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

1. Diagnostic Devices:

   • In vitro diagnostic devices (IVDs), such as blood glucose meters and PCR test kits.
   • Imaging equipment, like X-ray machines and MRI systems.

2. Therapeutic Devices:

   • Surgical instruments (e.g., scalpels, forceps).
   • Implantable devices, such as stents and pacemakers.

3. Monitoring Devices:

   • Patient monitoring systems (e.g., ECG monitors, vital signs monitors).
   • Wearable health devices (e.g., heart rate monitors).

4. Consumables:

   • Single-use products like syringes, needles, and surgical gloves.
   • Diagnostic reagents and kits.

5. Assistive Devices:

   • Prosthetics and orthotics (e.g., artificial limbs, braces).
   • Mobility aids, like wheelchairs and walkers.

6. Therapeutic Equipment:

   • Devices for physical therapy, such as ultrasound therapy machines.
   • Home healthcare devices, including nebulizers and oxygen concentrators.

7. Software as a Medical Device (SaMD):

   • Medical software applications for diagnosis or treatment.

These categories cover a wide range of products, all requiring compliance with specific regulatory standards for safety and efficacy before being approved for market access in China.

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