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Results: 1-10 of 17

China amends its cornerstone Regulation on Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 7 2014

On March 31, 2014, China's State Council published the amended Administrative Regulation on Medical Devices, which will become effective on June 1

China issues implementation rules for its new pharmaceutical and medical device blacklist system

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 19 2014

On December 27, 2013, China's National Health and Family Planning Commission (NHFPC) published an agency rule to update the "blacklist system" for

China formulates special regulatory pathway for innovative medical device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 11 2014

China Formulates Special Regulatory Pathway for Innovative Medical Device Products On February 7, 2014, the China Food and Drug Administration (CFDA

China promulgates draft Good Supply Practices for Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 20 2014

The China Food and Drug Administration ("CFDA") published a draft of its first nationwide Good Supply Practice for Medical Devices (the draft "GSP"

Global Pricing Newsletter: volume two

  • Sidley Austin LLP
  • -
  • China, Global, United Kingdom, USA
  • -
  • February 27 2013

Pharmaceutical and biologic manufacturers operate in an increasingly global economy where legal developments in one market may have cascading impacts

China encourages pharmaceutical companies to timely pursue new GMP certification

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

SFDA finalizes its rules on packaging and labeling of imported medical devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • October 9 2012

On September 24, 2012, China’s State Food and Drug Administration (SFDA) issued the final Notice on Further Regulating Labeling and Packaging of Medical Devices Manufactured Overseas (the “Notice”), which will become effective on April 1, 2013

New Chinese medical device GCP unveiled for public comments

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

SFDA to enforce blacklist system for unsafe drug and device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • August 21 2012

Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well

Updates on international pricing issues for pharmaceutical and biologic products

  • Sidley Austin LLP
  • -
  • China, European Union, France, Germany, United Kingdom, USA
  • -
  • May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies