The FDA is responsible for regulating medical devices in the United States. This includes approving new devices, inspecting manufacturing facilities, and tracking post-market performance.
If you are a manufacturer of medical devices, you must register with the Food and Drug Administration (FDA). The purpose of registration is to ensure that FDA receives accurate information about your company so that it can keep track of what is being manufactured and sold in the marketplace.
The primary benefit of registering with the FDA is that manufacturers can make claims about their products that have been evaluated by the agency. This means that if your product makes a claim related to its use on or in humans, then it must be supported by scientific evidence or clinical studies.
When you want to sell medical devices, the FDA is your primary concern. This is true even if you’re a small entrepreneur, because medical devices are regulated. Your actions are heavily scrutinized from top to bottom by the FDA. This can make it hard for small businesses to embrace as they struggle to keep up with regulations. It’s easy for entrepreneurs to remain in compliance because the FDA does work hard at streamlining the process for them. After all, if it was too complicated for them, then everyone would get screwed over by violations and hefty fines. There’s a lot of information on the web that is just plain wrong on this subject matter.
What is Medical Device Registration under US FDA?
Any facility which manufactures or handles any part of the process of manufacturing and shipping Medical Devices in USA needs to register with USFDA.
If a product is to be determined as a medical device it has to meet the definition of medical device as defined in Section 201(h) of the Food, Drug, and Cosmetic Act. Some example of medical device are – Tongue Depressor, Pacemakers, Measuring devices, thermometers, X ray machines, in vitro diagnostic products like blood glucose meter, covid testing kit, reagents etc are also considered as medical device. These are typically hardware device.
As of December 2019, the USFDA considers software used with the hardware as part of the Medical Device.
Who needs Medical Device Registration?
Owners or operators of establishments or facilities that are involved in the production and distribution of medical devices need to register with USFDA. These devices may be intended for use in the USA or maybe exported from USA.
Both Foreign and Domestic establishments are required to register with FDA
This registration is an annual process. It must be renewed every year. Process fees must be paid on a yearly basis.
The definition of establishment and the spectrum of services covered under the ‘production’ are:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Initial Importer
- Manufacturer
- Re-packager
- Re-labeler
- Remanufacturer
- Re-processor
- Specification Developer
All the above are required to register with FDA under medical device regulations
How to Register For Medical Device?
Primarily the FDA requires the manufacture to register its establishment and appoint a US Agent for Foreign facilities it also requires to list the device along with the activities that are performed on the device. It the device mandates a premarket submission then
- Most Class 1 Device can be listed directly without any PMN or PMA
- Pre- Market Notification – 510K- Mostly Required for Class II Device
- Pre- Market Approval – Mostly Required for Class III Device
- HDE – Humanitarian Device Exemptions – For Rare dieses or conditions
After this registration, a payment needs to be made for the annual registration. The payment can be made via:
- Electronic Payments (such as credit cards or ACH electronic checks).
- Mailing in a Paper check drawn on a U.S. bank in U.S. currency
- Wire Transfers
Renewal of Medical Device Facility and Fees for the same is to be done Every year before 31st Dec
Who We Are and How We Can Help You?
FDApals is a regulatory services company with a track record for getting it done. We make sure you’re ready for compliance, no matter what the industry or sector you operate in. Our passionate team of consultants and dedicated professional services teams are on hand to help. We have over 30 years of experience, and we’ve helped over 1,000 clients across the globe. When you work with FDApals, you will be able to rest assured knowing that your company will meet all of the requirements set forth by the FDA.
We can help you comply with regulations and avoid penalties so that you can focus on your core business. We’re happy to provide you with a quote for our services. You can reach us at +91-989-051-2558
