SQF Edition 10 has officially been released, introducing a new digital-first code format along with updated expectations around food safety culture, change management, and risk‑based environmental monitoring. These updates represent one of the most meaningful shifts in the SQF program in recent years, and facilities will need clarity and direction to prepare for future audits.
In this focused webinar, our experts will highlight the Edition 10 changes and what they mean for your programs, processes, and audit readiness. You will gain a clear understanding of new requirements, the value of these changes, how to navigate the digitized code more effectively, and understand where to prioritize internal updates.
What We’ll Cover
- How to navigate the new digital SQF Code and Code Selector tool
- Strengthened, measurable food safety culture expectations
- New mandatory change management requirements and what triggers them
- Risk-based environmental monitoring as a required program and how to approach it
- Key implications for training, documentation, and verification
Now is the time to start laying the groundwork for your first audit to Edition 10. You will leave the webinar with a set of actionable next steps. And we will leave ample time for Q&A with our panel experts.
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.
