For the export of sanitary products and their subsequent commercialization in the United States, we must register the product in the FDA.
The documentation that we must submit will depend on the level of risk of the medical devices, requiring a prior authorization to commercialize the products of class III, the presentation of a dossier 510k for products class II and some class I. Some low risk products can be exempt from presenting a dossier.
QUALIPHARMA MEDICAL DEVICES, together with its partner located in the USA, supports its clients in all the activities necessary for the commercialization of medical devices:
- Consulting and implementation of Quality Systems: 21 CFR Part 820.
- 21 CFR Audits Part 820.
- Support in the classification strategy: Class I, II & III Devices.
- Preparation of dossiers for FDA:
- PreMarket Approval (PMA): Structure and contents.
- Pre-marketing notification: 510k file.
- Investigational Device Exemption (IDE).
- Representation as Agent for contact with the FDA Office.