30 batches of medical devices have been refused to enter the Chinese market - Regulatory News - Medical Devices

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

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