This message was posted by a user wishing to remain anonymous
Willard,
Just curious, there is licensing in PA. Is there a fee there? From PA licensing site:
Any manufacturer, distributor and/or retailer of medical devices within the Commonwealth physically handling actual product must register unless acting with scope of practice license (i.e. Physician providing medical devices directly to his/her patients, pharmacies dispensing devices to their patients, hopsitals providing medical devices directly to their patients, etc). Please note, a medical device is an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat or prevent disease in man or animals. Some common examples of medical devices and facilities that may require registration: Dental laboratories, optical laboratories, durable medical equipment (DME) faciitlies, eye glasses/contacts retailers, prosthetics and orthotics sellers (specialized footwear/repairs/braces), etc. Note: Some devices contain prescription drugs or controlled substances. If a device contains prescription drugs then the business should register as a manufacturer, distributor or retailer of prescription drugs or controlled substances IF classified as such by the Federal Food and Drug Administration (FDA).
Here's an excerpt from an article written on state licensing:
All 51 jurisdictions within the US (50 states plus the District of Columbia) have some type of wholesale distribution licensing requirements, each with significant and unique challenges. In order for a company to both distribute and sell into a state, it must be aware of and compliant with all state licensure requirements.
For TX for example:
Manufacturer" means a person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device. "Finished Device" means a device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.
Fee Schedule For Device Manufacturers
License fees are based on gross annual sales of ALL devices sales at each licensed place of business.
Fees for Device Manufacturers - Initial/Renewal License or Change of Ownership
| Gross Annual Device Sales |
Licensing Fees |
| $0 – $499,999.99 |
$495 for each place of business |
| $500,000 – $9,999,999.99 |
$2,225 for each place of business |
| $10,000,000 or more |
$3,708 for each place of business |
Do companies not residing in these states actually pay these fees to every state is an interesting question.
Original Message:
Sent: 22-Jun-2018 14:52
From: Willard Sickles
Subject: District of Columbia Depart of Health "Licensing of Medical Devices"
I recently received a letter from the District of Columbia Depart of Health regarding "Licensing of Medical Devices" claiming manufacturers, distributors, etc. must pay $500 per year to be licensed to distribute medical dev ices in the District of Columbia. The regulation is 314 pages and contains many references to CFR and FDA. It appears the regulation is concerned mostly about radiation emitting devices and electrical devices but I am not sure what their definition of a medical device is.
Does anyone on RAPS pay this? I have never heard of any of the 50 states requiring a similar fee. I am familiar with the FDA Device Facility User Fee.
Willard Sickles, PE | Manager, Product Safety & Compliance Engineering
InterMetro Industries Corporation | 651 N Washington St | Wilkes-Barre, PA 18705
Bill.Sickles@Metro.com
www.Metro.com