Selling medical equipment and supplies is no simple task. There are laws and regulations in place to ensure that manufacturers and distributors aren’t cutting corners and are delivering the highest quality products to the end user. It is important as a consumer to make sure than you are purchasing your medical equipment from a company that has a Pharmaceutical License.
This is not only important because of the lawfulness of the transaction, but also because it ensures that your equipment is coming from a company that has quality standards in place which ensure ultimate safety and reliability of your medical equipment.
According to Article 11 Section 4160 of the California State Board of Pharmaceuticals, “A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board”. When a company receives approval by the board and pays the required fee, the board then issues a license to the applicant. There are separate licenses required for each place of business owned or operation by the wholesaler or third-party logistics provider. The license is required to be renewed annually and are not to be transferable.
Now, under Article 2 Section 2023, dangerous devices are defined as “any instrument, apparatus, machine, implant, in vitro reagent, or contrivance, including its components, parts, products, or byproducts of a device, and accessories that are used or intended for either of the following:
(a) Use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a human or any other animal.
(b) To affect the structure of any function of the body of a human or any other animal.”
This would include EKG machines, ultrasound systems, stress test equipment, and much more!
Under Article 11 Section 4166, there is a precise code of practice for the shipping of dangerous drugs or devices. “A Wholesaler that uses the services of a third-party logistics provider or carrier, including, but not limited to, the United States Postal Service or a common carrier, shall be liable for the security and integrity of any dangerous drugs or dangerous devices, shall be liable for the security of any dangerous drugs or dangerous devices through that provider or carrier until the drugs or devices are delivered to the transferee at its board licensed premises.”
There must also be verification that the third-party logistics provider or owner of the dangerous devices has imposed obligations on the carrier to ensure safety of the transportation of these dangerous devices.
These are only a few of the many regulations required for any distributor or manufacturer of medical equipment or supplies. As you can see, it is imperative that sellers of such equipment abide by these rules and regulations. Fortunately for Jaken Medical customers, we are an authorized distributor of medical equipment and supplies that obtains a California Pharmaceutical License and is also ISO 9001:2015 Certified. We have been authorized by the State of California's Board of Pharmaceutical's for 15 years now. This means that our operations are legal, safe, and ensure an essence of quality for the end user.