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 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:
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.
CFDA: What's new