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Do I need a license to sell medical devices in California?

Section 111656. 111656. (a) No person shall conduct a home medical device retail facility business in the State of California unless he or she has obtained a license from the department. A license shall be required for each home medical device retail facility owned or operated by a specific person.

How hard is it to sell medical devices?

Selling expensive medical devices is no easy task. Hospitals take procurement very seriously, which means you need to work diligently to capture the trust of potential buyers. But that can be difficult when it comes to items such as MRI machines or CT scanners, which represent large investments.

What is an HMDR license?

Home Medical Device Retailer (HMDR) Exemptee License In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home These devices/equipment are used to treat acute or chronic illnesses or injuries.

What is required to sell as a medical device?

As a DME retailer, you must register your business with the Food and Drug Administration (FDA). In addition, you will need to register your business in the states in which you intend to operate. Also, check if your state has a specific license requirement for durable medical equipment retail sales.

Who regulates medical devices in California?

Since 1970, CDPH has been mandated to license and inspect drug and medical device manufacturers, pursuant to HS Code Section 111635, to ensure products are safe and effective, and to verify that firms are operating in compliance with the HS Code and federal Good Manufacturing Practice (GMP) regulations.

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How long does it take to get a California medical license?

Since California is a high-volume applicant state, the California Medical Board requires that the board analysts have up to 90 business days in which to perform an initial review of your application and supporting documents. With that, the overall process typically takes three to five months.

Who regulates medical devices in California?

Since 1970, CDPH has been mandated to license and inspect drug and medical device manufacturers, pursuant to HS Code Section 111635, to ensure products are safe and effective, and to verify that firms are operating in compliance with the HS Code and federal Good Manufacturing Practice (GMP) regulations.

Do I need a license to sell medical supplies in USA?

In the vast majority of states, entities that sell medical gases or medical devices directly to consumers are required to obtain a license issued by the board of pharmacy or department of health. Some device distributors may even need to apply for more than one state-issued license.

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