California Medical Device Licenses
Since 2008, the State of California has required medical device manufacturers physically located in California to be licensed with the state. That process involves filing an application, paying a filing fee and allowing state officials to inspect the facility prior to granting the license. These licenses are renewable every two years.
At the beginning of 2013, the licensing process changed somewhat. Now applicants, including renewal applicants, can avoid the state inspection under certain circumstances. Of note for members of The Vision Council, inspections will not be necessary if the applicant can provide the following:
- Proof of a valid FDA establishment registration and an attestation that a federal inspection was completed within the previous two years; or,
- Documentation proving compliance with audits conducted pursuant to ISO standards, such as ISO 9000 series, ISO 13485:2003, ISO 15378: 2006), or to a quality management system pursuant to 21 CFR §§ 210, 211 or 21 CFR §820.
- A licensing fee remains in place whether or not you are exempt from the inspection. New licenses will cost $1,600. Bi-annual relicensing is $2,600 for the two year period.
Questions can be directed to Rick VanArnam, The Vision Council's regulatory affairs counsel, at email@example.com (212) 725-0200 ex. 126.