OTC Medical Device Distributor Accreditation
To be eligible for OTC Medical Device Distributor Accreditation, businesses must first successfully complete our prerequisite Supply Chain Inspection. Review Supply Chain Inspection pricing to get started.
| Fees | Paid at Time of Supply Chain Inspection Application (To Determine Accreditation Eligibility) | Year 1 (Following Eligibility) | Year 2 | Year 3 |
|---|---|---|---|---|
| Supply Chain Inspection Inspection Fee | See Supply Chain Inspection pricing. | |||
| Eligibility Review Fee | $1,300 | |||
| Application Fee | $3,000 | |||
| Annual Participation Fee | $400 | $400 | $400 | |
| Estimated Total | Supply Chain Inspection + $1,300 | $3,400 | $400 | $400 |
Total 3-year Accreditation With Eligibility Review Fee: $5,500
Accreditation program fees are subject to change.
Additional fees may be assessed for the following occurrences:
- Time extension requests
- Protracted Policy and Procedure (P&P) reviews
- Delays related to survey scheduling
- Protracted survey remediation
- Ownership change processing
This list is not all-inclusive.
Bundle Accreditations to Maximize Your Investment
Save time and money by bundling our distributor accreditations together. When completing your OTC Medical Device Distributor Accreditation application, maximize your investment by also applying for our Drug Distributor Accreditation. Review eligibility requirements to see if your facility qualifies and contact our team for details and your facility’s discount code.
