What Are the Different Types of Medical Instruments?

The state has a strict classification of medical devices, and the three types of medical devices are the highest-level medical devices, and they must also be strictly controlled. They are implanted in the human body to support and sustain life. Medical devices whose safety and effectiveness must be strictly controlled.

Three types of medical equipment

The country has a strict classification of medical devices, and three types

I. List of materials required to apply for three types of medical devices:

(1) Copy of business license and organization code certificate;
(2) A copy of the registration certificate and product technical requirements of the medical device produced held by the applicant enterprise;
(3) A photocopy of the identity certificate of the legal representative and the person in charge of the enterprise;
(4) A photocopy of the identity, education, and title of the person in charge of production, quality, and technology;
(5) A list of educational backgrounds and titles of employees in production management and quality inspection positions;
(6) The certification documents of the production site, if there are special production environment requirements, a copy of the certification documents of the facilities and the environment shall also be submitted;
(7) Catalogue of main production equipment and inspection equipment;
(8) Quality manuals and procedure documents;
(9) Process flow chart;
(10) Certificate of authorization of the handler;
(11) Other supporting materials. ^[1]

The production of the second and third types of medical devices should pass clinical verification. For example, the production of Class III medical devices shall be examined and approved by the drug regulatory department of the State Council, and a product registration certificate shall be issued.

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

Note that there are many hemostatic gauze and soluble hemostatic gauze on the market, but only three types can be implanted in the human body, absorbed by the human body, and do not need to be removed. Used in the body, but it is not in compliance with the law and is prone to problems.

At present, the state strictly controls the safety and effectiveness of the third type of medical devices.

Medical equipment is a life-threatening matter and a key national regulatory area. However, the profit-making behavior of some manufacturers has led to a mix of dragons and snakes in this area. We urge all operators to pay more attention to the essential role of products while profiting. Never exaggerate the effects 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 medical devices implanted into the human body; used to support and sustain life; potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled.