The Ultimate Guide to Medical Device Packaging

Medical Device Packaging 101

When it comes to medical devices, packaging plays a crucial role in ensuring the safety and efficacy of the product. From cancer test kits to glucose monitoring devices, the packaging used for medical devices and kits must meet strict regulations and guidelines set by the FDA. In this guide, we will explore the different types of medical device packaging, the materials commonly used, and the regulations that must be followed.

Types of Medical Device Packaging

When it comes to medical device packaging, corrugated boxes are one of the most popular options. Corrugated boxes are made from layers of paper that are pressed together to create a strong, yet lightweight material. This construction provides the boxes with strength and durability, making them suitable for heavy and fragile medical devices. Corrugated boxes are also customizable, allowing manufacturers to print important information such as product name, batch number, and expiration date.

Other types of medical device packaging include:

  • Corrugated boxes for medical device kits: Glucose monitor testing kits typically come in corrugated boxes that are specifically designed to protect the delicate components of the kit.
  • Genetic testing kits: This type of packaging is used for DNA testing kits and must keep the samples secure and prevent contamination.
  • Healthcare packaging: This type of packaging is used for a wide range of medical products, such as bandages, gauze, and surgical instruments. It must be easy to open and close, and provide a barrier against bacteria and other contaminants.
  • Medical device kits: This is when medical devices are packaged together for ease of use. The packaged devices are intended to remain together and should not be substituted, repackaged, sterilized or modified before being utilized by the end user.
Medical Device Packaging

Materials Commonly Used in Medical Device Packaging

Medical device packaging is typically made from materials that provide a barrier against moisture, light, and bacteria. Some of the most common materials used include:

  • Plastic: Plastic is a popular choice for medical device packaging as it is lightweight, durable, and can be formed into a variety of shapes.
  • Paper: Paper is also commonly used in medical device packaging. It is biodegradable and can be recycled.
  • Tyvek: Tyvek is a synthetic material that is often used in medical device packaging. It is strong, tear-resistant, and provides a barrier against moisture and bacteria.
fda approved packaging

Regulations and Guidelines for Medical Device Packaging

The FDA has strict regulations and guidelines that must be followed when it comes to medical device packaging. Some of the key regulations include:

  • Pre-approval of packaging materials: Packaging materials must be pre-approved by the FDA before they can be used for medical devices.
  • Packaging must protect the contents: The packaging must protect the contents from damage, contamination, and degradation.
  • Packaging must provide adequate information: The packaging must provide adequate information about the contents and how to use them.
  • Packaging must be tamper-evident: The packaging must be tamper-evident, meaning that it must be visibly apparent if the packaging has been opened or tampered with.
  • There are also FDA labeling regulations requirements that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices.

At, we are an expert medical device packaging supplier and we understand the importance of providing packaging solutions that meet these regulations and guidelines. We have a wide range of corrugated boxes and other materials that are suitable for medical device packaging. Contact us today to learn more about how we can help you with your medical device packaging needs.

In conclusion, medical device packaging plays a crucial role in ensuring the safety and efficacy of the product. It’s important to choose the right type of packaging, materials, and comply with the regulations set by the FDA. If you’re in need of medical device packaging, is your best choice, visit our website and contact us today.

medical device packaging manufacturer by Influence Packaging

Influence Packaging is an award winning Custom Box Packaging Company leading the best packaging projects since 1994.
We are headquartered in Oakland (San Francisco Bay Area), California and we can’t wait to hear about your next packaging project!