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January 1, 2018, the medical device manufacturers will fully implement the GMP management system

Release time:2015/11/08 news Times of browsing:1058

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January 1, 2018, the medical device manufacturers will fully implement the GMP management system

August 17, Beijing Food and Drug Administration issued a notice on the effective implementation of medical device quality management practices, once again remind everyone that since January 1, 2018, all medical devices and in vitro diagnostic reagents companies have to implement GMP management system.

 

From 136 days left on January 1, 2018, are you ready for three months or so left of the holidays?

 

According to the requirements of the “State Food and Drug Administration Circular on the Implementation of Quality Management Practices for Medical Device Manufacturing” (No. 15 of 2014), the schedule of GMP implementation is as follows:

 

Quality Management Regulatory Scope Execution Time

GMP

(Medical Device Production Quality Management) Sterile and Implantable Medical Devices January 1, 2011

– New medical equipment manufacturing enterprises

– Existing medical device manufacturers increase the production of the third type of medical devices and relocate or increase the production sites on October 1, 2014

The third type of medical device production January 1, 2016

All medical devices and in vitro diagnostic reagents production January 1, 2018

In other words, the first type II medical device manufacturer that started before October 1, 2014 is currently without GMP implementation. Here, Ruixu technology remind these companies, GMP inspection is not a trivial matter, enterprises should make preparations as soon as possible, in accordance with the “medical device manufacturing quality management practices,” the requirements of self-inspection, improve the quality management system.

 

Although the full implementation of GMP will come into force on January 1, 2018, the GMP verification will certainly be conducted before that time, so it is actually not much time left for the enterprise.

 

Enterprises in the GMP verification must not be lucky, in November 2015, Zhejiang Province, GMP verification of three types of enterprises, 36 companies passed only one inspection. The state pays more and more attention to the post-market supervision of medical devices, while quality management and risk management are the main measures to ensure the quality and safety during the product life cycle and also the focus of the future supervision of medical devices.

CIRS has also compiled some suggestions on GMP establishment and audit, enter the public number home page, click on the “GMP” sub-menu under the “wonderful review” certification, you can view the GMP-related content.

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