태국 FDA는 제품군 별로 매우 까다로운 절차와 서류를 요청하고 있습니다.

NeuroAI는 전문 인력들의 풍부한 노하우로 저렴한 비용과 짧은 시간내에 승인 취득을 지원하며, 통관에 필요한 모든 서비스도 지원합니다.

" ​TFDA란? "

 태국 FDA는 공중 보건부 산하 기구로 태국 내에 수입, 판매 유통되는 아래의 강제 제품군들을 태국 국내 규제법 및 국제 협정에 따라 관리하는 기관입니다.

" FDA 이하 관리 제품군 "

  1. Drug

  2. Food

  3. Narcotic

  4. Cosmetics

  5. Hazardous Substance

  6. Medical Device

  7. Etc.

" NeuroAI 지원 서비스 "

  • 수입자 License 등록부터 TFDA 승인 취득까지 모든 서비스를 제공합니다.

  • ​제조사에서 해외 수출 시 필요한 공장 등록 및 수출 허가증 업무를 지원합니다.

 

" ​FDA:수입회사 라이센스 신청 절차  "

" 신청시 구비서류 "

  1. Application Form

  2. POA

  3. Passport or ID card (Copy)

  4. House particulars (Copy)

  5. Company License
    (Specify objectives regarding medical device trade)

  6. Photos of Businessman
    (1-1/2” , 3 picture)

  7. Medical certificate of businessman

  8. Map of company import / place storage (2 set)

  9. Diagram inside the place import medical device and storage location (2 set)

  10. Picture of company import / place storage (2 set)

  11. Medical device scope document
    (Common name & UMDN/GMDN Code)

  12. Label size of the place to import and place storage medical device

 

" 의료기기 수입 허가 절차"

" 구비 서류 "

  1. Application Form

  2. Company Import Register

  3. POA

  4. Passport or ID card (Copy)

  5. House particulars (Copy)

  6. Product Description
    6.1 Product name (Thai & English name)
    6.2 Scope of Medical Device
    6.3 Universal code of Medical device
    6.4 Name & address of factory
    6.5 Name & address of company import
    6.6 Executive summary
    6.7 Essential principles of safety and performance of medical device
    6.8 Device description
          -Device description & Features
          -Intended use , device labeling
          -Indications
          -Instructions for use
          -Storage condition, Shelf life
          -Contraindications, Warnings, Precautions
          -Potential adverse effects
          -Alternative therapy
          -Materials
          -Other relevant specifications
          -Other descriptive information
     6.9 Summary of design verification and validation
            documents
          -Results of examination or analysis from the
           laboratory such as Department of Medical Sciences
          -Biological compatibility study results
           (Depends on the product type)
          -Study results the shelf life of medical devices
           (if have shelf life)
    6.10 Device labelling
    6.11 Risk analysis
    6.12 Manufacturer information
    6.13 Certificate of free sale
    6.14 GMP or quality system certificate
    6.15 Declaration of conformity
    6.16 Letter of authorization for authorized representatives

Company Import Register

by E-Submission

Duration : Not more than 80 Days

" 구비 서류 "

  1. Company License, POA

  2. House registration of the importing place / cosmetic storage place with details of the host in case the applicant is not the host, attach the following documents.
    2.1 Letter of consent for use of the premises or lease
    2.2 Copy ID of the grantor / lessor
    2.3 Copy of house registration of the grantor / lessor
    2.4 Copy of the national ID card of the consentee / renter
    2.5 Copy of the house registration of the receiver / tenant

  3. Copy Passport or ID of Managing Director

  4. Copy Passport or ID of Manager

  5. Application Form ส.ค.1

  6. General information / quality manual, that has at least the following information.

  7. A brief map showing contact and nearby locations.

  8. A brief map showing import locations and nearby areas.

  9. Map at a glance showing cosmetic storage locations and nearby areas.

  10. Photos of the building, import sites / places to store cosmetics and the
          surrounding area of the building.

  11. Photo label (Not less than 15 x 45 cm) of "cosmetic import place" attached at the entrance to the place of importing cosmetics, which outsiders can clearly see and be in front of the place.

  12. Cosmetic information

  13. Front and inside photo / Import room

  14. Photos of ventilation systems or equipment such as vents / gates Air
          conditioning system fan.

 

" Notification Cosmetics Import Process "

" 구비 서류 "

  1. Application form จ.ค.1

  2. Company license , POA

  3. Copy Passport or ID of Managing Director

  4. Copy Passport or ID  of Manager

  5. Copy passport or ID

  6. Trade names in Thai and English.

  7. Thai and English cosmetic names

  8. Cosmetic use forms
    - Used then rinse
    - Do not wash off

  9. Cosmetic use forms
    - The area where the product is used
    - Purpose of using the product

  10. How to use

  11. Physical characteristics of cosmetics

  12. Physical characteristics of containers
    - AMPOULE/ VIAL
    - Other (specify)

  13. Conditions for cosmetic use specified in the Ministry of Public Health announcement (if any)
    - Do not use in children under 3 years.
    - Do not use in children under 10 years of age.
    - This product is not a spray product.
    - This product is not an aerosol spray product.
    -Must be mixed with other products before use.
       (The ratio of this product is 1: .... ratio)
    - Other.

  14. Cosmetic form
    - Single product
    - The same single product that has the same ingredients and uses but is  different in color or smell.
    - Many products included in the same package cannot be sold separately.
    - Single product that has been identified and combined into a single product package.

  15. Details of the operator (Import for sale)
    - Importer name, address, storage location
    - Manufacturer Name, address

  16. List of substances used as an ingredient in cosmetics Identified as International Nomenclature of Cosmetic Ingredients (INCI) Name
    16.1 Specify or attach the formula showing the name of every substance used as an ingredient.
    16.2 Show the amount and / or function of the substance specified in accordance with the notification of the Ministry of Public Health issued under Article 6 (3).
    16.3 Show the quantity and duty of the substance specified in accordance with the notification of the Ministry of Public Health issued under Article 6 (4).

     

*The cosmetic formula document must be issued by the manufacturer.

" Form จ.ค.1 "

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