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China Implements GUP (Good Use Practice) on Medical Device

from CIRS by


On Oct 23th, 2015, China Food and Drug Administration (CFDA) has promulgated Administrative Measures for Quality Supervision on the Use of Medical Devices to strengthen the management of the use of medical devices. As we all know, the use of medical device is an important activity in the integrated supply chain management, and the quality and the integrity of medical device can be affected by a lack of adequate control.

According to the regulation, medical device use parties shall equip quality control (QC) department or personnel suitable for the scale, and establish QC system for use of medical device. What is more, medical device production and management enterprise shall provide after-sales service, direct and coordinate the quality management carried out by use department.
The quality management includes two aspects; one involves purchase, acceptance check and storage; another one involves use, maintenance and transfer.

1. Purchase, Acceptance check and Storage.

At first, medical device use parties shall manage the purchase of medical device uniformly, and review the qualification of suppliers. What is more, they also shall check the qualified certificate of the product on site, and has a complete record system for purchase and acceptance check.

The medical devices shall be stored and checked regularly according to the requirements of storage condition, expiry, etc.

Note:
Medical device use parties cannot buy and use the medical device those without registration/record certificate, or qualified certificate, as well as overdue, invalid or obsolete medical device.

2. Use, Maintenance and Transfer.

Medical device use parties shall establish quality inspection system before use, usage and maintaining record to ensure the product can be used normally.

Use parties can claim production and management enterprise to provide maintenance service for medical device or the necessary materials and information for maintenance, such as maintenance manual, service manual, software backups, and so on. If production and management enterprise do not provide the above document, they will face the relevant penalty. Serious violators will be fined RMB 2000~20000.

If use parties want to transfer or donated the medical device to each other, they shall guarantee the safety and effectiveness of medical device, and provide the qualified certificate which is issued by qualified inspection institutions.

The medical device without registration/record certificate, or qualified certificate, cannot be transferred and donated, as well as overdue, invalid or obsolete medical device.

If use department do not manage, use and maintain the product as following situation, they will face the relevant penalty.

1)Using medical device without registration/record certificate, or qualified certificate;

2)Do not establish and execute complete record system for purchase and acceptance check;

3)Do not establish and save use record for implant and invasion medical device, and so on.

By the implementation of Administrative Measures for Quality Supervision on the Use of Medical Devices in china, oversea manufactures who want to sell their product in China shall pay more attention while they are choosing their Chinese agent or distributor.

The Chinese agent or distributor shall conform to the following condition.

1)There are rational organization structure and manpower resource.

2)They have established and implemented quality control system and keep the relevant record.

3)They shall equip after sale service personnel and condition which shall match the scale and range of operation, and so on.


  

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