Chang-Hong Whitney07.06.08
Looking back at the past year of quality initiatives, it seems prudent to provide an update on continuing programs in China.
In the November/December 2006 issue of Medical Product Outsourcing, this column reported that random quality inspections of products on the market were being conducted by the SFDA. This program is still in effect and continues to generate reports on various products.
In an effort to improve product quality and help amend the reputation of Chinese products in international markets, China’s State Council, the top economic management agency, issued a document, titled Special Requirements to improve Safety and Supervision of Food and Other Products, on July 26. This document is aimed at strengthening safety regulations for food, drugs and medical devices. The notification, although lacking specific details, signals the central government’s determination to correct past practices and install internationally acceptable business practices across the food and drug, as well as medical device, industries.
Besides the national programs, regional food and drug administration agencies have launched various programs to inspect medical device manufacturers and distributions. Registration documents of Class II and Class III products were reviewed for accuracy and truthfulness.
Other state agencies are stepping up to manage product quality as well. The Administration of Quality Supervision Inspection and Quarantine issued a new regulation in June about inspection of imported medical products. As of press time, the detailed implementation guidelines were expected to be released in October, with the official implementation set to begin Dec. 1.
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It is clear to everyone that China needs to work on its product quality for the benefits of its own citizens and international customers. Watching the developments and activities by the SFDA and other agencies, the direction is set toward better control and quality. The slowdown in market growth in the coming years also may provide a much-needed breathing time for companies to focus and realign their priorities.
Let’s hope that, in the future, none of our colleagues and companies will have to deal with the situation facing Mattel right now.