"The time has come to categorize medical films and highlight their role!"

On August 31, 2017, the National Medical Products Administration (NMPA) issued an important document to further regulate the medical device market, particularly focusing on the medical imaging and recording sectors. This revision primarily centered on the adjustments to the "Medical Device Classification Catalog," clearly defining the usage guidelines for medical image recording media and strengthening the management of different types of films.

According to the updated regulations, imaging recording media composed of polyester (PET) film base, anti-static layer, and ink-absorbing layer (such as silica, alumina, or other materials for ink or toner absorption) are primarily intended for printing non-diagnostic medical images and graphic/text records, such as ultrasound images. The main products involved include:

1. Medical print films: These films are used for printing medical images, typically for ultrasound images or other records, for reference or archiving purposes, rather than for diagnostic use.

2. PACS ultrasound diagnostic report films: These films are primarily used for printing ultrasound diagnostic reports within a Picture Archiving and Communication System (PACS), which is used for storing, viewing, and transmitting medical images, but not directly for diagnostic purposes.

3. Dry ultrasound diagnostic report films: Similar to PACS films, dry films do not require wet processing and are used for printing ultrasound reports in settings where wet development is not necessary.

However, the updated Medical Device Classification Catalog clearly stipulates that CT, MRI, CR, DR, and other imaging used for medical diagnosis cannot use these types of recording media. Since these images are critical for clinical diagnosis, serving as the key basis for doctors to assess diseases or conditions, they must be printed on medical (dry) laser films or thermal-sensitive films, which meet higher standards. These films provide better resolution, enhanced image stability, long-term durability, and more precise image representation, all of which are essential for medical imaging in diagnostic contexts.

The introduction of these new regulations aims to ensure the quality and appropriateness of medical imaging materials, preventing any impact on diagnostic accuracy due to the use of substandard or unsuitable recording media. Especially concerning the high precision required for medical images, the revised catalog emphasizes the distinction between diagnostic images and non-diagnostic images, ensuring that the medical field has access to high-quality image records and resources to support reliable clinical decision-making.