What is a medical product?
“Medical product” is a broad healthcare term that can refer to regulated products such as medicines, medical devices, biologics, and diagnostic products. It should not be confused with the narrower legal term medical device, whose exact definition depends on the applicable regulatory jurisdiction.
Answer
A medical product is a broad term used for products intended to support healthcare, diagnosis, prevention, treatment, monitoring, or disease management.
Depending on the context, medical products can include:
• pharmaceutical medicines
• medical devices
• in vitro diagnostic products
• biologics
• vaccines
• certain combination products
• healthcare supplies and consumables
However, “medical product” is not one single regulatory category with identical requirements for every item.
Different product types are regulated under different legal frameworks.
For example, a pharmaceutical medicine is regulated differently from a medical device. In the United States, FDA determines whether a product is a drug, device, biologic, or another regulated product based on statutory definitions and the product’s intended use and mode of action.
A medical device generally achieves its primary intended purpose through physical, mechanical, or other non-drug mechanisms rather than through chemical action or metabolism.
Examples of medical devices include:
• syringes and needles
• diagnostic test kits
• blood pressure monitors
• surgical instruments
• wound dressings
• catheters
• pulse oximeters
• imaging systems
• orthopedic devices
This distinction is important because manufacturing, registration, labeling, testing, and post-market requirements differ between pharmaceuticals, devices, biologics, and other medical products.
For medical-device examples, see AdvaCare Pharma’s medical device portfolio.
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