Australia and the European Union (EU) have now concluded negotiations for an Australia-EU Free Trade Agreement (A-EU FTA).
The EU is a sophisticated and competitive destination for cosmetics, beauty and personal care products. There is a strong demand for high-quality, differentiated products and clear expectations around:
- route-to-market strategy.
This webinar will explore how Australian cosmetics and beauty manufacturers can enter the European market and benefit from the Australia–EU FTA. It will also cover the key regulatory and commercial requirements for market access.
Participants will also learn about opportunities to engage with European buyers and distributors through Cosmoprof 2027 in Bologna, Italy.
This webinar is in collaboration with the Export Council of Australia and A-Beauty Export.
A-Beauty Export is an initiative to help Indigenous-owned beauty businesses build the knowledge, infrastructure and global connections required to enter international markets.
Key topics
- European beauty market overview
- Market positioning and commercial strategy
- Commercial opportunities and next steps
Who it’s for
- Australian cosmetics, beauty, skincare and personal care manufacturers
- New and experienced Australian exporters looking for opportunities in Europe
- Industry bodies, export advisers and state/territory partners supporting Australian beauty brands
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.
