Medical Devices
Stay ahead with critical updates and insights on medical devices, their regulations, industry standards, and compliance strategies.
Medical Devices
Stay ahead with critical updates and insights on medical devices, their regulations, industry standards, and compliance strategies.
Featured Medical Devices Articles
Explore the crucial distinctions between a Class I medical device, Class II, and Class III while understanding their characteristics and regulatory nuances.
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Discover the essentials of FDA medical device regulations in this guide on Premarket Approval (PMA) with Registrar Corp's expert guidance.
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Latest Medical Devices Compliance Articles
As purchasing online becomes more common for businesses, the benefits of buying in your local currency are undeniable.
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Data Protection is a crucial element in choosing an FDA compliance partner. Discover its roll in long-term compliance for your business.
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Explore the crucial distinctions between a Class I medical device, Class II, and Class III while understanding their characteristics and regulatory nuances.
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Learn the difference between FDA clearance and FDA approval and how they apply to medical devices and drugs.
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Your concise guide to understanding and responding to a Notice of FDA Action. Explore types, strategies, and how to create effective Corrective Action Plans.
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Medical Devices Regulations FAQ
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.