Lin Xianyong, Director of Medical Device Safety Supervision Div., SFDA Shanghai, offered a candid appraisal of the pitfalls of the current state of China’s medical device regulatory process during the recent MEDTEC China exhibition and conference. He summarized the flaws of the system as follows.
There is too much ambiguity regarding the responsible party following product launch. Current regulations are centered around governmental oversight, since the product permit license, registration certificate and business licenses are approved by government offices. This gives companies the false impression that once medical devices have been launched in the marketplace, the government, and not the manufacturer, should be held responsible for any legal liability.
Substantive supervision is required. All those permits and registration certificates have no in-depth meaning, said Lin Xianyong, unless the content is objective and real. Effective supervision should not be merely about issuing certificates, but should take into account efficiency and administrative costs. Dynamic oversight must be practiced, he added, and device manufacturers need to self-supervise. They can make use of social resources to heighten supervisory effectiveness by introducing third-party participation in the process.
Boost credibility. Some companies are not overly concerned about adverse events and recalls after the products have been introduced in the marketplace, thus losing credibility. Adverse events may be caused by inadequate risk management on the part of the manufacturers, and they do not help their case by avoiding responsibility, which is often their first impulse. That’s mainly because the company is not perceived to be liable, as noted above.
Misunderstanding quality. Quality systems are the foundation for ensuring product quality. Companies in the medical device space should establish and implement quality systems. The status quo, however, is for companies to focus on receiving certification rather than implementing it on a consistent ongoing basis. They lack a strong sense of quality management.
Going forward. The flaws of the current medical device system are obvious and should be corrected by improving the regulatory framework and setting up an effective supervisory system. Each party’s responsibility, rights and obligations should be clarified. Manufacturers should take responsibility for their products, said Lin Xianyong.
The approval process has too many steps and takes too long, and there are no public approval standards and procedures. There is no clearly defined evaluation and approval responsibility or well-established supervisory mechanism. The emphasis is on evaluation rather than supervision, on rights rather than responsibilities. Consensus has been reached among Chinese medical device manufacturers regarding these current flaws as well as on a prospective direction for the regulatory system.
MEDTEC China, produced by UBM Canon, was held 26 and 27 September 2012 in Shanghai. The event returns to Shanghai in 2013 on 25 and 26 September.
—Helen Zhang, Associate Editor, China Medical Device Manufacturer