The United States Pharmacopeia, a non-profit organization, recommends the raw materials used in the manufacturing of a medical device shall be of Class VI compliant. This means that the raw materials shall pass three important tests of a systematic injection test, an intracutaneous test and implantation test.
Also, as per the US FDA Guidance and Medical Devices Rules, 2017 all medical devices that have contact with human body shall be compliant to biocompatibility standards as per ISO 10993. For a menstrual cup, cytotoxicity, skin sensitization and vaginal irritation tests are mandatory.
