Is Environmental Impact Assessment Required for Mobile DR Medical Equipment?

 Recently, many customers have called to consult about Puai Medical's mobile DR products, and raised a question: "Do hospitals need to conduct an environmental impact assessment (EIA) when purchasing mobile DR equipment?"

Under normal circumstances, an EIA and filing are required for mobile DR medical equipment; however, the state has exemption policies for specific emergency situations.

I. Normal Circumstances: EIA Must Be Conducted

In the regular medical market environment, mobile DR falls into the category of Class III radiation-emitting devices. In accordance with the Environmental Impact Assessment Law of the People's Republic of China and the Regulations on the Safety and Protection of Radioactive Isotopes and Radiation-emitting Devices, entities that produce, sell, or use radiation-emitting devices must compile an environmental impact assessment document before applying for a radiation safety license.

1. Forms of EIA

The radiation hazards associated with mobile DR are generally classified as "general type". Unlike radiotherapy equipment, which requires a complex Environmental Impact Statement, mobile DR typically only needs the completion and filing of the Environmental Impact Registration Form for Construction Projects.

2. Reasons for Mandatory EIA

Although mobile DR is "mobile", its places of use (such as ICU wards, emergency rooms, and operating rooms) must meet radiation protection requirements. The purpose of the EIA is to assess whether the protective thickness of walls, doors, and windows in these usage locations meets the standards, and whether the radiation dose in the surrounding environment is within the safe range.

II. Special Circumstances: Exemption from EIA (Emergency Policy)

There is one scenario where EIA can be temporarily waived, namely during public health emergencies such as epidemic prevention and control.

According to the notice issued by the Ministry of Ecology and Environment in 2020 (Letter No. [2020] 51 of the Radiation Department of the Ministry of Ecology and Environment), during the period of epidemic prevention and control, medical institutions that urgently add equipment such as CT scanners, vehicle-mounted CT scanners, and mobile DR for diagnostic purposes may be exempted from the formalities of environmental impact assessment and radiation safety licensing.

Note: This is a temporary policy. Once the epidemic ends or the emergency status is lifted, if the equipment needs to continue to be used, the relevant EIA and licensing formalities must be completed in accordance with regulations.

III. EIA Process for Mobile DR

If your institution needs to introduce mobile DR under normal circumstances, the EIA process usually includes the following steps. Although the government affairs procedures vary slightly from region to region, the core logic remains consistent.

Step 1: Verify that the Use Location Meets Protection Standards

Before filling in the form, the "hardware" must be in place first. Although mobile DR is flexible, the areas where it is parked and operated (machine rooms or specific wards) must have radiation protection capabilities.

• Machine Room Requirements: The walls, doors, and windows must meet the lead equivalent protection standards (usually implemented through protective decoration by professional companies).
• Monitoring Report: Engage a qualified third-party testing agency to conduct radiation environment monitoring on the machine room and issue a Radiation Environment Monitoring Report. This serves as an important basis for EIA filing.

Step 2: Log in to the Filing System and Fill in the Form

Currently, the EIA registration form is mainly filed online.

Step 3: Submit and Print the Form

After saving and submitting the form, the system will generate a filing form. It needs to be printed out, signed personally by the legal representative (hospital director or legal representative), and affixed with the official seal of the entity.

Step 4: Follow-up Procedures

EIA filing is only the first step, which prepares for the next step of applying for the Radiation Safety License.

Submit the filing form, monitoring report, equipment information, personnel training certificates, and other materials to the municipal-level ecology and environment department to apply for the radiation safety license.

Only after obtaining the license can the equipment be officially put into use.

Suggestions from Mobile DR Manufacturers: Do not neglect the EIA just because the equipment is "mobile". When mobile DR is used for bedside radiography, if the surrounding personnel (such as other patients and medical staff) are not effectively protected and warned, radiation-related disputes are more likely to occur. Therefore, completing the EIA filing and clearly defining the controlled areas and supervised areas is the best protection for both the hospital and patients.