Medical Devices_FAQ-Zhongbang Registration Compliance

Is FDA registration different from CE certification?
A
The model of his certification is different from the CE certification of product testing + report certificate model, the FDA registration actually uses the integrity declaration model, that is, you are responsible for your own products meet the relevant standards and safety requirements, and register on the federal website in the United States, if the
Medical Devices FDA
Jul. 21th, 2023
Do I need to submit a supplementary application after the information in the package approval certificate has changed?
A
If the approved information of pharmaceutical packaging materials and pharmaceutical excipients has changed, the supplementary application shall not be reviewed and approved separately, and the supplementary application for approval shall not be issued. Pharmaceutical packaging materials, pharmaceutical excipients manufacturers should take the initiati
Medical Devices
May. 25th, 2021
What does NDC code mean?
A
An NDC code is an 11-digit identifier assigned by the FDA to identify a drug and its packaging. The NDC stands for National DrugCode, the "National DrugCode," which was introduced by the FDA in 1969. The NDC code consists of three parts, which are the drug manufacturer, the description of the drug and the package, and the package specification and quan
FDA FDA NDC
May. 15th, 2021
How long does it take for FDA NDC registration?
A
The time for FDA NDC registration varies depending on the completeness of the materials provided by the applicant and typically takes several months to a year for approval.
FDA FDA NDC
Jul. 25th, 2020
Can I entrust a professional agency to register FDA NDC?
A
Yes, the applicant can appoint a professional agency to handle the FDA NDC registration. This can reduce the applicant's burden and ensure the success of the application.
FDA FDA NDC
Jul. 25th, 2018
What is the NDC code?
A
The NDC code is a drug code issued by the FDA to identify the uniqueness of a drug in the United States market. The NDC code consists of three parts, including a 10-digit identification code, a 10-digit product code, and a 1-digit packaging code.
FDA FDA NDC
Jul. 25th, 2018

First Prev 1 2 Next Last

Hot News

Hot Tags

EU REACH
K REACH
EU CPNP
China cosmetics
FDA cosmetics
China Food contact