On 17th May 2017, China FDA published a draft ‘Exemption List of Local Clinical Trial for Class II & Class III medical devices’. This is open for industry and user feedback with a deadline of 20th June 2017.
This will be the 3rd wave exemption list in China.
This further extension of the exemptions will be good news for the manufacturers of dental and orthopaedic (mainly fracture fixation) devices.
Six Class III devices and twenty-two Class II devices were included.
Class II Devices:
- Dental instruments and materials
- Endoscopic surgical instruments
- Insulin Pen injectors
- Gynaecology devices
- Electronic endoscopic image processor
Class III devices:
- Orthopaedics devices including bone screws, Titanium acetabular cups and fracture plates. (3D printed devices are NOT included in the exemption list).
- Needleless connector for indwelling catheter
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