What are the products of Class II medical devices

Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.

Devices are classified as follows:

Basic surgical instrumentsMicrosurgical instruments

Neurosurgical instrumentsOphthalmic instruments

Otorhinolaryngology surgical instrumentsOral surgical instruments

Thoracic and cardiovascular surgical instrumentsAbdominal surgical instruments

Urologic and anorectal surgical instrumentsArthopaedic (orthopaedic) surgical instruments

Orthopedic surgical instruments

Orthopedic surgical instruments

These are the most important medical devices. Surgical Instruments for Orthopedic Surgery (Orthopedics)

Surgical Instruments for Obstetrics and Gynecology Surgical Instruments for Family Planning Surgical Instruments

Injecting and Puncturing Instruments Surgical Instruments for Burns (Orthopedic) Surgical Instruments

Preparation Instruments for General Diagnostic Instrumentation Medical Electronic Instruments

Medical Optical Apparatus, Instrumentation and Endoscopic Devices Medical Ultrasound Instrumentation and Related Devices

Medical Laser Instruments and Devices Medical High-frequency Instrumentation

Physical therapy and rehabilitation equipment Chinese medicine instruments

Medical magnetic **** vibration equipment medical X-ray equipment

Medical high-energy radiation equipment

Medical nuclide equipment medical ray protection supplies, devices

Clinical test and analysis instruments medical laboratory and basic equipment apparatus

Extracorporeal circulation and blood processing equipment implantable materials and artificial organs

Medical optical instruments and instruments and endoscopic equipment Artificial organs

Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances

Ward care equipment and appliances Disinfecting and sterilizing equipment and appliances

Medical cold therapy, cryotherapy, refrigeration equipment and appliances stomatology materials

Medical hygienic materials and dressings medical suture materials and adhesives

Medical polymer material and Product software

Interventional devices

Legal basis

"Regulations for the Supervision and Administration of Medical Devices (Revised in 2021)"

Article 32 Engaged in the production of Class II and Class III medical devices shall apply to the drug supervision and management department of the people's government of the province, autonomous region, municipality directly under the Central Government for a production license and submit its compliance with the third paragraph of these regulations. License and submit its compliance with the conditions set forth in Article 30 of these Regulations and the relevant information and production of medical devices registration certificate.

To accept the application for production authorization of drug supervision and management department shall review the application information, in accordance with the State Council drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification, and from the date of acceptance of the application within 20 working days to make a decision. To meet the prescribed conditions, permission is granted and issued to the medical device production license; does not meet the prescribed conditions, not licensed and a written explanation of the reasons.

Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.