Drugdu.com expert's response:

Operating Class I medical devices does not require filing. This conclusion is primarily based on the following points of evidence and explanations:

I. Classification Management of Medical Devices

According to the "Regulations on the Supervision and Administration of Medical Devices" and related regulations, medical devices are classified into Class I, Class II, and Class III based on their risk levels, from low to high. Different categories of medical devices have varying management requirements in terms of operation and production.

Class I medical devices: These are medical devices with a low risk level, and their safety and effectiveness can be ensured through routine management. These devices typically have simple structures and are easy to operate, such as surgical knives, surgical scissors, gauze bandages, and other basic medical supplies.

Class II medical devices: These are medical devices with a moderate risk level that require strict control management to ensure their safety and effectiveness. These devices are typically used for auxiliary diagnosis or treatment, such as thermometers, blood pressure monitors, and medical masks.

Class III medical devices: These are medical devices with a high risk level that require special measures for strict control management to ensure their safety and effectiveness. These devices are typically used for implantation in the human body or to support and maintain life, such as cardiac pacemakers, artificial joints, and vascular stents.

II. Management Requirements for Operating Class I Medical Devices

No permit or filing required: Operating Class I medical devices does not require obtaining a medical device operation permit or undergoing filing procedures. This is because Class I medical devices have a low risk level, and routine management is sufficient to ensure their safety and effectiveness.

Establish management systems: Despite not requiring a permit or filing, enterprises operating Class I medical devices must still establish and implement systems for incoming goods inspection records and sales records to ensure the quality and safety of the medical devices they operate.

Meet operational conditions: Enterprises operating Class I medical devices should have operational premises and storage conditions appropriate for their scale and scope of operations, as well as quality management systems and quality management personnel or organizations appropriate for the medical devices they operate.

III. Filing Requirements for Producing Class I Medical Devices

Although operating Class I medical devices does not require filing, producing Class I medical devices requires submitting filing materials to the drug supervision and administration department of the municipal people's government at the district level where the enterprise is located to complete product filing. The filing materials include product risk analysis documents, product technical requirements, product inspection reports, clinical evaluation documents (if applicable), product instructions and label samples, quality management system documents related to product development and production, and other materials required to prove the safety and effectiveness of the product.

IV. Supervision and Penalties

Supervision measures: The drug supervision and administration department conducts routine inspections of enterprises operating Class I medical devices to ensure they comply with relevant regulations.

Penalty measures: If an enterprise operating Class I medical devices violates relevant regulations, such as failing to establish and implement systems for incoming goods inspection records and sales records, the drug supervision and administration department will impose penalties in accordance with the law, including warnings and fines.