CFDA

China FDA Reorganization: Impact for medical device registrants

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) is being reorganized into the China Drug Administration (CDA).
  • A new State Administration for Market Supervision take over management of CDA from the Chinese State Council.
  • Emergo consultants are still determining whether and how the Chinese regulatory reorganization will affect medical device registrants.

Emergo Survey: Tempered Growth Expectations for Medical Device Markets in 2018

Medical device manufacturers’ growth expectations for markets worldwide have decreased for 2018 compared to previous years due to various regulatory and economic factors, a recent survey shows.

New Guidance from China FDA on 3D Printed Medical Device Registration Rules

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration has issued draft guidance on regulatory requirements for 3D-printed medical devices.
  • The guidance proposes specific requirements for validation and related testing for additive manufacturing products submitted for CFDA approval.
  • A final version of the CFDA guidance will be published once stakeholder comments have been received and compiled.

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

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 FDA Two-track Medical Device Testing Policy May be Coming

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) may soon launch a two-track in-country testing pathway for medical devices.
  • A possible commission testing option would cost registrants a fee but allow a potentially faster testing process.
  • No official CFDA rollout of the new testing policy has occurred yet.

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

EMERGO SUMMARY OF KEY POINTS:

  • Chinese medical device market regulators at the CFDA have published new and updated regulations covering clinical trial requirements, mobile medical technologies and device testing issues.
  • The updates include technical guidance on clinical trial designs and mobile medical devices, as well as a notice on funding for local-level device testing centers.

In Brief: New China FDA Guidance on Medical Device Registration Grouping

EMERGO SUMMARY OF KEY POINTS:

  • Final guidance from China Food and Drug Administration (CFDA) on medical device registration grouping criteria
  • First CFDA update on registration grouping guidance since March 2015

More Details on Changes to China FDA Medical Device Clinical Requirements

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) has published new technical guidance on accepting medical device clinical data from sources outside China.
  • Foreign clinical data used in CFDA registration applications must meet China Good Clinical Practice requirements.
  • Chinese market registrants should notify CFDA before submitting applications that they intend to use foreign clinical data in their applications.

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