When a medical device manufacturer wants to market their products in the United States, they must register their establishment and list their devices with the Food and Drug Administration (FDA). Here are some key points to keep in mind regarding establishment registration and device listing with the FDA:
What is establishment registration?
Establishment registration is the process of registering a medical device manufacturing facility with the FDA. The registration process includes providing basic information about the facility, such as the name and address, as well as information about the types of Medical Device Consultants that are manufactured at the facility.
What is device listing?
Device listing is the process of listing all medical devices that are manufactured or distributed by a registered establishment with the FDA. The device listing includes information such as the device name, classification, intended use, and marketing status.
Why is establishment registration and device listing important?
registration and device listing are important because they allow the FDA to identify and track medical devices that are on the market. This helps ensure that the devices are safe and effective, and that they comply with all applicable regulations.
When is establishment registration and device listing required?
Establishment MHRA Registration and device listing are required for all medical device manufacturers who want to market their products in the United States. The registration and listing must be updated annually, or whenever there are changes to the manufacturing facility or the devices that are produced.
What are the consequences of failing to register or list devices?
Failing to register an establishment or list devices with the FDA can result in enforcement action, including fines, seizures, and injunctions. It can also result in delays in market entry and damage to a manufacturer's reputation.
In summary, establishment registration and device listing with the FDA are important requirements for medical device manufacturers who want to market their products in the United States. By understanding the requirements and consequences of failing to comply, manufacturers can ensure compliance with FDA regulations and successfully enter the market.