Join Registrar Corp and the U.S. Commercial Service of the U.S. Embassy in Singapore for an exclusive webinar tailored for food and beverage exporters across ASEAN looking to enter and succeed in the U.S. market.
This webinar, “Unlocking the U.S. Food Market: FDA Regulations that Govern Exports to the USA,” will feature expert insights from Registrar Corp on navigating U.S. FDA regulations and identifying U.S. buyers. The U.S. Commercial Service will also present the SelectUSA program, highlighting resources and support available to foreign businesses looking to invest or set up operations in the United States. A live Q&A session will follow to address participant questions.
Whether you’re looking to expand into the U.S. market, ensure compliance with FDA regulations, or connect with U.S. buyers, this webinar will provide valuable guidance and resources to support your export success.
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.
