Asian regulatory update: New industry standards for medical devices in China

January 16, 2011 by Ames Gross

New industry standards for medical devices in China

On Dec. 27, 2010, China’s State Food & Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be regulated beginning June 1, 2012.

Several of the mandatory industry standards are replacing other standards. For example, YY 0054-2010 for hemodialysis equipment will be replacing YY 0054-2003, and YY 0333-2010covering soft tissue dilation devices will replace YY 0333-2002. However, many others are new, such as YY 0804-2010 for medical fluid metastatis.

The recommended industry standards cover sterile medical equipment packaging testing methods, dental root canal devices, orthopedic transplant devices, and more.

The full list of new industry standards in China can be found through this link. (Chinese only).

Indian Ministry of Health drafts notification regarding CTD preparation

India will soon be adopting a Common Technical Document (CTD) for the import, manufacture and marketing approval of new drugs. India’s Union Ministry of Health has produced a draft notification for the preparation of the CTD. The new format will be implemented to create greater ease of use, to prevent omission of important data or analyses, and to improve speed of review. Using the CTD is expected to reduce the time and resources required to compile global applications for registration by a significant amount. Until now, applicants have used many different formats for the filing of their application materials, making the review process difficult and time consuming.

In addition to raising the Indian standard of quality, the CTD will create structure across the entire application filing process and prevent approval delays.

Japan, the European Union, the United States and others have already adopted a CTD format. Though India has already used such a system for biological products since 2009, this will be the first time the CTD will be used in India for pharmaceutical products.

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