China To Conduct Surprise Inspections On Device Manufacturers

By Jof Enriquez,
Follow me on Twitter @jofenriq

Starting Sept. 1, the China Food and Drug Administration (CFDA) will conduct regular surprise inspections on medical device and drug companies as part of a wide-ranging effort to raise the quality of healthcare products for both the local and foreign markets.

China's official government news agency, Xinhua, reports that CFDA will not notify companies of inspections in advance, and that local law enforcement agencies will not provide information about the process or problems identified by investigators during inspections. Any law enforcement personnel caught leaking confidential information will reportedly be subject to discipline or, possibly, criminal prosecution.

"When all the evidence has been collected and the nature of problems determined, local CFDA units will inform the manufacturers of rectification instructions," Xinhua reports. "Surprise checks will also be launched when authorities are contacted by whistle-blowers from the public or become suspicious of certain firms,” said the CFDA.

Surprise inspections could encourage companies operating in China to raise local manufacturing practices to international standards. Focusing on high-quality matching those of imported devices, rather than on pricing alone, would allow China's homegrown device companies to compete with their foreign counterparts over the long-term.

According to Reuters, Miao Wei, the head of China's Ministry of Industry and Information Technology (MIIT), said in a statement last year that China needed to raise the level and quality of its homegrown medical devices, and to create incentives for domestic hospitals to use locally-made products in order to stimulate the local market and mitigate soaring healthcare costs.

However, developing its local medical device sector is predicated on a strong regulatory framework, something China still is building. Although the Chinese government has implemented tougher actions to back its local device sector, there remains much room for improvement.

Christopher Hickey, Ph.D., the U.S. Food and Drug Administration's (FDA) country director for the People’s Republic of China, described in a blog post that China's regulatory system is fraught with "problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others."

These issues notwithstanding, Chinese device exports to other countries — including the United States — have continued to increase. Hickey writes that shipments of FDA-regulated products from China quadrupled between 2007 and 2013. Since the volume likely will rise further in coming years as China's local device sector expands, Hickey cites the need to cooperate more closely with FDA's equivalent agency, the CFDA. Inspections and enforcement are key steps in the process.

"As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts," Hickey states in the blog post.

Hickey adds that the FDA has "trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials. Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum. These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA’s efforts to promote and protect U.S. public health."

As previously noted by Med Device Online, the Chinese medical device market in 2015 is valued at $11 billion, relatively small when compared to the American ($160 billion) and European ($115 billion) markets. However, this is a largely underserved market, and BMI Espicom projects the market to grow 15.7 percent annually between 2013 and 2018.