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Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development

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EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators plan to develop new medical device standards over a two-year period.
  • The standards will cover risk management, quality and clinical trials, and align with international standards, according to CFDA.
  • CFDA will also hire up to 200 additional staff to support standards development.

China CFDA medical device standards development 2018 to 2020The China Food and Drug Administration (CFDA) has announced a two-year plan to develop medical device standards covering risk management, quality control and clinical trials.

The new CFDA notice (link in Chinese) states that over the course of 2018 through 2020, the regulator will focus on developing standards for active and non-active medical devices as well as IVD products, and align its work with appropriate international standards.

Which types of devices will China FDA standards cover?

In the active medical device category, CFDA plans to develop standards specifically for medical robots, active implantable products, medical software, PET-MRI device as well as radiation therapy products.

Non-active devices for which CFDA will develop standards include novel surgical devices, dressing materials, tissue engineering technologies, nanotechnology and absorbable medical materials.

IVD-related standards CFDA will pursue include those for molecular and genetic diagnostics, point-of-care testing tools and mass spectrometry tools.

To support its new standards development initiative, CFDA plans to hire up to 200 additional employees by 2020.

Potential impact for Chinese medical device market registrants

Establishing standards to which CFDA applicants can map their compliance efforts for risk management and quality control should provide a more transparent path to market for medical device and IVD manufacturers interested in China.

Teemo Chang is Technical Consultant at UL Life & Health Sciences in Guangzhou, China.

Related CFDA regulatory information from Emergo:

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