CFDA updated Medical Device GMP
In September 2015, the China Food and Drug Administration (CFDA) issued their updated Medical Device GMP. GMP stands for “Good Manufacturing Practices” and is a quality assurance system on the use of Medical Devices.
This quality system includes requirements related to the methods used in, and around facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices intended for human use. Therefore the quality can be guaranteed only when the production process from beginning until end is entirely carried out at a precise prescribed and controlled manner. This way of production is called Good Manufacturing Practises and gives manufacturers of medical devices greater flexibility in achieving quality requirements.
From February 1, 2016 this update will go into effect and as a consequence bring China-based sites closer into alignment with global standards. It is very important that the manufacturing sites are in compliance with the regulations to ensure no disruption to the supply chain.
For more information about CFDA approval or any other inquiries about CFDA or GMP contact our experts.