Mechanical products belong to the category of medical devices, must obtain the appropriate medical device registration certificate or record certificate, after the audit to market sales. If you don't have the relevant certificates, unauthorized sales will constitute a violation of the law.
The questions and answers on the mechanical products are as follows:
1, the types of mechanical products: mechanical products are a wide range of products, including medical imaging equipment, surgical instruments, testing instruments, syringes, hemodialysis equipment, etc. Different types of products have different uses. Different kinds of products have different scope of use and applicable objects.
2, the registration process of the device name products: the registration of the device name products need to go through a rigorous review and approval process, including product research and development, clinical trials, reporting registration and other links. In the registration process, it is necessary to provide sufficient evidence and materials to prove the safety, effectiveness and quality of the product and other aspects.
3, the market supervision of the mechanical products: After the mechanical products are listed on the market, they need to be subject to market supervision, including product quality monitoring, adverse reaction monitoring, market access license management, etc.. If the product is found to have safety hazards or quality problems, the relevant departments will take appropriate measures to recall the product, stop production and other processing.
4, the use of mechanical products Note: The use of mechanical products need to comply with the relevant instructions and precautions, can not be arbitrarily replaced, modified or *** use. At the same time, in the process of use also need to pay attention to product maintenance and maintenance to ensure the safety and effectiveness of the product.
To summarize, the device is a strictly audited and approved medical device product, which has a certain degree of safety and effectiveness. The public need to comply with the relevant instructions and precautions when using the device-named products to ensure the safety and effectiveness of the products. The government and relevant departments should also strengthen the supervision and management of the device products to protect the legitimate rights and interests of the public and social harmony.
Legal basis:
"The Chinese people*** and the State supervision and management of medical equipment business" Article 12
Engaged in the operation of the second class of medical devices, the business enterprise shall be located in the municipal food and drug supervision and management department for the record, fill in the record of the second class of medical equipment business form, and submit the information specified in Article 8 of these measures.