Does The DivaCup have to adhere to governmental regulations and standards?
A. We are a holder of Medical Device Licenses with both the FDA and Health Canada. Under the regulations, and because it is a personal hygiene product, it is suggested that menstrual cups should be replaced once a year. The silicone used in The DivaCup – which is 100% plastic-free, BPA-free, latex-free and odorless – is the same material and grade approved for healthcare applications. Diva International Inc. is ISO 13485 certified to meet the new medical device requirements of Health Canada as of January 1st, 2003. This certification ensures that The DivaCup is manufactured, packaged, and sold following specific procedures that assure the highest quality, safety and effectiveness of the product. ISO 13485 is a Quality Standard governed by the International Organization of Standardization in Geneva, Switzerland, and is recognized and practiced in over 160 countries around the world. ISO 13485 is the quality standard for medical devices. It has been designed to ensure that companies foll
The manufacturer’s of The DivaCup hold Medical Device Licenses with both the FDA and Health Canada. Under the regulations, and because it is a personal hygiene product, it is suggested that menstrual cups should be replaced once a year. The silicone used in The DivaCup – which is 100% plastic-free, BPA-free, latex-free and odorless – is the same material and grade approved for healthcare applications.
