What special regulations do color thermal labels used in the medical field need to follow?

Color thermal labels used in the medical field are subject to a number of special regulations to ensure their safety, effectiveness and compliance. Here are some of the main regulatory requirements:

First, medical device related regulations

1.Medical device specifications and label management regulations

Issued by: State Administration for Market Regulation

The main content: specifies the content, form, location and other requirements of medical device instructions and labels to ensure that product information is scientific, true, complete and accurate. For color thermal label paper, it is necessary to ensure that the product name, model specifications, manufacturer name, production date, use period and other information marked on it are clear and accurate, and comply with relevant regulations.

2.Medical Device Unique Identification (UDI) system

Implementation time: From June 1, 2024, for medical devices listed in the implementation product catalog, registrants need to carry out UDI related work in an orderly manner in accordance with the time limit requirements.

The unique identification of medical devices is the identification given to medical devices in their entire life cycle, and it is the "digital ID card" of medical devices. For medical devices using color thermal label paper, if they belong to the product range of UDI implementation, it is necessary to mark the UDI code on the label and ensure its traceability.

Second, regulations on the management of drugs and medical devices

1.Drug Administration Law and its implementing regulations

Although it is mainly for drugs, the provisions on drug packaging, labeling and instructions also have certain reference significance for medical devices. As a part of the packaging of medical devices, color thermal label paper needs to comply with the requirements of relevant regulations on packaging materials and label content.

2.Regulations on Supervision and Administration of Medical Devices

Issued by: State Council

Main content: The development, production, operation, use of medical devices and their supervision and management are comprehensively standardized. For the use of color thermal label paper, it is necessary to ensure that it complies with the provisions of the Regulation on medical device packaging, labels and instructions.

Third, other relevant regulations

1.Environmental protection law

With the increase of environmental awareness, the demand for environmentally friendly materials in the medical field is also increasing. As a disposable product, color thermal label paper needs to comply with relevant environmental regulations to ensure its recyclability or degradability and reduce pollution to the environment.

2.Quality management system certification

Medical device manufacturers need to pass quality management system certification such as ISO 13485 to ensure that product design, production, sales and other links meet international quality standards. For the production and use of color thermal label paper, it is also necessary to follow the relevant requirements of the quality management system.

Fourth, special requirements for specific application areas

For medical devices in certain application areas (such as implantable medical devices, sterile medical devices, etc.), more stringent labeling and packaging requirements may be required. For example, implantable medical devices need to be labeled with the words "implantable medical devices" and include other necessary safety warnings.

In summary, color thermal labels used in the medical field need to comply with a series of special regulations, including medical devices-related regulations, drug and medical device management regulations, environmental regulations, and special requirements for specific application fields. When producing and using color thermal label paper, enterprises should ensure that it meets the relevant regulatory requirements to ensure the safety and compliance of medical devices.