of the product
3. Storage method
4. For products manufactured entirely by a subcontracted domestic manufacturer, names and addresses of both the legal manufacturer (consignor) and the manufacturer (consignee)
5. For products packaged as a bundle of individual items, model name and manufacturer name shall be indicated on the smallest packaging unit
6. For products reusable after sterilization, indicate information on appropriate procedures for reuse including the methods of cleaning, disinfection, packaging, re-sterilization, and maximum number of reuse
7. For products emitting radiation for therapeutic purposes, indicate information on characteristics, type, strength, and diffusion of the radiation
8. date of the package insert prepared
9. Indicate other technical information, such as characteristics of the medical device
https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69735
HLF-TW-55
HLF-TW-60
經過核准登記的醫療器材，進口到韓國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved health food into Korea? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
醫療器材銷售者或者出租人要求規定進行檢測，應當滿足下列要求：
1. 通過優良生產規範標準檢查、貼上檢查證書標籤的醫療器材產品。
2.遵循食品藥品安全部提供並公開宣布的相關程序、簽發檢驗證書、回覆期限、銷售或租賃規定等事項。
欲從事醫療器材銷售或出租業務者，應向政府提交醫療器材銷售/租賃業務報告（含電子申請表）：
- 報告者(負責人)：
- 姓名
- 居民登記號
- 註冊地址
- 營業地點：
- 營業地點名稱
- 通知編號
- 地址
- 申請流程：填寫申請→提交→審查→批准→準備通知證書→頒發通知證書。
豁免銷售業務報告：下列規定的醫療器材，可以豁免銷售業務申報：
1.避孕套。
2.嵌入或與手機/家電結合的血糖儀。
3.食品藥品安全部考慮到危險性和安全性已公開宣布的其他醫療器材。
Accomplish the following requirements if requested by a seller or lessor of a medical device to conduct testing pursuant to the article:
1. Inspect medical devices and release with inspection certificate labels attached only to those that are acceptable based on the good manufacturing practice standard.
2. Comply with the matters provided and publicly announced by the Minister of Food and Drug Safety in relation to procedures, method of issuing inspection certificates, response period, instructions for sale or lease, etc.
A party seeking to engage in the business of selling or leasing of medical devices shall submit a report of medical device selling (lease) business (including an electronic application form) to the Governor of the concerned Special Self-Governing-Province or the head of the Si, Gun, or autonomous Gu (The same shall apply hereinafter):
．Reporter(Representative):1.Name 2.Resident Registration No. 3.Place of Registration.
． Business Site:1.Name of Business Site 2.Notification No. 3.Address.
．Application process: Fill out Application→Submit→Review→Approval→Prepare Notification Certificate→Issue Notification Certificate.
Exemption of Report of Selling Business: The medical devices provided in the following Subparagraphs may be exempt from report of selling business:
1. Condoms
2. Glucometers that are embedded in or combined with mobile phones or electric home appliances
3. Other medical devices publicly announced by the Minister of Food and Drug Safety in consideration of level of hazard and safety.
【參考連結】
https://www.gov.kr/portal/main
HLF-TW-70
韓國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
．技術文件審查：根據法令規範，食品藥品安全部長官要求獲得製造許可或認證方可以提前接受技術文件的審查。
由食品藥品安全部指定的審查機構對醫療器材進行審查，申請技術文件等審查，應使用申請表，連同以下各項文件（包括電子文件）向食品藥品安全部或技術文件審查機構提交書面審查申請。
在結構、作用原理或性能、預期用途和方法與已獲得許可的醫療器材基本相同的醫療器材，不需要提交臨床研究數據，也不需要由食品藥品安全部公開宣布.第 5 至第 7 項資料亦豁免。
1. 與現有許可設備的比較資料
2. 預期用途資料
3. 行動原則資料
4.測試規範的相關資料、應用此類測試規範的理由以及用於驗證性能和安全性的實際測量數據。
對於國內外沒有的檢測規範，申請人應提供自己的規範、適用該規範的理由和實際測量數據，以驗證設備的性能和安全性
A. 電氣或機械安全資料
B. 生物安全資料
C. 放射安全資料
D. 電磁安全資料
E. 業績資料
F. 理化性質資料
G. 穩定性資料
5. 起源或發現資料及發展背景
6. 臨床試驗資料
7. 國外使用情況等資料
審查體外診斷設備方，應向食品藥品安全部長和技術文件審查機構提交書面審查申請及下列各款文件（包括電子申請表）：
1.發展背景、測量機制或方法、國內外使用情況
2.原材料和製造方法的資料
3.使用目的信息
4.儲存方法、保存期限或資料
5.每個項目中指定的用於驗證產品性能的資料，如以下
A.性能分析測試資料
B.臨床性能測試資料
C.質量管理測試資料
D.標準材料、材料存放等資料
6.體外診斷設備操作人員的安全資料
7.與現有許可設備的比較數據
以下醫療器材需通過韓國優良生產規範 (KGMP) 認證：
1. 第III、IV類醫療器材。
2. 第I、II類醫療器材在結構、原理、性能、使用目的、使用方法等與已獲批准之醫療器材有差異的設備。
所需文件：
1.製造和品質管理證明文件。
2.申請書。
3.技術文件審查結果。(必要時檢附)
4.身分證明文件。(必要時檢附)
．Review of Technical Documents: As required under the Act, by the Minister of Food and Drug Safety, a party seeking to obtain a manufacturing approval or certification may receive, in advance, a review of the technical documents.
A party seeking a review of technical documents, etc. shall submit to the Minister of Food and Drug Safety or to the head of the technical document review body a written application for review using Attached Form No.8 (including an electronic application form), together with the documents provided in the Subparagraphs (including electronic documents) below.
Medical devices, which are essentially equivalent to those already licensed with respect to structure, principle of action or performance, intended use, and methods are not required to submit data on clinical investigation and need not be publicly announced by the Minister of Food and Drug Safety. Data required in Subparagraphs 5 through 7 are also exempted.
1. Information comparing with existing licensed device
2. Information on intended use
3. Information on principles of action
4. Information on test specifications, rationale for applying such test specifications, and actual measured data for verification of performance and safety. For tests specifications unavailable domestically or internationally, the applicant shall provide his or her own specifications, rationale for applying such specifications, and actual measured data for verification of the performance and safety of the device
A. Information on electrical or mechanical safety
B. Information on biological safety
C. Information on radiological safety
D. Information on electromagnetic safety
E. Information on performance
F. Information on physico-chemical property
G. Information on stability
5. Information on origin or discovery and background of development
6. Information on clinical trials
7. Information on usage, etc. in foreign countries.
A party seeking a review of technical documents, etc. of in-vitro diagnostic devices shall submit to the Minister of Food and Drug Safety and the head of the technical document review body a written application for review (including electronic application form), together with the documents provided in the following Subparagraphs (including electronic documents):
1. Information on the background of development, mechanism or method of measurement, and domestic or overseas use
2. Information on raw materials and manufacturing method
3. Information on purpose of use
4. Information on storage method, shelf life or expiration date
5. Information specified in each item for verification of product’s performance, as follows.
A. Information on analytical performance test
B. Information on clinical performance test
C. Information on quality management test; and
D. Information on standard materials, test specimen storage, etc.;
6. Information on safety of handlers of in-vitro diagnostic devices; and
7. Comparative data with an existing licensed device.
．Korea Good Manufacturing Practices (KGMP) certification: According to regulations, Class 3 and 4 medical devices and Class 1 and 2 medical devices that differ from approved medical devices in terms of structure, principle, performance, purpose of use, and method of use must pass GMP. Submit:
1. Manufacturing and quality management documentation.
2. Application.
3. Technical document review results. (attach if necessary)
4. Identification documents. (attach if necessary)
【參考連結】
https://emed.mfds.go.kr/#https://emed.mfds.go.kr
https://emed.mfds.go.kr/#!CEFAB01F010
HLF-TW-75
韓國醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
無特別規定，不過以下醫療器材需通過韓國優良生產規範 (KGMP) 認證：
1. 第III、IV類醫療器材。
2. 第I、II類醫療器材在結構、原理、性能、使用目的、使用方法等與已獲批准之醫療器材有差異的設備。
所需文件：
1.製造和品質管理證明文件。
2.申請書。
3.技術文件審查結果。(必要時檢附)
4.身分證明文件。(必要時檢附)
申請網頁：https://emed.mfds.go.kr/#https://emed.mfds.go.kr
According to regulations, Class 3 and 4 medical devices and Class 1 and 2 medical devices that differ from approved medical devices in terms of structure, principle, performance, purpose of use, and method of use must pass GMP. Submit:
1. Manufacturing and quality management documentation.
2. Application.
3. Technical document review results. (attach if necessary)
4. Identification documents. (attach if necessary)
URL：https://emed.mfds.go.kr/#https://emed.mfds.go.kr
HLF-TW-77
HLF-TW-80
外國子公司進口醫療器材後，如果委託韓國的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports health food and entrusts a distributor in Korea to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability?
Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
危險醫療器材等召回的標準和程序
．懷疑對人體有危害或可能危害人體的醫療器材，維修人員、銷售者或者出租人應立即停止維修、銷售或租賃該器材，並通知該醫療器材的製造商或進口商（召回責任方）。
．召回責任方，應核實召回的醫療器材是否製造、進口、銷售或出租，並符合以下各款：
1. 引起或可能引起不可逆轉的嚴重副作用或死亡。
2. 引起或可能引起可逆或暫時的醫療副作用。
3.不易產生副作用，但不符合標準規格，故有安全及療效顧慮。
．醫療器材經查證屬於各款規定的，召回責任方應立即採取停止銷售等措施，並於期限內回報食品藥品安全部地區負責人相關召回計劃。
Criteria and Procedures for Recall of Hazardous Medical Devices
．In the event that a medical device is suspected to have harmed or likely to harm human body, A repair man, seller, or lessor shall immediately discontinue repair, sale, or lease of such device and notify the manufacturer or importer of the medical device (hereafter referred to as “responsible party for recall”).
．The responsible party to recall the medical device, shall verify, whether the suspected medical device for recall is manufactured, imported, sold, or leased ,and the medical device falls under any of the following Subparagraphs:
1. Its use causes or is likely to cause irreversible, serious side effects or death.
2. Its use causes or is likely to cause reversible or temporary medical side effects
3. It is not likely to cause side effects but does not meet the standard specifications under act, thus, has safety and efficacy concerns.
．If a medical device is verified to fall under any of the Subparagraphs, the responsible party for recall shall take actions, such as immediate discontinuation of the sale of such device and submit to the head of the regional branch of the Ministry Food and Drug Safety concerned a recall plan within the periods provided in the Subparagraphs below from the date of verification.
HLF-TW-85
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