Join us for this informative webinar designed for China-based pharmaceutical and API manufacturers preparing Master File (MF) submissions to global regulatory agencies, including the U.S. FDA, Health Canada, EMA, and others. This session will provide essential insights into the MF lifecycle and help ensure your submissions are secure, complete, and compliant.
Topics include:
- Types of Master Files and their regulatory purpose
- Required documents for submission across various agencies
- eCTD formatting standards and electronic submission pathways
- Agency-specific requirements, including when an authorized party is needed
- Global fee structures, including FDA GDUFA and Health Canada user fees
- How to keep Master Files active through updates and reporting
- Best practices for maintaining confidentiality and protecting sensitive data
- How Registrar Corp supports secure and compliant submissions as a U.S. Agent
Live Q&A:
Engage directly with regulatory experts and get answers to your specific submission challenges.
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.
