February 25, 2020

February 24, 2020

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China’s Legislative Affairs Office of the State Council Extends Comment Period for Proposed Rules Implementing the Revised Medical Device Regulation

Recently, the China Food and Drug Administration (CFDA) extended the comment period for five key rules implementing China’s revised medical device regulatory system.  Device companies and other stakeholders now may comment on these rules until May 31, 2014.

As background, on March 7, 2014, China’s State Council promulgated substantial amendments to the Medical Device Supervision and Administration Regulation (Medical Device Regulation, or MDR), which is the highest level regulation on medical device in the country.  The MDR, effective June 1, 2014, addresses issues such as research and development, approval and registration, registration supplement and renewal, manufacturing, importation, distribution, device use in medical institutions, advertising and promotion, postmarket surveillance, and penalties.  Shortly after the State Council promulgated the amended MDR, on March 31, 2014, the CFDA published five proposed implementing rules for public comment on registration, manufacturing, distribution, and the use of medical devices:

  • The Medical Device Registration and Filing Measures;

  • The Registration and Filing Measures for In Vitro Diagnostics;

  • The Medical Device Distribution Supervision Measures;

  • The Medical Device Manufacturing Supervision Measures; and

  • The Administrative Provisions on Package Inserts, Labeling, and Packaging.

For more information about these proposed rules, please see our client alert.

On April 30, 2014, after the expiration of the 30-day comment period for CFDA’s five proposed rules, the five proposed rules were re-issued on the CFDA website and on the State Council’s Legislative Affairs Office website with an additional 30-day comment period that will end on May 31, 2014.  This extension—an unusual development in China—offers stakeholders another opportunity to review the five CFDA proposed rules.  For example, stakeholders will benefit from the extended comment period so they can consider the proposed rule on registration and filing procedures and possibly submit comments to support or reject provisions that are designed to decrease or increase regulatory burden on stakeholders.

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About this Author

Mingham Ji, regulatory and public policy lawyer, Covington

Mingham Ji advises pharmaceutical, biotechnology, and medical device clients on a broad range of regulatory, legislative, and compliance issues before FDA and other regulatory agencies. Ms. Ji has particular experience counseling clients on strategic considerations around engagement with and advocacy before FDA, including through formal dispute resolution proceedings, comments to public dockets, and other submissions to the agency. Her work in this area has spanned both drug development and post-approval issues, including pediatric testing requirements and pediatric...