When it comes to developing medical devices, labeling is one of the most important procedures that go into the process. The device label indicates that the equipment is safe to use and designed in such a way that it protects the patients. If you are developing medical equipment, the first thing that you need to understand is whether the product you’re developing meets the definition of medical devices. And if it does, you should then verify the regulation that applies in your territory and then begin with the labeling process.
Let’s first understand what can be termed a medical device: The FDA implies that medical devices include all types of goods that are used to diagnose, cure, mitigate, or treat different health conditions. So, if the equipment you’re developing or have developed can be used for any of these purposes, you will need to get it labelled. So there is a wide range of products covered by the medical device regulation, ranging from simple surgical implements to advanced tools and procedures. So, if your equipment falls into one of these categories, the next step should be to determine whether your organisation will represent the link in the mandated label supply chain.
The FDA Rule for Labeling Medical Device: The rule for labeling medical devices is centred around the unique device identification system, where each device receives a UDI label. This label uses a common prefix on different devices as a product identifier, which helps the users track the product. So, the FDA Medical Device Packaging Regulations requires all the items to have the UDI label on the packaging. This UDI label includes a plain text version of the UDI code with a barcode. The FDA label includes information including brand name, description, size, catalogue number, expiration date, handling information, company name, physical address, and more.
If Your Company Manufactures Medical Device, Do This: If your industry is a medical device manufacturer, the goal is to make sure that your products gets labeled. And to achieve this, make sure that the processes are heavily automated, easily repeatable, and comply with the rules and regulations. You need to have a right labeling solution in place, doing so will help you ensure that you can avoid unnecessary relabeling and compliance, as you can get your entire supply chain of suppliers, distributors, and third-party logistics providers in line with your solution, this way, you can avoid any further complications. When you have the right labeling solution, you can deliver accurate medical labels for every medical device and item that you manufacture and produce. No matter the region you are from, if you are a medical device manufacturer, your first step should be to focus on developing the right labeling solution.
So, if you are a medical device manufacturer, make sure to go through the FDA Consent Decree List and make sure not to violate it to avoid any issues.
