Medical Device Regulation

Role Of Medical Device Regulation

While it comes to medical device companies, you must know about medical device strategies and regulations, if you are serving the industry, since it is more compliance and regulation-driven industry. Whatever innovation and technology advancement you can bring to the medical device industry like it can be able to transform the industry operation or it is powerful enough to put the care delivery professionals years ahead of time. First, you must go through complex compliance and regulations procedures because the bottom line is the effectiveness and safety of the medical devices. You can have an overview of Medical Device Regulation while reading this information which is required at the time of the medical device design process.

Regulation For Medical Industry

The medical device is mainly regulated by the food and administration to ensure the effectiveness and safety of the device. While the center for devices and radiological health is the food and drug administration component and looks after this program. And these medical devices are classified into three categories based on the associated risk such as class I, II and II. In class I, devices will have the least associated risk while at class III devices will have the highest associated risk. According to the regulatory control surges from class I devices to class III devices. Most of the class I device is exempted from 510(k) pre-market notification submission, while other class II devices are submitted for its pre-market notification. Then this class III device needs to go through the pre-market Approval Application and other such class III devices are exempted from pre-market Approval Application must submit a 510(k) notification to food and drug administration.

Types Of Regulations For Medical Devices

First, let us look out the basic regulations that manufacturers and distributors must comply with and understand them one by one.

  • Establishment registration and medical device listing
  • Pre-market notification
  • Pre-market approval
  • Investing device exemption for clinical studies
  • Labeling requirement
  • Quality system regulation
  • Medical device reporting

Registration Process

First and foremost the medical device distributor and manufactures must register their organization with food and drug administration (FDA) to sell their device. Then all the establishment should be registered electronically using the FDA unified registration and listing system. This information is mandatory to verify registration every year.