By Stewart Eisenhart, Emergo Group
The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.
According to the CFDA order (link in Chinese), the inspections may cover quality management system and all related research, production and development processes for medical devices registered for sale in China. Inspections are warranted in cases such as:
- Complaints of a device’s quality or safety occur
- Improper or inadequate adverse event reporting
- Serious violations of quality system compliance
- Other quality or safety risks involving a device are suspected
In instances where investigations yield problems or violations, CFDA may undertake disciplinary actions including warning letters, additional investigations, product recalls or revocation of quality system certification.
The legal basis for surprise regulatory inspections of medical device firms was established in 2012 under the Working Procedures for Unannounced Inspection of Medical Device Manufacturers, which was set by the CFDA’s previous iteration, the State Food and Drug Administration.
Emergo will monitor the situation in China for additional details in terms of implementation and enforcement of the surprise CFDA inspection program and its impact on registrants.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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