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Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

Regulatory Updates | Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • China’s National Medical Products Administration (NMPA) has expanded its list of medical devices and IVDs exempt from clinical trial requirements for the second time in 2018.
  • NMPA now exempts more than 1,200 products from clinical trial requirements in China.

China’s National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration, has added more medical device and IVD product types to its list of products exempt from clinical trial requirements in the country.

According to an NMPA notice (link in Chinese), the regulator has added 84 medical device product types as well as 277 IVD product types to its summary clinical exemption list. With these latest additions, NMPA has now exempted 855 medical device types and 393 IVD types from clinical trial requirements in China.

These latest additions mark the second time so far in 2018 that NMPA has expanded its clinical exemption list. Most recently in July, Chinese regulators included several types of moderate- and high-risk devices as well as IVDs to the list. These and related moves easing clinical trial application as well as other medical device regulatory requirements demonstrate NMPA’s ongoing efforts to loosen Chinese market entry restrictions for overseas device and IVD manufacturers.

Additional Chinese medical device and IVD regulatory resources:

  • China NMPA medical device and IVD registration consulting
  • Chia medical device clinical testing requirements assessment
  • Regulatory process chart: China NMPA regulatory approval
  • Whitepaper: China medical device registration requirements

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