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License fees for drug and
medical device manufacturers began as “registration fees” and have slowly
increased, but have never been adequate to fully pay for the actual costs of
license inspections. Until July 1,2005 the current fee for a Drug or Medical Device Manufacturing license is
$447.18. This fee does not take into account the complexity of the inspection, whether the inspection is new or a
renewal inspection and the actual time needed to adequately complete the
licensing process. Pursuant to the “Report to the Legislature Drug Manufacturing, Medical Device Manufacturing,
and Home Medical Device Retailer Licensing Costs and Fee Analysis Annual
Report” January 2003, the licensing fees for the Drug and Medical Device
licensing have been adjusted and become effective July 1, 2005 as follows:
Drug Manufacturing License
| New Drug Manufacturing License Fee |
$1,600 |
| Renewal Drug Manufacturing License Fee |
$1,300 |
| Special or Small Firms*:
-New and Renewal Drug Manufacturing Annual License Fee |
$850 |
| [Prescription Drug Marketing Act (PDMA) Evaluation Fee**] |
$100 |
*Special or Small Firms: This category is limited to firms that 1)only repack medical gas, or 2) employ three or fewer people and have an
annual sales of less that $500,000.
**
PDMA: Prescription drug manufacturers must add an additional $100.00 to the appropriate fee listed
above. Information relevant to PDMA, e.g., certification-of-personnel and
applicant fingerprint requirements, will be provided with all renewal
applications and can be reviewed at:
http://www.dhs.ca.gov/fdb/HTML/Drug/indexdru.htm.
Medical Device Manufacturing License
| New Medical Device Manufacturing License Fee |
$1,600 |
| Renewal Medical Device Manufacturing Annual License Fee |
$1,300 |
| Special Firms*
-New and Renewal Medical Device Manufacturing Annual License Fee |
$850 |
*Special Firms, this category is limited to firms that produce medical devices that are
classified by the federal regulations as “Class One” and have been exempted
from GMP requirements, and firms that only manufacture optical lenses (spectacle
lenses).
Report
to the Legislature Drug Manufacturing, Medical Device Manufacturing, and Home
Medical Device Retailer Licensing Costs and Fee Analysis Annual Report, January
2003 (pdf)
All questions regarding our license process may be directed to the
Medical Device Desk at (916)
650-6500 or fax (916) 650-6650. Product complaints may be made through our toll free line at (800)
495-3232.
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