In the vast field of medical devices, Class I medical devices are known for their diverse types and structures. Among them, plastic injection molded parts play a pivotal role as an indispensable component. Manufacturers of plastic injection molded parts for Class I medical devices create these critical plastic products through exquisite medical plastic molding processes. Firstly, it's important to clarify that Class I medical devices refer to those whose safety and effectiveness can be ensured through routine management, as stipulated in the classification management principles outlined in Article 5 of the national "Medical Device Supervision and Administration Regulations". Due to the wide variety of Class I medical devices, the following are examples to illustrate their richness.

I. Diverse Classification of Class I Medical Devices

Class I medical devices encompass a wide range of products, from surgical knife handles and blades to various clamps, forceps, dental instruments, orthopedic surgical tools, and more. Specifically, they include but are not limited to:

• Surgical instrument series: such as surgical knife handles, blades, skin graft knives, providing surgeons with precise surgical tools.
• Surgical scissors and clamp series: including general surgical scissors, tissue scissors, hemostatic clamps, etc., meeting the needs for cutting and clamping different parts during surgery.
• Forceps and needle series: such as small vessel forceps, non-traumatic forceps, arterial needles, etc., serving as valuable assistants for delicate surgeries.
• Dental and orthopedic instrument series: including dental files, bone hammers, steel needle and screw positioning frames, etc., providing professional support for dental and orthopedic surgeries.

II. Differences Between Class I, Class II, and Class III Medical Devices

So, what are the differences between Class I medical devices and Class II, Class III medical devices?

1. Different Meanings:
   • Class III medical devices: the highest level, requiring strict control, implanted in the human body, supporting and maintaining life, with potential risks.
   • Class II medical devices: requiring control, including X-ray machines, ultrasound B scanners, etc.
   • Class I medical devices: their safety and effectiveness can be ensured through routine management.
2. Different Levels of Risk:
   • Class III medical devices: pose higher risks and require special measures for strict control.
   • Class II medical devices: pose moderate risks and require strict control.
   • Class I medical devices: pose low risks and are subject to routine management.
3. Different Operating Regulations:
   • Class III medical devices: strict requirements for operating premises, warehouse area, and quality management personnel.
   • Class II medical devices: require registration with the local municipal food and drug administrative department and submission of relevant supporting documents.
   • Class I medical devices: registration is granted immediately if the documents meet the requirements; changes in registration information must be promptly updated.

Dongguan Yize Mold Co., Ltd., a standout in the industry, was established in 2007 and is headquartered in Dongguan, the manufacturing capital, with convenient transportation and logistics. As a company engaged in precision mold design and manufacturing, as well as precision injection molding production for many years, Yize Mold specializes in a complete set of solutions for the design, precision mold manufacturing, injection molding and assembly, and after-sales service of automotive connectors, medical product injection molding, cleanroom injection molding, PFA custom injection molding, and other products.

With exquisite craftsmanship, excellent service, and rich experience, Yize Mold has won the trust and praise of a wide range of customers. If you have any needs or questions regarding plastic injection molded parts for Class I medical devices, please feel free to contact us at: +86 13302615729 (WeChat, WhatsApp same number). Yize Mold is committed to serving you and creating a better future together!