CFDA

China FDA Adds to List of Medical Devices, IVDs Exempt from Clinical Trials

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have added additional Class II and III medical devices as well as some Class III IVD devices to their list of products exempted from clinical trial requirements.
  • Devices in the latest batch of exemptions include lancets, anesthesia needles and incubators.

China FDA Eases Country-of-Origin Requirements for Hong Kong-based Medical Device Registrants

The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements.

Changes to Chinese Medical Device Regulations would Benefit Foreign Manufacturers

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have drafted changes to Order No. 650 covering various medical device regulatory requirements.
  • Proposed changes would affect product test reports, clinical evaluation report (CER) requirements, importing of innovative devices, and more.
  • The Chinese government has not yet announced firm implementation timeframes for these changes.

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.

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.

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