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
Considering entry to the China market, or already in China but finding it a struggle? Our bilingual experts can support your China compliance needs. We support strategy, Type Testing, Clinical Evaluation, CFDA submissions, postmarket compliance and reimbursement. Contact us for a free, no obligation discussion. Email firstname.lastname@example.org or call +61 2 9906 2984 (Sydney) or +86 186 0062 2341