Medical devices manufacturer as well as other firms involved in the distribution of medical devices must follow the appropriate requirements and regulations once their product placed on Chinese market. The post-market obligations in China shall include inspection and supervision, advertisement approval, adverse events monitoring, clinical data gathering and reporting, quality management system maintenance, product recall and annual reporting.
CIQ inspection and supervision of imported devices
Medical devices must be subject to AQSIQ regulation-“The Management Measures for Imported Medical Device Inspection and Supervision (AQSIQ order No. [2007] 95)” when imported. The provincial CIQs governed by AQSIQ are the inspection and supervision authorities to manage the imported medical devices, the main managing measures are:
- Classification management and record-keeping of medical device importers
- Inspection and supervision of imported medical devices
- Risk alert and emergency response
The medical device importers are classified as three types (type I, II and III) depending on their management measures, integrity, risk of product, quality and amount of imported. The medical devices are also classified as three types (A: high risk, B: moderate risk, C: general risk).
There are different inspection requirements for each type of importer as well as medical device as follows:
|
Type of
importer
|
Type of medical device |
On-site inspection rate
|
||
| A: high risk | B: moderate risk | C: general risk | |
| Type I | > 50% | > 30% | > 10% |
| Type II | Each batch | > 50% | > 30% |
| Type III | Each batch | Each batch | > 50% |
How to confirm the type of product under AQSIQ regulations
Type A: high risk medical devices
- Implantable medical devices
- Active interventional medical devices
- Medical devices used for supporting and maintaining life
- Medical imaging and energy treatment devices with potential risk to human body
- Medical devices with safety or quality event to be strictly controlled
- Passive interventional medical devices
- Other active contacting medical devices not belong to high risk devices
- Medical devices with safety or quality event to be controlled
Type C: General risk medical devices other than type A and B
The catalog of high risk medical devices will be issued and adjusted by AQSIQ according to the “Management Measures for Imported Medical Device Inspection and Supervision” (AQSIQ order No. [2007] 95). The first version of catalog of high risk medical devices can be found here.
