At the end of September, AQSIQ announced the unqualified information of imported industrial products in August 2017, Including 30 batches of medical devices.
The most unqualified reason is "No medical device registration certificate or record certificate”. These nonconforming products have been destroyed or returned to the disposal, failed to enter the Chinese market.
Produce Name | Brand | Origin | Reasons for Disqualification |
External Ear Orthopedic Implant Clamping System | CONTRACT | GER | No medical device registration certificate or record voucher |
Syringe, Needle | Denmark | ||
Infusion Tube | Malta | ||
Syringe | JAP | ||
Syringe | Singapore | ||
Lung function instrument | GER | ||
Plastic Tubing | Ireland | ||
Anesthetic Gas Module for Anesthesia Machine | GER | ||
Blade | Gebauer | GER | |
Balloon Catheter | USA | ||
Left Atrial Appendage Occluder | USA | ||
Infusion Bag, Infusion Tube | USA | ||
Guide Sheath Attachment | USA | ||
Biopsy Needle | medax | Italy | |
High-frequency Electric Knife, High-frequency Electric Knife Accessories | GER | ||
Mainstream Multi-gas Detection Module | Sweden | ||
X-Ray Spherical Tube | USA | ||
Automatic Single Level Breathing Machine | ResMed | Australia | |
Suture Needle | JAP | ||
Angiography Catheter | Mexcio | ||
Angiography Catheter | Mexcio | ||
Non-contact Pressure Gauge | Taiwan | ||
Deep Penetrating Heat Treatment Instrument | Italy | ||
Sphygmomanometer | DHL | France | Medical Device registration Certificate not available |
Automatic Freezer Dyeing Machine | MILESTONE | Italy | Failed to provide medical device registration certificate or filing Certificate |
All-in-one Machine | portwell | Taiwan | Non-GB power cord is not compatible with 3c certificate conformance requirements |
Defibrillation Monitor | INNOMED | Hungary | The address and product model on the label of the product are inconsistent with the registration certificate |
Platelet-rich Plasma Preparation Device | KR | The locking lever of the red cell in the device is not sealed, which causes the red cell storehouse to close. This resulted in the separation of erythrocyte reflux. The size of the locking rod is error, which belongs to the manufacturing problem. | |
Massage Chair | FUJI | China | The device uses a voltage of 110V, which is inconsistent with China's voltage system |
X-Ray Spherical Tube | SIEMENS | China | Non-Chinese manuals and production inspection reports and other related documents |