Regarding the regulations on expectoration machines, here is a summary in English:

Sharing of Regulations on Expectoration Machines:

The regulations concerning expectoration machines, also known as vibrating chest physiotherapy devices, involve multiple legal frameworks and directives to ensure the safety, effectiveness, and quality of these products in their respective markets.

1. Medical Device Regulation (MDR)
   Regulation Number: Regulation (EU) 2017/745
   Scope: Applies to all medical devices, including expectoration machines.
   The MDR stipulates the basic requirements for medical devices, such as safety, effectiveness, performance, and user information. Devices are classified based on their risk level (e.g., Class IIa or IIb). Manufacturers must provide clinical data or conduct clinical trials to demonstrate the safety and effectiveness of their products. Detailed technical documentation, including product descriptions, risk management, clinical data, and user manuals, must be compiled. A quality management system conforming to ISO 13485 is required.

2. Low Voltage Directive (LVD)
   (Though not explicitly mentioned in the context of expectoration machines, it is generally applicable to electrical equipment.)
   Scope: Applies to electrical equipment to ensure safety during use.
   Devices must undergo electrical safety testing to ensure safety under normal and fault conditions. The design and manufacture of the devices must comply with electrical safety standards.

3. Electromagnetic Compatibility Directive (EMC)
   Directive Number: 2014/30/EU
   Scope: Applies to all electrical and electronic equipment to ensure proper operation in electromagnetic environments without interfering with other devices.
   Devices must possess appropriate electromagnetic compatibility to prevent interference with other equipment and must be able to withstand a certain level of electromagnetic interference to ensure normal operation.

4. Medical Device Standards
   Standards such as ISO 13485 (quality management systems), ISO 14971 (risk management), and ISO 10993 (biocompatibility) provide requirements for the design, manufacture, testing, and quality management of medical devices. Manufacturers must comply with these international standards and prepare corresponding documentation.

5. CE Marking
   Devices must be marked with the CE symbol, indicating compliance with all relevant EU regulations.

6. User Manuals and Compliance Declarations
   Detailed user manuals, including instructions for use, safety warnings, and maintenance information, must be provided. A Declaration of Conformity must be prepared and submitted, stating that the device complies with all applicable EU regulations and directives.

7. Post-Market Surveillance
   Manufacturers must implement post-market surveillance programs to collect user feedback and address adverse events.

For markets in China, the registration of expectoration machines with the National Medical Products Administration (NMPA) is mandatory. All medical devices, including expectoration machines, sold and used in China must undergo NMPA registration approval. Manufacturers must prepare corresponding registration materials, including technical documents, performance test reports, and biocompatibility test reports, and submit them to the NMPA for review.

In summary, the regulations for expectoration machines involve multiple legal frameworks and standards, aiming to ensure the safety, effectiveness, and quality of these devices in the market. Manufacturers must comply with these regulations to ensure that their products can be legally sold and used.