China Blog Posts

China FDA Changing Medical Device, IVD Submission Requirements

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) plans to ease certain requirements for registration renewals and clinical trial application processes.
  • CFDA also intends to launch a more robust electronic registration submission system for market applicants.
  • Implementation of these plans would result in less onerous Chinese market entry pathways for foreign device manufacturers.
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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.
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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  • The China Food and Drug Administration has issued draft guidance on regulatory requirements for 3D-printed medical devices.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.
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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.
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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.
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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.
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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
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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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China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements

EMERGO SUMMARY OF KEY POINTS:

  • CFDA has proposed adding more Class II and III medical devices and IVDs to its clinical trial exemption list.
  • The regulator has already exempted more than 300 Class II and about 100 Class III devices from clinical trial requirements.
  • CFDA registrants qualifying for these exemptions may submit clinical data obtained outside China for market application purposes.
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New CFDA Medical Device Classification Catalog May Require New Registrations in China

EMERGO SUMMARY OF KEY POINTS:

  • A new China FDA classification catalog may require new registrations for some medical device market applicants.
  • Changes in classification requirements in the new catalog may result in up-classification (and re-registration) of some Class I medical devices in China.
  • The new classification catalog will be implemented on August 1, 2018.
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