Qua.Ser Ltd. performs following steps to obtain Certificate of Registration FDA for medical devices:
- Clients should register itself to FDA, at an annual cost of about $ 1.700
- after registration Clients should assess type of medical device that would register:
- Low-risk medical devices (such as gloves, tools) can be obtained through simplified procedure called “Device Listing.” After, FDA issues a registration number that allows export of medical devices.
- Medical devices already existing but more risky: Clients should issue a special procedure called 510(K). This procedure involves, in addition to pay fee for registration of company, a sum equal to $ 3.404.Companies should submit documentation for product (with any additions, if request) to FDA that assigns a letter of authorization to sell in U.S. and a registration number.
- – Innovative high-risk medical devices: Companies should follow full procedure defined “Premarket Approval, or PMA”.
3. Companies should have an official corresponding resident in USA, in accordance with Ch. 21 C.F.R. Section 807.25 (d) and section 807.40 of FDA Regulations.
Qua.Ser Ltd provides comprehensive support for recording every step