KFDA

CERTIFICATION of KFDA (MFDSK)

1. The specified products related to consumer health and hygiene, such as Pharmaceuticals, Quasi-Drugs, Medical Devices, Cosmetics, Sanitary
   Products, Foods, should be manufactured or sold only after Registration, Report, Permission or Approval by the Ministry of Food and Drug Safety of Korea (MFDSK ; KFDA).

1. DaeHan Public Administrative Attorney has been carrying out the entire Certification Process of KFDA in Product Analysis, Ingredient Analysis, Label Review, Grade Evaluation, Item Report (Permission), Manufacturing (Import) Report (Permission), Technical Construction File, Site Master File, Product Registration for the Certification of the Ministry of Food and Drug Safety of Korea (KFDA).

The Required Products for the Certification of KFDA

• The Products required to be certified by KFDA are Pharmaceuticals, Quasi- Drugs, Medical Devices, Cosmetics, Sanitary Products, Foods for the health and hygiene of consumers.
• The Report Items of KFDA are (1) Products not listed in the notices of KFD (2) Products not registered in KFDA (3) Products manufactured with those raw materials listed in KP (4) Products not specified by KFDA, and the Permission Items are the Products defined in the notices of KFDA.
• The General Items that do not fall to the Report and the Permission under the notices of KFDA are needed for Sales Registration or Business Report under KFDA.
• Overseas manufacturing plant should be registered in KFDA for medicines and the specified items, and those items are allowed to import to Korea without Certificate of Overseas Manufacturing Plant Registration.

1. DRUG : the Report or the Permission required

(1) Over-the Counter-Drugs (OTC Drugs)

• OTC drugs can be purchased at a drug store or a pharmacy without a doctor’s prescription because those are recognized little risk of side effects and misuse in terms of safety and effectiveness.
• OTC drugs contain lower active ingredient contents having lower effectiveness compared to Prescription Drugs.

(2) Prescription Drug

• Prescription Drugs can only be purchased with a doctor’s prescription because of high side effects and high risk and must be taken under the usage and dose according to the doctor’s diagnosis and instruction.

(3) Animal Drug

• Animal Drugs are intended for use only for animals. ● 214 kinds of Animal Drug are listed or licensed in KFDA, including
  antimicrobial, anthelmintics, pesticides, growth aids, anti-histamines, and
  nonsteroidal anti-inflammatory drugs, etc.

(4) Pharmaceutical Ingredients

• Those are used to make regular drugs raw materials or substances manufactured by synthesis, fermentation, extraction, or a combination of these methods, which are also known as Active Pharmaceutical Ingredients.

2. QUASI-DRUGS : the Report or the Permission required

Quasi-Drugs are defined in Article 2 of the Pharmacist Act, and are digestive drugs, pain relievers, ointments, and fatigue recovery drugs that can be purchased at general retail stores and in the Internet.

• (1) Textile or rubber products or similar products used for the purpose of treating, reducing, treating, or preventing human or animal diseases.
• (2) Products, which are not Instruments or Machines, having a weak effect on the human or does not act directly on the human.
• (3) Products for sterilization, insecticide, and similar applications to prevent infection.

3. MEDICAL DEVICES : the Registration, the Report or the Permission

Any devices, machines, materials, or similar products used alone or in combination with humans or animals, which are prescribed in Article 2 of the Medical Device Act,

• (1) Products used for the purpose of diagnosing, treating, mitigating, or preventing diseases.
• (2) Products used for the purpose of diagnosing, treating, mitigating, or correcting injuries or disorders.
• (3) Products used for the purpose of inspecting, replacing, or modifying structures or functions
• (4) Products used to control pregnancy

4. SANITARY PRODUCTS : the Registration or the Report required

Any products to improve hygiene and contribute to health improvement, and the typical products are as follows.

• (1) Oral products such as toothpaste and toothbrushes, etc.
• (2) Sanitizer such as shampoo, soap, etc
• (3) A razor and shaving forms, etc.
• (4) Cleaning agent
• (5) Sanitary towel, toilet paper, etc
• (6) Disposable kitchen utensils such as chopsticks and forks, etc.

5. COSMETICS

• Cosmetics are divided into General Cosmetics and Functional Cosmetics with specific functions such as whitening, wrinkle improvement, anti-aging,sunscreen, and hair improvement.
• General Cosmetics are required the Registration, and Functional Cosmetics are classified into the Registration, the Report or the Permission, depending on ingredients and efficacy.

6. FOODS

• Foods can be manufactured, imported, and sold only after the ingredient
  analysis and inspections stipulated in the Food Regulations.
• To prevent misunderstanding or misuse, labels must be attached, stating
  essential information such as ingredients, precautions, and expiration.

The Types of Certification of KFDA

The Certification of Ministry of Food and Drug Safety (KFDA) is classified into Registration, Report, Permission or Approval, based on test methods / standards and data that prove Safety⦁Effectiveness⦁Equivalence.

1. Registration

1. General products should be registered in KFDA, which do not fall under the Report Requirement or the Permission Requirement of KFDA. The typical registrations are Cosmetic Liability Sales for general cosmetics and Registration (Report) of Business for general foods, health functional foods, imported foods, food ingredients, sanitary products, etc.

Documents Required

• Documents from Manufacturer Manufacturing Permit, Sale Certificate, KGMP (cGMP), etc.
• Korea Office : Business License, Person in Charge, etc.
• Product Info : Consumer Manual, Label, Certificate of Analysis, etc.
• Overseas Manufacturing Registration : Site Master File, etc.

2. Report

It is required to prove (1) appropriate facilities and manpower, (2) Safety ⦁Effectiveness⦁Equivalence and (3) Criteria and Test Method in order to apply for Manufacturing (Import) Report (Permission) as well as Item Report (Permission).

Non-Noticed Products of KFDA

1. Products which are not listed in the Notices, registered in KP (Korea Pharmaceuticals (KP), or exempted from the regulation.

Functional Cosmetics

1. No. 1 : listed in the Notices of KFDA.
   No. 2 : the same functional cosmetics reviewed by KFDA.
   No. 3 : Similar functional cosmetics in No. 1 and No. 2.

식약처 인증절차

DaeHan Public Administrative Attorney has been carrying out the entire Certification Process of KFDA in Product Analysis, Ingredient Analysis, Label Review, Grade Evaluation, Item Report (Permission), Manufacturing (Import) Report (Permission), Technical Construction File, Site Master File, Product Registration for the Certification of the Ministry of Food and Drug Safety of Korea (KFDA).

Registration of Foreign Manufacturing Facilities

• Overseas Manufacturers must register the information as well as the summary data on manpower, facilities, manufacturing, and quality management since Dec. 12, 2020.
• The Registration Application for Overseas Manufacturing Plant shall be attached with a “Site Master File” with GMP details according to the PIC/S GMP guideline.
• Medicines and the specified items are not allowed to import to Korea without Certificate of Overseas Manufacturing Plant Registration.
• Overseas Manufacturers can obtain KGMP certification of KFDA through a simplified procedure if they have Certificate of an Overseas Manufacturing Plant Registration.

1. Required Documents

• (1) Information on Overseas Manufacturing Sites
  Longitude/Latitude, Manufacturing Permit, Business License, etc.
• (2) Certificate : ISO, GMP, etc.

2. Site Master File

• (1) General Information of Manufacturer
  Name, Location, Person in Charge, Contact information, etc.
• (2) Data on HR·Facility·Manufacturing·QC
  • 1) Plant Drawings
  • 2) Organization Chart for GMP
  • 3) Document Management
  • 4) Company Organization
  • 5) Production Management
  • 6) Quality Control
  • 7) Examination Management
  • 8) Shipment Management
  • 9) Consumer Complaints Handling
  • 10) Recall Management
  • 11) Other documents for GMP

Grade Evaluation of Medical Devices

The criteria of Grade Evaluation are Potential Risk Criteria

• 1. Degree of Invasion to Human Body : inserted or not
• 2. Period of Contact (Insertion) with the human body
• 3. The level of the drugs or energy delivery to the patient
• 4. The level of local or systemic biological effect on the patient

	Regulation	Item	Criteria
1st Grade	No Potential Risk	General Medical Device	Report
2nd Grade	Less Potential Risk	Electric bed, Recorders	Certificate/Permission
3rd Grade	Medium Level of Potential Risk	X-Ray, CT, MRI	Permission
4th Grade	High Level of Potential Risk	Others except 1st-3rd Grades	Permission

[Remark]
1. Comparative Similarity Test : if a similar product in the market
2. Clinical Experiment : No similar products in the market in Korea

Potential Risk Assessment Test

1. Similarity

1. The purpose of use, application, principle, characteristics, functions, etc. of the medical device is similar to the same items in the market.

2. Safety

1. The safety and performance are sufficiently secured compared to items classified and controlled.

3. Technicality

1. Data on comparison and analysis of technical characteristics such as structure, principle, performance, purpose of use, and method of use
   with other similar medical devices.

Custom Clearance for Imported Products

1. Registration Certificate of KFDA

1. General products should be registered in KFDA, which do not fall under the Report Requirement or the Permission Requirement of KFDA, and.
   Registration Certificate of KFDA should be enclosed for Custom Clearance Application, such as Cosmetic Liability Sales for general cosmetics and Registration (Report) of Business for general foods, health functional foods, imported foods, food ingredients, sanitary products, etc.

2. Import Report (Permission) and Item Report (Permission)

1. Import Report (Permission) and Item Report (Permission) is also required to be enclosed for Custom Clearance Application,

3. Report to the Korea Pharmaceutical Import and Export Association

1. The Importer should report their items to the Korea Pharmaceutical Import and Export Association.

4. Certificate of Registration of Manufacturing Facilities

1. Medicines and the specified items are not allowed to import to Korea without Certificate of Overseas Manufacturing Plant Registration.

Inquiry on the Certification of KFDA

Q & A

Our product is used as raw materials for pharmaceuticals as well as functional cosmetics. What kind of certificate of KFDA do we need ?

1. Cosmetics had been classified into the category of Pharmaceuticals, and it has been independently classified into the category of Cosmetics since 2002 after the Cosmetics Act enacted. and managed separately. Your product would be treated as raw materials for pharmaceuticals and need to get 3 Certificates of Import Report, Product Report and Overseas Manufacturing Plant Registration in order to export to Korea.

If we export a sprayer that sprays raw materials for functional cosmetics into the skin to Korea, should our sprayer be certified as a functional cosmetic or a medical device ?

1. Your sprayer would be regarded as a Medical Device. Thus, you need to get both certificates for (1) functional cosmetics certification as well as (2) medical device certification.

We want to export functional cosmetics to Korea. Do we need to establish a corporation in Korea ?

1. Foreign companies must apply for the certification of KFDA under the name of the Korean office for Consumer Protection and Recall. Thus,
   you need to set up a corporation or Branch in Korea. However, your Agents in Korea would apply for those certificates under their names if
   you appoint any Korean company as your agent, which fulfills those requirements, such as Facility Requirement and HR Requirement.

Consideration on the Certification of KFDA

1. Documents in Korean or English

1. All documents submitted to KFDA must be written in either Korean or English. Documents written in other languages must be submitted with
   notarization.

2. Apostille) or Korean Embassy Attestation

1. All essential documents such as manufacturing certificates, etc. must be attached with Apostille or Korean Embassy Attestation.

3. Appointment of Import Manager

1. A Pharmacist should be appointed as the Import Manager

Inquiry on Certification and Immigration

DaeHan Public Administrative Attorney’s Office has specializes in the Certification on CE & FDA, Foreign Invested Corporations (FIC) including Korea Branches and Liaison Offices, Immigration on Public Bond Investment and Real Estate Investment, and has provided Immigration & Investment Solutions, Consulting on D8, D7 Visa, Management, Tax and Marketing consulting. We can submit any application for licenses or permits on the behalf of clients.

Please contact us for the following issues. (1) Certification on CE & FDA (2) Establishment of Branches & Liaison Offices (3) Dispatch of Staffs on Long-Term Visas (4) Immigration on Public Bond Investment and Real Estate Investment (5) Visa Consulting on D8, D7, F5, F2 (6) Family Invitation & Immigration Issues (7) M&A & Technology Outsourcing (8) Stock Market Investment (KOSPI, KOSDAQ) (9) Management & Tax Consulting (11) Marketing & Trading Consulting.