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서비스 소개

미국 식품의약국(FDA)은 미국에서 의료 기기, 의약품, 생물학적 제품, 식품 등 다양한 제품의 안전성과 효과성을 보장하기 위해 규제를 담당하는 기관입니다.

FDA 등록은 해당 규제에 따라 제품을 시장에 출시하고 판매하기 위해 필요한 과정 중 하나입니다.

아래는 일반적인 절차, 필요서류, 소요기간, 비용 등에 대한 정보입니다.

서비스 구매를 완료하신 후, 필요서류를 “대시보드 – 메세지“를 통해 제출해주시기 바랍니다.


제품 카테고리: 화장품, 식품, 건강기능식품, 의약품, 의료기기 등

소요 기간: 영업일 기준 2~4주

유효기간: 1년 (이후 갱신 필요)



진행 절차

  1. 1. 사전 요건 확인:
    • FDA 규정 및 요구 사항에 대한 조사 및 문서 작성


  1. 2. 필요 양식 준비 및 제출:
    • 필요한 양식을 제출합니다.


  1. 3. 제출 및 검토:
    • 필요한 서류 및 정보를 제출하고, FDA에서는 이를 검토합니다.


  1. 4. 평가 및 피드백:
    • FDA에서는 제출된 정보를 평가하고 추가 정보나 수정이 필요할 경우 피드백을 제공합니다.


  1. 5. 서류 승인 및 등록:
    • 모든 요건이 충족되면 FDA는 서류를 승인하고 제품 등록을 완료합니다.



필요 서류

1.사업자등록증 영문

2. 제품 정보 링크

3. 제품 설명서 + 주의사항 (영문)

4. 제품 전성분표 (영문)




자주 묻는 질문

  • 유효기간 1년 만료 후 갱신이 필요합니다. 대시보드 – 메세지를 통해 문의주시기 바랍니다.
  • 사전조사: FDA 규정에 대한 충분한 조사가 필요합니다.
  • 정보 제출: 정확하고 완전한 정보를 제출해야 합니다.
  • 시간 계획: 등록 프로세스에는 충분한 시간이 소요되므로 미리 계획을 세우는 것이 중요합니다.




■ What if I have questions regarding the service ?

A: You can directly get consultation via our chat bot online.


■  What if I am not satisfied with the service?

A: you will have two revisions.


■ How can I get the tax invoice ?

A: Once you place the order, the tax will will be sent to you via email.


■ What if I have urgent modifications ?

A: You can contact us through the online chat or email so we can assist you best.


■ What if I can not find the service I need ?

A: Contact us via online chat / email or call, we can help you best.


■  Can I customize my service package ?

A: Yes, you can customize the service package based on your needs. Contact us


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FIKSBAY Cancellation and Refund Policies

Policy of cancellation

  1. Customers can cancel the service for free within 24 hours of purchasing it.
  2. If it exceeds 24 hours, a cancellation fee may be charged, set at a percentage of the purchase price. (A 80% fee is charged for the total amount of service)

Refund policy

  1. Refunds for canceled purchases will be processed within 5-7 business days from the date of cancellation.
  2. The refund will be made through the original payment method.
  3. Regarding the cancellation fee, the customer has to bear the fee applied at the time of the cancellation request.
  4. Purchased services can be fully refunded up to 24 hours in advance, after which they cannot be fully refunded. Instead, a partial refund policy may apply depending on the situation.
  5. If you request a refund due to reasons attributable to the customer during the service, it will proceed according to the Fiksbay refund policy.
  6. If the purchased service is in progress and canceled after 7 days, a full refund is not possible. 50 % refund is possible.
  7. Refunds arising from cancellations on the part of the service provider may be processed immediately and fully.

Special Terms

  1. If the service is not available due to unexpected circumstances or natural disasters, the customer will receive a full refund.
  2. For services related to a particular event or event, the cancellation and refund policies may vary, which will be announced on the event or event page.
  3. Changes to the service schedule purchased or cancellations due to special reasons may be considered individually. In this case, consultation with the customer service team is required. It is reviewed according to individual circumstances to decide whether to refund or not.

Cancellation of Service Provider

  1. If the service provider is unable to provide the purchased service, the customer will be notified as soon as possible.
  2. Refunds for service provider cancellations will be made at 100% of the canceled service amount.
  3. Alternative Service Delivery: Where possible, the service provider may suggest an alternative service or alternative schedule to the customer.

Reference points

  1. All cancellations and refund requests will only be processed through the Fiksbay.
  2. Refund processing may require information verification from the buyer (customer) for a smooth process.
  3. If there is a client’s verbal abuse, abusive language, or slander during free counseling or service, the free counseling and service will be terminated, and if you pay for it, it will not be refunded.
  4. Policies can be changed without prior notice, and if they do, the information will be updated immediately.

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