The US FDA does not have a specific document called a “technical file,” but it requires various documentation depending on the type of product and the regulatory pathway.
For medical devices, the equivalent documentation may include:
The FDA also requires establishment registration and device listing for manufacturers and initial distributors of medical devices.
In summary, the US FDA Technical File is a vital document for manufacturers seeking to market their products in the US. It provides comprehensive evidence of compliance with applicable regulations and helps ensure the safety and performance of products placed on the US market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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