Oral care regulatory documentation
Start with the product and destination market.
For toothpaste, mouthwash, toothbrush or dental floss projects, the document review starts with the product and destination market. Airsun confirms available manufacturer information; additional testing or third-party services may be needed.
- Submit the requirements
- Provide the product, destination and requested documents, including requirements supplied by your customer or local adviser.
- Confirm the scope and responsibilities
- Review what is available, identify additional work and agree which party will provide each item.
- Prepare and provide the agreed documents
- Coordinate manufacturer information and any agreed supporting services for the project review.
Manufacturer documents for your oral care project.
Document availability and scope are confirmed for the specific product and destination. A certificate or document for one product does not establish suitability for every product or market.
- Certificates and licenses
- Relevant full documents and their applicable scopes can be provided following discussion of your review requirements.
- Testing and quality records
- Relevant test reports and redacted inspection or release records support project assessment.
- Product specifications and ingredient information
- Product specifications and ingredient information can be provided for the agreed purpose, with ingredient disclosure subject to confidentiality arrangements.
- Safety data sheets
- SDS can be provided where applicable to the product and documentation requirements.
Agree the responsibilities before preparation.
The customer or its appointed local organisation normally handles destination-market registration, notification and market-entry procedures. Airsun supports this work with the agreed manufacturer information.
The parties confirm the document list, responsibilities and any additional testing or third-party services before preparation. Support is assessed for each project and does not constitute a general guarantee of market approval.
Discuss the documents your market needs.
Discuss document availability and any additional work before preparation begins.
Request a documentation review