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News about GMP/cGMP

2017-02-28

China Food and Drug Administration: What's new?

This news summarizes the latest regulatory changes for medical devices in China and the newly issued five year-plan of the CFDA (China Food and Drug Administration).

 

China issues five year-plan on food and drug safety

The CFDA (China Food and Drug Administration) has published an exceptionally detailed report on the five-year plan (2016 – 2020) on food and drug safety issued by the Chinese State Council on February 21.

In the area of drug safety it is outlined that China will set stricter standards of medical equipment and that by 2020 the quality of drugs should be further improved. Additionally, the level of supervision will be enhanced. These actions aim at catching up with international levels of quality. The plan requires

  • To finalize a quality consistency evaluation for 289 generic drugs
  • The revision of 3050 national drug standards and 500 medical equipment standards
  • To reach a 100 % rate for updates of periodic drug safety reports
  • A rate of over 0.04 % license holdings for pharmaceutical practitioners.

To better enhance the regulation of drug standards, the government will step up efforts on the revision of pharmaceutical administration law. In addition, the pharmaceutical industry should establish an online approval system.

 

Release of “Medical devices – Quality Management Systems – Requirements for Regulatory Purposes (ISO 13485, 2016).

With this document the CFDA aims at:

  • emphasizing the importance and necessity of implementing regulatory requirements
  • improving the compatibility of regulations and the standard
  • defining that the quality management system standard is applicable to medical device organizations at all stages of the full life cycle industrial chain
  • further guaranteeing the safety and effectiveness of medical devices at all stages of the full life cycle
  • intensifying the new requirements based on risk analysis and risk management
  • advancing new requirements to medical device supply chain and procurement and
  • adding new requirements on the post-market surveillance and improvement of medical devices.

The new ISO 13485 will come into force as of May 1, 2017 and is available in Chinese language.

 

Newly Revised Provisions for Medical Device Recall

The CFDA adopted the revised regulation on the supervision of medical equipment to enhance its safety and effectiveness. The document presents new requirements to the recall of medical devices. The provisions were formulated by the CFDA (Order No. 29).

It will be effective as of May 1, 2017. The document is available in Chinese, only.

Source:

CFDA: What's new

 

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