Chinese market for Clinical laboratory equipment
We just highlight some strategic hints to enter Chinese market of Clinical laboratory equipment. For further free evaluation fill contact form below. We would like meet you in a meeting with gap analysis.
Product code of Clinical laboratory equipment in China
The product code is 6 digits in China (22-01-01). Determination of product code is essential of classification and others pathway of registration.
Here are all product codes of Clinical laboratory equipment in China:
22-01 Hematology analysis equipment
01 Blood type analysis instrument 02 Blood cell analysis instrument 03 Blood cell morphology analysis instrument 04 Coagulation analysis instrument 05 Platelet analysis instrument 06 Blood rheology analysis instrument 07 Red blood cell sedimentation instrument 08 Flow cytometer
22-02 Biochemical analysis equipment
01 Biochemical analysis instrument 02 Blood glucose and blood glucose related parameter analysis instrument
22-03 Electrolyte and blood gas analysis equipment
01 Electrolyte analysis instrument 02 Blood gas analysis instrument 03 Electrolyte blood gas analysis instrument 04 Electrolyte blood gas detection electrode
22-04 Immunoassay equipment
01 Enzyme-linked immunosorbent assay instrument 02 Chemiluminescent immunoassay instrument 03 Fluorescent immunoassay instrument 04 Immunochromatography analysis instrument 05 Immunoblotting instrument 06 Immunoscattering turbidity analysis instrument 07 Immunoassay integrated machine 08 Indirect immunofluorescence analysis instrument 09 Biochemical immunoassay instrument
22-05 Molecular biology analysis equipment
01 Gene sequencing instrument 02 Sanger sequencing instrument 03 Nucleic acid amplification analysis instrument 04 Nucleic acid amplification instrument 05 Nucleic acid molecular hybridization instrument
22-06 Microbial analysis equipment
01 Microbial turbidimetric instrument 02 Microbial culture monitoring instrument 03 Microbial drug sensitivity culture monitoring instrument 04 Microbial identification instrument (non-mass spectrometry) 05 Microbial mass spectrometry identification instrument 06 Microbial identification drug sensitivity analysis instrument 07 Bacterial endotoxin/fungal glucan detection instrument 08 Helicobacter pylori analysis instrument
22-07 Scanning image analysis system
01 Medical microscope 02 Image scanning instrument 03 Image analysis instrument
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
