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.

The Quality System

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 has gone 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.

NMPA

The National Medical Products Administration (NMPA) replaced the China Food and Drug Administration (CFDA) as the regulatory authority overseeing medical devices and pharmaceuticals in China in 2018. This restructuring was part of a broader effort to improve the regulation and supervision of the pharmaceutical and medical device industries in China. The NMPA was established to streamline and enhance regulatory oversight, the NMPA China guidelines ensure the safety and quality of medical products, and align with international standards and best practices.

How can we help?

If you have any questions related to Medical Device GMP, implementing a QMS, the export of medical devices and the medical devices regulations in China, please do not hesitate to contact us.

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