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North American FDA Certification

  • Time:2021-07-27
  • Viewing count:1120
FDA certification process:

Step 1: Application acceptance

1, after receiving the requirements of the application, the certification body to the applicant to send a notice of acceptance, notify the applicant to send or send the relevant documents and information.

2, at the same time, the certification body to send related charges and notices.

3, the applicant will be required to provide information to the certification body.

4. After the payment, the applicant shall fill in the payment voucher as required.

Step 2: Data review

1, in the data review stage, product certification engineer needs to apply for unit division.

2, after unit division, if the need for sample testing, product certification engineer to the applicant to send a notice of sample and the corresponding notice of payment, at the same time, notify the applicant to send a notice of sample receipt to the corresponding testing institutions.

Step 3: Sample receiving

1. The sample shall be delivered directly to the designated testing institution by the applicant.

2. After the payment, the applicant shall fill in the payment voucher as required.

3. The testing institution shall check and accept the samples received and fill in the sample acceptance report. For unqualified samples, a notice of sample rectification will be issued and the sample acceptance report will be filled out after rectification.

4. After the sample acceptance, the testing institution shall fill in the sample testing progress form and report it to the certification institution.

5. After receiving the sample testing progress, the certification body will send a formal acceptance notice to the applicant after confirming that the relevant fees have been paid off, and send a test task book to the testing institution, and the sample testing will officially begin.

Step 4: Sample testing

1, the enterprise should do in the type test stage: send test samples, required parts and technical data, understand the test progress, if there is a nonconforming items to the sample test rectification notice for timely rectification.

2. After the sample test is completed, the testing agency shall fill in the notification of sample test results.

3, testing institutions will also test reports and other data to the certification body.

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