South Korea Medical Device Registration QA

Email: sel4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of China (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang

HLF-TW-10

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：

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】

HLF-TW-20

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：

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

【參考連結】

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

HLF-TW-25
假如需要辦理，請問韓國有專業服務公司可以協助辦理醫療器材公司營業許可證？

Evershine RD：

TÜV SÜD

EMERGO

https://www.emergobyul.com/

HLF-TW-30

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：

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.

【參考連結】

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

HLF-TW-35
假如需要辦理指派韓國公司擔任營業代理人，請問韓國有專業服務公司可以協助？

Evershine RD：

EMERGO

https://www.emergobyul.com/

Kobridge

https://kobridgeconsulting.com/

HLF-TW-40

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：

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

【參考連結】

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

HLF-TW-45
請問在韓國有哪些專業服務機構，可以協助辦理醫療器材產品許可證？

Evershine RD：

EMERGO

https://www.emergobyul.com/

TÜV SÜD

HLF-TW-50

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：

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

【參考連結】

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

HLF-TW-55

請問在韓國有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？

Biorius
https://biorius.com/

Evershine RD：

EMERGO

https://www.emergobyul.com/

TÜV SÜD

HLF-TW-60

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：

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

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

Evershine RD：

．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：

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

請問在韓國有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？

Evershine RD：

KTL https://www.ktl.re.kr/

KTR http://www.ktr.or.kr/

HLF-TW-80

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：

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.

【參考連結】

HLF-TW-85
請問在韓國有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？

Evershine RD：

Kim & Chang

https://www.kimchang.com/en/main.kc

JIPYONG LLC

https://www.jipyong.com/en/main/main.php

Contact Us

Seoul Evershine BPO Service Limited Corp.
3F., KS Building,60 Yeoksam Ro 17 Gil Gangnam-gu, Seoul (06237), South Korea
E-mail: sel4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of China (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang

Additional Information
Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

Please send email to HQ4sel@evershinecpa.com

More Cities and More Services please click  Sitemap