Chinese market for Medical rehabilitation equipment
We just highlight some strategic hints to enter Chinese market of Medical rehabilitation equipment. For further free evaluation fill contact form below. We would like meet you in a meeting with gap analysis.
Product code of Medical rehabilitation equipment in China
The product code is 6 digits in China (19-01-01). Determination of product code is essential of classification and others pathway of registration.
Here are all product codes of Medical rehabilitation equipment in China:
19-01 Rehabilitation equipment for cognitive speech and hearing disorders
01 Rehabilitation equipment for cognitive disorders 02 Visual rehabilitation equipment 03 Auditory rehabilitation equipment 04 Rehabilitation equipment for speech disorders 05 True ear tester 06 Speaker aid 07 Hearing aid
19-02 Sports rehabilitation training equipment
01 Gait training equipment 02 Rehabilitation training bed 03 Balance training equipment 04 Vibration training equipment 05 Joint training equipment 06 Pelvic floor muscle training equipment 07 Tongue muscle rehabilitation trainer
19-03 Walking aids
01 Medical wheelchair 02 Auxiliary walking and standing equipment
19-04 Orthopedic fixation equipment
01 Orthosis 02 Fixation device
Product specific guidance and standards (for payed clients)
Other registration elements
Type testing is one third of Chinese registration. Starting with product technical requirment (PTR), overcoming trouble shoooting at locla testing and ending with testing report.
There are risk based clinical approach in China:
CER based on exemption catalog
CER based on equivalent or similar devices
CER with accepted overseas clinical study
Clinical study in China
Description Title
Time and cost matter for market access. There are clear defined registration cost and review time in China.
Significant change is as a mythos in CHina because a change guidance is missing. Be smart with us to actively manage design change.
Post market surveillance is extensive in EU however straightforward in China
