Why are there three types of medical devices?

Hunan Pharmaceutical Group specializes in providing integrated services for the transformation, registration, production, and R&D of medical devices, and the service is different: the first category is low risk, the second category is medium risk, and the third type is high risk.

2. The degree of management is different: the first type of routine management can ensure its safety, the second type needs to strictly control the management to ensure its safety, and the third type needs to take special measures to strictly control the management to ensure its safety. 3. Whether it is filed or not is different:

Class I medical devices are subject to product filing management, and Class II and Class III medical devices are subject to product registration management. 4. The submission of information is different: to apply for the registration of Class II medical device products, the registration applicant shall submit the application to the food and drug supervision of the province, autonomous region and municipality directly under the Central Government

Imitation of the FDA in the United States, according to the safety of the classification.

For example, the production of Class III medical devices shall be reviewed and approved by the drug regulatory department, and a product production registration certificate will be issued.

The production of Class II and Class III medical devices shall pass clinical verification.

Three types of medical devices, such as artificial heart valves, artificial joints, vascular stents, hemostatic gauze implanted in the human body, etc.

Note that there are a lot of hemostatic gauze and soluble hemostatic gauze on the market, but only three types can be implanted into the human body and absorbed by the human body, without taking out.

At present, the state adopts strict control and management of the safety and effectiveness of Class III medical devices.

Medical devices are a matter of human life, and it is also a key area of national supervision, but the profit-seeking behavior of some manufacturers has caused a mixture of dragons and snakes in this field, and we advise all operators to pay more attention to the substantive role of the product while seeking profits, and it is absolutely not allowed to exaggerate the role of a product.

Article 5 The state implements classified management of medical devices.

The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The third category refers to implantation in the human body; used to support and sustain life; Medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.

The three categories must be controlled, the risk factor is the highest, and if you don't control it, your life is at stake!

A type of device is an ordinary medical device such as a cotton swab. The second category is non-intrusive devices. Like red and blue light and the like. The third category is interventional devices. Even if it's a gastroscopy. Color ultrasound. There are three types of things that enter the body.

Classified according to the risk level, the first type is low risk and easy to control, such as gauze needles and the like. The third category has higher risks and higher requirements for registration and post-marketing supervision, such as pacemakers, anesthesia machines, ventilators, etc.

When registering and certifying, medical devices are classified according to the risk level, and the registration process for different categories of devices is different, and the specific category of your product belongs to depends on the documents of the Food and Drug Administration.

If you are doing CE certification, the products are also divided into Class I, IIA, IIB and III according to the risk level, depending on MDD

directive

93/42/eec

Annexix determines exactly which category your product falls into based on classification rules.

In accordance with the Regulations on the Supervision and Administration of Medical Devices, the state has classified medical devices according to the degree of risk. Class III medical devices are high-risk medical devices, and Zheng Ku needs to shout Zendong to be registered and approved by the State Food and Drug Administration before it can be produced. For example:

Implantable medical devices.