Chinese market for Medical software
We just highlight some strategic hints to enter Chinese market of Medical software. For further free evaluation fill contact form below. We would like meet you in a meeting with gap analysis.
Product code of Medical software in China
The product code is 6 digits in China (21-01-01). Determination of product code is essential of classification and others pathway of registration.
Here are all product codes of Medical software in China:
21-01 Treatment planning software
01 Radiotherapy planning system software 02 Radiotherapy auxiliary software 03 Surgical planning software
21-02 Image processing software
01 Medical image storage and transmission system software 02 Medical image processing software
21-03 Data processing software
01 Monitoring software 02 Physiological signal processing software
21-04 Decision support software
01 Drug calculation software 02 Computer-aided diagnosis/analysis software 03 Traditional Chinese medicine diagnosis and treatment software
21-05 In vitro diagnostic software
01 Medical microscopic image analysis software 02 Screening and analysis software
21-06 Others
01 Rehabilitation training software
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
