What are the three certificates for disposable medical devices?

The three certificates refer to: medical device manufacturer license, medical device business license, and quasi-brand medical device registration certificate.

The medical device production license is a certificate that must be held by medical device manufacturers, which is reviewed and issued by the local food and drug administration. The establishment of medical device manufacturing enterprises shall be in line with the national medical device industry development plan and industrial policy.

The medical device business license is a document that must be possessed by medical device business enterprises, and the establishment of a second-class medical device business enterprise shall be filed with the people's drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government; The establishment of a Class III medical device business enterprise shall be reviewed and approved by the people's drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government, and the "Medical Device Business Enterprise License" shall be issued.

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to agree to their sale and use.

It is divided into domestic medical device registration and overseas medical device registration, whether it is a class, a class, a class three of medical devices to the Beijing State Food and Drug Administration: domestic class I and class II medical devices in the local provincial or municipal food and drug administration, class III to the State Food and Drug Administration. The medical device registration certificate refers to the legal ID card of medical machinery products.

Catalogue of Class III medical devices under national key monitoring.

1. Disposable sterile medical equipment shed manuscript equipment.

1. Disposable sterile syringe;

2. Disposable infusion set;

3. Disposable blood transfusion set;

4. Disposable anesthesia puncture kit; Sun Dan.

5. Disposable intravenous infusion needle;

6. Disposable sterile injection needle; then and scramble.

7. Disposable plastic blood bags;

8. Disposable blood collection device;

9. Disposable burette infusion set.

The requirements for the three types of medical device certificates are: 1. Site requirements: it must be office in nature, and the usable area must be at least 45 square meters; 2. Personnel requirements:

It is necessary to have 3 relevant personnel (company leader, quality director, quality inspection personnel) for the record and hold certificates; 3. Product requirements: there must be product information that conforms to the scope of business, and a certificate must be issued; 4. Other relevant laws and regulations. In accordance with the relevant laws and regulations, if a person practices without obtaining a medical institution's practice license, the relevant health department will impose corresponding penalties on the illegal medical institution according to the circumstances.

Article 99 of the Law of the People's Republic of China on Basic Medical Care and Health Promotion: Whoever violates the provisions of this Law by practicing without obtaining a practice license from a medical institution, shall be ordered by the competent health department of the people's ** at or above the county level to stop practicing activities, confiscate illegal gains, drugs and medical devices, and impose a fine of between 5 and 20 times the amount of illegal gains, and where the illegal gains are less than 10,000 yuan, it shall be calculated as 10,000 yuan. Whoever violates the provisions of this law by forging, altering, buying, selling, renting, or lending a medical institution's practice license shall be ordered to make corrections by the competent department of people's health at or above the county level, confiscate the unlawful gains, and impose a fine of between 5 and 15 times the unlawful gains, and where the unlawful gains are less than 10,000 yuan, it shall be calculated as 10,000 yuan; where the circumstances are serious, revoke the medical establishment's practice license.

Disposable sanitary materials belong to medical sanitary materials and dressings; It belongs to Class II medical devices.

Class II medical devices mainly include: operating room, emergency room, diagnosis and treatment room equipment and appliances; dental equipment and appliances; Ward nursing equipment and appliances; disinfection and sterilization equipment and utensils; medical cold therapy, low temperature, refrigeration equipment and appliances; dental materials; medical and sanitary materials and dressings; medical suture materials and adhesives; medical polymer materials and products; Software; Interventional equipment, etc.

To engage in medical device business activities, there shall be business premises and storage conditions suitable for the scale and scope of business, as well as quality management systems and quality management institutions or personnel suitable for the medical devices operated.

In our Jilin Province, the three certificates that should be reviewed for disposable sterile medical devices refer to: enterprise business license, enterprise production license, and enterprise product registration certificate. It is also known as two certificates and one license.