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China introduces new legislation regarding medical devices

April 15, 2014
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China will implement much stricter oversight on the medical device market in June.

Reuters reports that after multiple companies were penalized for malpractice by U.S authorities, greater scrutiny of medical devices manufactured in China will be coming in June. Officials in the Chinese government plan to crack down on the industry with new hefty fines and regulations in order to combat any corruption, and these new regulations will necessitate greater scrutiny of the clinical trial process in the country, potentially leading to greater use of medical imaging to verify device safety and efficacy.

In the past, U.S authorities have fined Biomet Inc. and AGA Medical Corp. millions of dollars for malpractice in China, while a similar case with Siemens AG was dismissed last year. The increased focus on product safety has analysts predicting an industry shake-out, eliminating the companies who can not afford to refocus on research and development and quality control.

The medical device market in China has the potential to double to $50 billion by 2020, the Reuters article projects. “China’s health care reform has generated demand for more and better health care, with opportunities for private and overseas investment,” said Huang Yanzhong, senior fellow on global health at the U.S. think tank Council on Foreign Relations.

According to the National Law Review, the new legislation introduces a number of policies directed at optimizing and streamlining the review and approval process for marketing medical devices. In the past, registration certificates were required to be obtained from the China Food and Drug Administration (CFDA) but Class I medical devices will soon be exempt from this requirement. 

Clinical trials can also be exempted for medical devices falling within Class II and Class III in certain circumstances where the safety and effectiveness of the products can be demonstrated by other measures such as non-clinical evaluation or data from clinical trials of similar types of medical devices.

At Medical Metrics, Inc, we specialize in providing imagining for clinical trials of Class III medical devices and surgical procedures. MMI believes in providing strict process monitoring and routine inspections to ensure high-quality data in the clinical trial stage, and we are capable of supporting global clinical trials throughout Asia. Our services include imaging protocol development, medical image management, independent review, and scientific consulting, and we are committed to the highest standard of quality and reliability. 

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