Healthcare Device Licensing Renewal

Healthcare Device Licensing Renewal

A. Applicant / Responsible Party

Address:

Phone:    Email:

B. Current License Details

Current License Number:

License Issued To:

Current License Expiration Date:

C. Device Information (List each device to be covered by renewal)

Device 1 — Device Name:

Model / Version:    Manufacturer:

Unique Device Identifier / Serial No.:

Quantity in Service at Planned Sites:

D. Technical Maintenance and Inspection

Last Preventive Maintenance Date:

Date of Last Safety Inspection:

E. Regulatory Attestations and Certifications

Entity Type (select all that apply): Manufacturer Distributor Healthcare facility Individual

By checking the boxes below and signing this renewal, the applicant affirms the following statements under penalty of law:

I certify that all devices listed are maintained, tested, and operated in accordance with applicable safety standards, manufacturer instructions, and any regulatory requirements governing medical devices.

I acknowledge the obligation to report device-related adverse events, malfunctions, or patient injuries to the appropriate regulatory authority within required reporting periods and to maintain records of such reports.

I will retain device maintenance logs, calibration certificates, and user training records for a minimum period required by regulation and make them available for inspection upon authorized request.

Except as described in Section F, there have been no substantive changes to device hardware, intended use, device labeling, or responsible personnel since the prior license was issued.

F. Changes Since Prior License (if applicable)

G. Insurance and Liability Information

Policy Number:    Policy Expiration Date:

H. Privacy and Authorization

I acknowledge that any patient information associated with device operation will be handled in accordance with applicable privacy and confidentiality obligations. I further authorize inspections and release of device operation records to authorized regulatory personnel for licensing and compliance verification.

Authorization Expiration Date (if different from license renewal):

I. Attachments Checklist

Copy of current license or certificate

Calibration and validation certificates for equipment

Maintenance logs and preventive maintenance records

Operator training records (if applicable)

J. Certification

I certify, under penalty of law, that the information provided on this Healthcare Device Licensing Renewal application and any attachments is true, complete, and correct to the best of my knowledge. I understand that knowingly submitting false information may result in administrative penalties, denial or revocation of license, and possible criminal liability.

I further certify that I am authorized to request renewal of the license on behalf of the named applicant and that I will comply with all applicable standards, reporting obligations, and inspection requests by authorized regulatory officials.

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