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Results:1-10 of 56

China's New Medical Device Regulations Bring Big Changes
  • Ropes & Gray LLP
  • China
  • July 26 2018

The People's Republic of China Ministry of Justice recently published a comprehensive draft amendment outlining the proposed revisions to the current


China’s MOJ Solicits Comments on Amendment to Medical Device Regulations
  • Ropes & Gray LLP
  • China
  • June 29 2018

The PRC Ministry of Justice recently published a comprehensive draft amendment (“Draft Amendment”) outlining the proposed revisions to the current


China FDA Releases Guidance on Acceptance of Foreign Medical Device Study Data
  • Ropes & Gray LLP
  • China
  • January 19 2018

On January 10, 2018, the China Food and Drug Administration (“CFDA”) announced the implementation of the Technical Guidelines Governing Acceptance of


Impact of Value-Based Health Care on the Medical Device Industry: Three Takeaways From the Case for Transformation
  • Ropes & Gray LLP
  • USA
  • September 7 2017

In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or


Regulation on the Supervision and Administration of Medical Devices amended
  • Ropes & Gray LLP
  • USA, China
  • June 28 2017

On May 19 2017 the State Council promulgated amendments to the Regulation on the Supervision and Administration of Medical Devices 2014, which took


CFDA calls for comments on key policy proposals
  • Ropes & Gray LLP
  • China
  • May 31 2017

On May 11 and 12 2017 the China Food and Drug Administration (CFDA) issued four new draft policies for public comment, proposing further reforms to


China Announces Amendments to Regulation on the Supervision and Administration of Medical Devices
  • Ropes & Gray LLP
  • China
  • May 25 2017

On May 19, 2017, China’s State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices


Brave New World: Compliance and the Transition to Value-Based Care
  • Ropes & Gray LLP
  • USA
  • May 22 2017

The U.S. health care system is in the midst of a fundamental shift, away from traditional “fee-for-service” models that reward providers for the


Recommendations for Medical Device Manufacturers
  • Ropes & Gray LLP
  • USA
  • April 27 2017

The U.S. health care system is in the midst of a fundamental shift, away from traditional fee-for-service models that reward providers based upon the


FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity
  • Ropes & Gray LLP
  • USA
  • January 17 2017

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices