Tuesday, July 7, 2009

CA HMDR FAQs

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Here's something you might find helpful, The CA Home Medical Device Retailer (HMDR) licensing program Frequently Asked Questions (FAQs)

Here are the questions that are answered:
  1. What is an HMDR business and who needs an HMDR license from the DHS, Food and Drug Branch?
  2. Where can I get an HMDR license application and what are the fees?
  3. Are there exceptions to the kinds of facilities that are required to have an HMDR license?
  4. What is the licensing process and how long does the process take?
  5. Can I operate my HMDR business without a valid license?
  6. After my facility is inspected, how long afterwards must I wait for my facility license?
  7. If my facility fails to meet compliance standards, what happens?
  8. If I move or sell my business, can my license be transferred?
  9. What is a Temporary License, and what are the criteria for receiving one?
  10. What are dangerous or “legend” devices?
  11. I wish to dispense legend medical devices from my HMDR. Do I need a special license?
  12. How can I obtain an HMDR exemptee license?
  13. Can I obtain an exemptee license without working at a HMDR facility?
  14. What about HMDR renewal inspections? How frequently are they conducted, and what are some common violations found?
  15. How can I get a copy of the HMDR Law and/or guidance on requirements?
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