韩国医疗器材登记法规问题集

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各国医疗器材登记法规问答集

HLF-TW-10
请问韩国对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：
韩国食品药品安全部将医疗器材进行定义和分类，单独或组合用于人或动物的任何仪器/机器/装置/材料或其他类似产品，但不包含药品、准药品，及残疾人辅具中的假肢/辅具，医疗器材分为以下类别:
1. 以诊断/治疗/缓解/治疗或预防疾病为目的之产品。
2. 以诊断/治疗/减轻/补充损伤或损害为目的之产品。
3. 用于测试/替换/修改生理功能之产品。
4. 用于避孕目的之产品。

韩国的医疗器材依据风险增加分为 I 、II 、III 、 IV 类，与GHTF/IMDRF 规则一致。
风险等级I 、 II 类由美国国家医疗设备安全信息研究所的医疗器材信息和技术援助中心认证，III、 IV 类由韩国食品药物安全部批准。
但以下类别的 I、 II 类设备必须获得韩国食品药物安全部批准：
1.需要临床测试报告。
2.与数位医疗相关的（例如远距医疗系统）。
3.尚未被定义及分类。
4.与药品结合。

上市前批准流程
．I类(通知)：须向韩国医疗器材信息与技术支持中心提出自我宣告。
．II 类(认证、批准)：需通过韩国医疗器材信息与技术支持中心认证，新器材需通过国家食品药品安全研究所（韩国食品药品安全部的附属机构）批准。
．III、IV 类(批准)：需通过国家食品药品安全研究所的批准。

网页：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

【参考连结】

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
外国公司要到韩国销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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。
医疗器材进口商应取得食品药品安全部核发的医疗器材製造及进口业务批准：

• 申请人(负责人)：
  1. 姓名(韩文、中文)
  2. 公司註册号或居民註册号
  3. 註册地址
• 进口商：
  1. 公司名称(商业名称)
  2. 地址
• 品管经理：
  1. 姓名
  2. 生日
  3. 资格类别

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

https://emed.mfds.go.kr/

HLF-TW-25

HLF-TW-30
外国公司要到韩国销售医疗器材，可以指派韩国公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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。在韩国没有办事处的外国进口商不得向食品药物安全部提交医疗器材申请，可以指定韩国许可证持有人来协调医疗器材在食品药品安全部的申请。
韩国许可证持有人需要在韩国有註册营业地的公司，及一位全职的品管经理，负责协助通过韩国海关清关产品、进口时的许可证和 KGMP 证书，在发生不良事件、召回时与食品药物安全部沟通，以及在召回的情况下与製造商通知、沟通。
欲取得进口医疗器材营业许可的申请人，应向食品药品安全部地区分局负责人提出申请:医疗器材製造/进口业务批准申请书(含电子申请书)、产品製造/进口认证申请、製造/进口通知申请报告。

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://emed.mfds.go.kr/

https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69735

HLF-TW-35

HLF-TW-40
外国公司销售到韩国医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文除了韩文外，其他哪种语文也可以？网页？

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。进口医疗器材产品认证的申请人，应向医疗器材信息与技术支持中心提交产品製造/进口认证申请书（含电子申请表）及製造/进口通知申请（含电子申请表）。

产品製造/进口认证申请

1. 申请人(负责人) ：
   1. 姓名
   1. 生日
   1. 地址。
2. 进口商：
   1. 公司名称(商业名称)
   1. 营业执照号
   1. 地址。
3. 产品：
   1. 名称（产品名称、项目名称和型号名称）
   1. 分类号 
   1. 外观与结构
   1. 原料
   1. 製造方法
   1. 性能
   1. 使用目的
   1. 使用方法
   1. 使用注意事项
   1. 包装单位
   1. 储存方法和保存期限
   1. 测试规范
   1. 製造现场（所有进口或製造过程）等。
4. 申请流程：填写申请→提交→审查→批准→准备证书→颁发证书

製造/进口通知申请

1. 申请人(负责人) ：
   1. 姓名
   1. 生日
   1. 地址。
2. 进口商：
   1. 公司名称(商业名称)
   1. 营业执照号
   1. 地址。
3. 产品：
   1. 名称（产品名称、项目名称和型号名称）
   1. 分类号 
   1. 外观与结构
   1. 性能
   1. 使用目的
   1. 使用方法
   1. 使用注意事项
   1. 製造现场（所有进口或製造过程）
   1. 备註。
4. 申请流程：填写宣告清单→提交→在食品药品安全部电子政务系统註册

医疗器材包装内容及标示

标籤方法：于容器、包装、外容器、外包装或包装说明书上，依下列各款规定进行标示。

    1. 所有标籤均应为韩文或韩国汉字。

    2. 字体大小、间距和其他细节应遵循食品药品安全部规定。

 3. 在医疗器材的容器、包装或外包装上印刷产品名称、製造商或进口商等时，必要时可以使用点字。

容器的标籤：即使容器或包装太小以致于不能附有全部资料，且外容器/外包装/说明书上已经印有标籤者，也应在设备的容器或包装上载明型号名称、製造商或进口商的名称。

说明书的内容：

1.法令规定之临床试验内容。

2.产品的预期用途。

3.储存方法。

4. 完全由国内製造商分包生产的产品，应註明法定製造商（发货人）和製造商（收货人）的名称和地址。

5.成捆包装的单件产品，在最小包装单位上应标明型号名称和生产厂家名称。

6. 对于灭菌后可重複使用的产品，应说明适当的重複使用方式，包括清洁、消毒、包装、再灭菌和重複使用最大次数。

7. 运用辐射为治疗目的之产品，需註明辐射的特性、类型、强度和扩散内容。

8. 说明书的包装日期。

9. 其他技术内容，例如医疗器材的特性。

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://emed.mfds.go.kr/

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/brd/m_40/view.do?seq=69735

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？
可允许的语文除了韩文外，其他哪种语文也可以？网页？

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：

需要以韩国註册营业的公司名义申请，及一位全职的品管经理。
进口医疗器材产品认证的申请人，应向医疗器材信息与技术支持中心提交产品製造/进口认证申请书及製造/进口通知申请宣告。

产品製造/进口认证申请

• 申请人(负责人) ：
  • 姓名
  • 生日
  • 地址。
• 进口商：
  • 公司名称(商业名称)
  • 营业执照号
  • 地址。
• 产品：
  • 名称（产品名称、项目名称和型号名称）
  • 分类号 
  • 外观与结构
  • 原料
  • 製造方法
  • 性能
  • 使用目的
  • 使用方法
  • 使用注意事项
  • 包装单位
  • 储存方法和保存期限
  • 测试规范
  • 製造现场（所有进口或製造过程）等。
• 申请流程：填写申请→提交→审查→批准→准备证书→颁发证书

製造/进口通知申请

• 申请人(负责人) ：
  • 姓名
  • 生日
  • 地址。
• 进口商：
  • 公司名称(商业名称)
  • 营业执照号
  • 地址。
• 产品：
  • 名称（产品名称、项目名称和型号名称）
  • 分类号 
  • 外观与结构
  • 性能
  • 使用目的
  • 使用方法
  • 使用注意事项
  • 製造现场（所有进口或製造过程）
  • 备註。
• 申请流程：填写宣告清单→提交→在食品药品安全部电子政务系统註册

医疗器材包装内容及标示
标籤方法：于容器、包装、外容器、外包装或包装说明书上，依下列各款规定进行标示

    1. 所有标籤均应为韩文或韩国汉字。

    2. 字体大小、间距和其他细节应遵循食品药品安全部规定。

 3. 在医疗器材的容器、包装或外包装上印刷产品名称、製造商或进口商等时，必要时可以使用点字。
容器的标籤：即使容器或包装太小以致于不能附有全部资料，且外容器/外包装/说明书上已经印有标籤者，也应在设备的容器或包装上载明型号名称、製造商或进口商的名称。

说明书的内容：

1.法令规定之临床试验内容。

2.产品的预期用途。

3.储存方法。

4. 完全由国内製造商分包生产的产品，应註明法定製造商（发货人）和製造商（收货人）的名称和地址。

5.成捆包装的单件产品，在最小包装单位上应标明型号名称和生产厂家名称。

6. 对于灭菌后可重複使用的产品，应说明适当的重複使用方式，包括清洁、消毒、包装、再灭菌和重複使用最大次数。

7. 运用辐射为治疗目的之产品，需註明辐射的特性、类型、强度和扩散内容。

8. 说明书的包装日期。

9. 其他技术内容，例如医疗器材的特性。

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://emed.mfds.go.kr/

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/brd/m_40/view.do?seq=69735

HLF-TW-55

HLF-TW-60
经过核准登记的医疗器材，进口到韩国要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：

医疗器材销售者或者出租人要求规定进行检测，应当满足下列要求：

1. 通过优良生产规范标准检查、贴上检查证书标籤的医疗器材产品。
2.遵循食品药品安全部提供并公开宣布的相关程序、签发检验证书、回复期限、销售或租赁规定等事项。
欲从事医疗器材销售或出租业务者，应向政府提交医疗器材销售/租赁业务报告（含电子申请表）：

1. 报告者(负责人)：
   1. 姓名
   1. 居民登记号
   1. 註册地址
2. 营业地点：
   1. 营业地点名称
   1. 通知编号
   1. 地址
3. 申请流程：填写申请→提交→审查→批准→准备通知证书→颁发通知证书。

豁免销售业务报告：下列规定的医疗器材，可以豁免销售业务申报：

1.避孕套。

2.嵌入或与手机/家电结合的血糖仪。

3.食品药品安全部考虑到危险性和安全性已公开宣布的其他医疗器材。

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.

【参考连结】

https://www.gov.kr/portal/main

https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69730&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3

HLF-TW-70
韩国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

．技术文件审查：根据法令规范，食品药品安全部长官要求获得製造许可或认证方可以提前接受技术文件的审查。
由食品药品安全部指定的审查机构对医疗器材进行审查，申请技术文件等审查，应使用申请表，连同以下各项文件（包括电子文件）向食品药品安全部或技术文件审查机构提交书面审查申请。

在结构、作用原理或性能、预期用途和方法与已获得许可的医疗器材基本相同的医疗器材，不需要提交临床研究数据，也不需要由食品药品安全部公开宣布.第 5 至第 7 项资料亦豁免。

1. 与现有许可设备的比较资料

2. 预期用途资料

3. 行动原则资料

4.测试规范的相关资料、应用此类测试规范的理由以及用于验证性能和安全性的实际测量数据。
对于国内外没有的检测规范，申请人应提供自己的规范、适用该规范的理由和实际测量数据，以验证设备的性能和安全性

A. 电气或机械安全资料

B. 生物安全资料

C. 放射安全资料

D. 电磁安全资料

E. 业绩资料

F. 理化性质资料

G. 稳定性资料

5. 起源或发现资料及发​​展背景

6. 临床试验资料

7. 国外使用情况等资料

审查体外诊断设备方，应向食品药品安全部长和技术文件审查机构提交书面审查申请及下列各款文件（包括电子申请表）：

1.发展背景、测量机制或方法、国内外使用情况

2.原材料和製造方法的资料

3.使用目的信息

4.储存方法、保存期限或资料

5.每个项目中指定的用于验证产品性能的资料，如以下

A.性能分析测试资料

B.临床性能测试资料

C.质量管理测试资料

D.标准材料、材料存放等资料

6.体外诊断设备操作人员的安全资料

7.与现有许可设备的比较数据

以下医疗器材需通过韩国优良生产规范 (KGMP) 认证：

1. 第III、IV类医疗器材。

2. 第I、II类医疗器材在结构、原理、性能、使用目的、使用方法等与已获批准之医疗器材有差异的设备。

所需文件：

1.製造和品质管理证明文件。

2.申请书。

3.技术文件审查结果。(必要时检附)

4.身分证明文件。(必要时检附)

．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)

【参考连结】

https://emed.mfds.go.kr/#https://emed.mfds.go.kr

https://www.mfds.go.kr/eng/brd/m_40/list.do?page=3&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=

https://emed.mfds.go.kr/#!CEFAB01F010

HLF-TW-75
韩国医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

Evershine RD：

无特别规定，不过以下医疗器材需通过韩国优良生产规范 (KGMP) 认证：

1. 第III、IV类医疗器材。

2. 第I、II类医疗器材在结构、原理、性能、使用目的、使用方法等与已获批准之医疗器材有差异的设备。

所需文件：

1.製造和品质管理证明文件。

2.申请书。

3.技术文件审查结果。(必要时检附)

4.身分证明文件。(必要时检附)

申请网页：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
外国子公司进口医疗器材后，如果委託韩国的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？

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：

危险医疗器材等召回的标准和程序

．怀疑对人体有危害或可能危害人体的医疗器材，维修人员、销售者或者出租人应立即停止维修、销售或租赁该器材，并通知该医疗器材的製造商或进口商（召回责任方）。

．召回责任方，应核实召回的医疗器材是否製造、进口、销售或出租，并符合以下各款：

1. 引起或可能引起不可逆转的严重副作用或死亡。

2. 引起或可能引起可逆或暂时的医疗副作用。

3.不易产生副作用，但不符合标准规格，故有安全及疗效顾虑。

．医疗器材经查证属于各款规定的，召回责任方应立即採取停止销售等措施，并于期限内回报食品药品安全部地区负责人相关召回计划。

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.

https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=69730&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3

HLF-TW-85

各国医疗器材登记法规问答集

**请注意下列事项：
以上内容为永辉研发及教育中心 (简称:永辉RD)于2021年10月摘要。
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