CFDA’ s Oversea Medical Devices Inspections Upgraded

From April 24^th to 28^th 2017, CFDA was having the special training for their oversea medical devices inspectors. Through learning international regulations, the audit methods and skills from the third party and discussing their own experience, the inspectors promoted their capability on how to proceed with the GMP auditing for oversea medical devices manufacture. And according to achievement of the oversea medical devices inspections in 2015 and 2016, vice president Lei Sun highly admired the performance of the oversea medical devices inspectors. At the same time, he came out with the new expectations:

Keep improving the preparation before the inspections and the emergency situation report system during the inspections. And the audit systems for rectify and reform and the following regulation system also need to be upgraded.
Perfect the comprehensive capability of our inspectors.
Continually explore the inspection methods for the existing products and new products.

CFDA Regulation History

March 14^th 2001, CFDA issued the Imported Medical Device Manufacturer Quality System Inspection Implementation Regulation ( http://www.sda.gov.cn/WS01/CL0059/9375.html).
December 2^nd 2015, CFDA, the first time, organized oversea medical device manufacturer GMP on-site inspection (http://www.sda.gov.cn/WS01/CL0051/136643.html).

For the past few years, CFDA is getting more serious with the oversea medical devices’ quality, safety and legitimacy. Chinese inspectors keep improving their comprehensive abilities. The oversea medical devices inspection system becomes stricter in 2017. In order to be more compatible in the Chinese market, international medical device companies should not only keep eye on their products’ quality and advancement but also continually updating the knowledge of new Chinese medical devices regulations.
List of the Oversea Medical Devices Regulations

ISO 13485:2016 INTERNATIONAL STANDARD---The international standard of medical device quality management system for regulation requirement, general regulation in China.
2017 Medical Device Quality Management System Used for Regulation Requirement ----The detailed version of regulation based on ISO 13485:2016, more recommended for the international companies.
Medical Device Good Manufacturing Practice---CFDA Mandatory standard for the general medical device inspections.
Medical Device Good Manufacturing Practice-Implant Medical Device---CFDA Mandatory standard for the Implant Medical Device inspections
Medical Device Good Manufacturing Practice-Implant Medical Device On-site Inspection Guideline----CFDA implant medical device on-site inspection guideline

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