California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health – Food and Drug Branch) Updated February 19, 2021: Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility. If you navigate to, and open up the HMDR Exemptee Application (PDF), […]
Tag: licensing
FDA Recommends New Testing Standards for Home Use Devices | RAPS
“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be […]
Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce
“HDMA’s 2014-15 Factbook updates member financial, operational performance. The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was […]
It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!
The holidays are coming! Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December. Just get it done now, before: the kids get out of school you find yourself cooking in the kitchen shopping for the holidays Go to DREprof.com: The Designated Representative and Exemptee Training Website CA […]
FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com
“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines. The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment […]
Wishful Thinking?! Both Work Experience AND Training Are Required
This topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa. In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing […]