What are the common problems encountered in FDA certification and CE certification?

Yesterday we learned what FDA certification is and what CE certification is. Today we will look at the common issues of these two certifications.

1. How much does EU CE certification cost?

Customers often ask how much the EU CE certification costs, why some certification fees are relatively low, while others are relatively expensive. Huabo Enterprise Testing Experts said that the EU CE certification costs mainly depend on the selected certification body and the relevant directives of the product. Different product testing items are also very different. Generally, common products are electronic and electrical products, and common test items are classified into EMC and LVD directives. The cost of CE certification for mechanical products is much higher than that of ordinary products, which involves factory inspection procedures and evaluations.

2. Does the FDA have a certificate? Which agency issued it?

There is no certificate for FDA registration. After the product is registered with the FDA, it will obtain a registration number. The FDA will give the applicant a reply letter (with the signature of the FDA Chief Executive), but there is no such thing as an FDA certificate.

3. How to choose the CE certification agency?

Most companies need TUV certification, but they think the quote is too expensive. TUV issues the CE certification, but in fact there are many certification bodies recognized by the EU, and you can choose any certification body recognized by the EU to pass the CE certification.

4. Does FDA registration require a U.S. agent?

Yes, Chinese applicants must appoint a U.S. citizen (company/association) as their agent when registering with the FDA. The agent is responsible for performing process services in the United States and is the medium for contact between the FDA and the applicant.

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