Disposable hygiene materials belong to several categories of medical devices

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.

Extended Information: Requirements for the Use of Disposable Hygiene Materials:

1. Establish a system for destroying sterile instruments after use. Used sterile instruments must be destroyed in accordance with regulations, and parts that no longer have the function of use shall be disinfected and harmless, and recorded.

2. Establish a procurement and acceptance system for sterile instruments, strictly implement and make records. The purchase acceptance record should at least include: the enterprise name, product name, model specification, product quantity, production batch number, sterilization batch number, product expiration date, etc.

3. If unqualified sterile instruments are found, they should be stopped and sealed immediately, and the manufacturer should be contacted in time to replace them. When a suspected adverse event occurs in the use of sterile instruments, it should be reported to the Provincial Medical Device Adverse Event Monitoring Center in a timely manner according to the regulations.

Disposable surgical kits belong to the second class of medical devices, and their scope of use is: for medical institutions to operate on patients. Production conditions: product registration certificate, production license. Business conditions: Class II business record certificate.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray machine, B-ultrasound, microscope, biochemical instrument, etc., all belong to the second class of medical devices.

Extended information: The following conditions must be met to start a Class II medical device manufacturer:

1. The person in charge of the enterprise should have a technical secondary school degree or above or a junior professional title.

2. The person in charge of the quality inspection agency should have a college degree or above or an intermediate title or above.

3. The engineering and technical personnel with junior titles or above in the enterprise should occupy the corresponding proportion of the total number of employees.

4. Enterprises should have the corresponding product quality inspection capabilities.

5. There should be a production and storage site and environment that match the products and scale of the production.

6. It has corresponding production equipment.

7. The enterprise shall collect and keep the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.

7. For the production of sterile medical devices, there should be a production site that meets the regulations.

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.

Basic Surgical InstrumentsMicrosurgical Instruments.

Neurosurgical Instruments, Ophthalmic Surgical Instruments, Talking about Spring Instruments.

Otolaryngology Surgical InstrumentsOral Surgical Instruments.

Thoracic cardiovascular surgical instruments, abdominal surgical instruments.

Urorectal Surgical Instruments, Orthopedic (Orthopedic) Surgical Instruments.

Surgical instruments for obstetrics and gynecology and family planning surgical instruments.

Injection and puncture instruments, surgical instruments for burn (plastic) surgery.

General diagnostic equipment, medical electronic instruments and equipment.

Medical optical instruments, instruments and endoscopic equipmentMedical ultrasound instruments and related equipment.

Medical laser instruments and equipment, medical high-frequency instruments and equipment.

Physics**and**equipmentTraditional Chinese medicine equipment.

Medical magnetic resonance equipment, medical X-ray equipment.

X-ray ancillary equipment and components for medical royal oranges, medical high-energy radiation equipment.

Medical nuclide equipment, medical radiation protection equipment, devices.

Clinical laboratory analysis instruments, medical laboratory tests and basic equipment and appliances.

Cardiopulmonary bypass and blood processing equipment, implanted materials and artificial organs.

Operating room, emergency room, diagnosis and treatment room equipment and equipment, dental equipment and appliances.

Ward nursing equipment and utensils, disinfection and sterilization equipment and appliances.

Medical cold therapy, low temperature, refrigeration equipment and appliances dental materials.

Medical hygiene materials and dressings, medical suture materials and adhesives.

Medical polymer materials and products interventional equipment.

If it is a disposable sterile sanitary material, it basically belongs to the second class of medical devices.

For example, sterile cotton swabs, sterile cotton balls, etc. are the second category.

Instead of sterile bandages, adhesive tapes are Class I medical devices.

Legal analysis: The catalogue of medical devices for one-time use shall be formulated, adjusted and published by the food and drug supervision and administration department in conjunction with the competent health and family planning department.

Legal basis: Social Insurance Law of the People's Republic of China

Article 4 Employers and individuals within the territory of the People's Republic of China who pay social insurance premiums in accordance with law have the right to inquire into the records of payment and personal rights and interests, and to request the social insurance agencies to provide social insurance consultation and other related services.

Individuals enjoy social insurance benefits in accordance with the law, and have the right to supervise their own units' contributions for them.

Article 5: The people at or above the county level shall include social insurance undertakings in their national economic and social development plans.

The state raises social insurance funds through multiple channels. The people at or above the county level shall give necessary financial support to the social insurance undertakings.

The state supports the social filial piety insurance industry through preferential tax policies.