What types of products are applicable for medical device registration in China?
分类:行业新闻 发布时间:2024-10-22 15:51:16
These products must meet specific regulatory requirements to ensure safety and efficacy before market approval.

In China, the following types of products are applicable for medical device registration:

  1. Surgical Instruments: Tools and devices used in surgical procedures, such as scalpels, forceps, and surgical drapes.

  2. Diagnostic Devices: Equipment for diagnosing diseases, including imaging devices (X-rays, MRIs) and diagnostic tests (blood glucose monitors).

  3. Therapeutic Devices: Devices intended for treatment, such as infusion pumps, dialysis machines, and orthopedic implants.

  4. Monitoring Equipment: Devices that track patient health, including heart monitors, blood pressure monitors, and multi-parameter monitors.

  5. Dental Devices: Instruments and materials used in dental care, such as dental chairs, imaging equipment, and prosthetics.

  6. Medical Software: Software intended for medical purposes, including applications for managing patient data or aiding in diagnosis.

  7. In vitro Diagnostic Devices: Products for testing biological samples outside the body, like laboratory reagents and test kits.

  8. Personal Protective Equipment (PPE): Items designed to protect users from health risks, such as masks, gloves, and gowns.

These products must meet specific regulatory requirements to ensure safety and efficacy before market approval.

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