China Takes Its First Step Toward Regulatory Reform

By Joni Bouley

China’s up-and-coming presence in the medical device industry is more evident than ever with many top device companies bolstering their presence in China’s major cities. Upon returning from the MedTec China show a couple of weeks ago, our team had much to share, among which was a discussion around the reception at the show of our Quality Management System and assumption that because we were U.S. based and have a full QMS in place, our services “must be very expensive.” Recently the lack of quality regulation being displayed in China’s medical device manufacturers has raised some eyebrows, including our own. MedTechInsider.com released an article on China’s regulatory processes (or lack thereof) that quotes a candid appraisal by Lin Xianyong, Director of Medical Device Safety Supervision Division, SFDA Shanghai.

View from the China Medical Equipment Show in Shenzhen in April,
where we first observed a trend of ‘quantity over quality.’

The main concern with China’s regulatory standards is that, simply put, they don’t fully exist. Medical device manufacturers prioritize quantity over quality, pushing products out to market and then assuming the government will take over from there. The culture behind China’s manufacturing industry in general does not promote small-scale quality assurance, though it is for this reason that the country has become the world’s go-to mass producer. Manufacturers must apply for approval from the government for product permits, registration certificates and business licenses. Because the government gives these authorities, Xianyong says, “companies [are under] 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.”

But recalls and mishaps with products in the market are not the responsibility of the Chinese government.

Quality systems should be implemented as part of the manufacturers’ processes, but instead companies focus on receiving the government certification rather than implementing a system that will function consistently on an ongoing basis. As Xianyong puts it, “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.” Zhang, the writer of the article, clarifies that there are no public approval standards and procedures, and supervision is not a priority. The government and manufacturers are passing a hot potato that neither feels responsible for.

Xianyong concludes by stating an obvious, but seemingly overlooked, conclusion: each party needs to define its respective roles. “Manufacturers should take responsibility for their products,” he says.

China is an unstoppable force on numerous levels, with mass-production being one of its top strengths. They can efficiently and effectively bring large quantities of a product to market…but can they ensure quality and follow through when a product fails? The good news is that manufacturers have recently reached a consensus and agreed upon the urgency of these issues. The Chinese medical device industry has acknowledged these flaws and is mapping out a prospective regulatory overhaul.

The acknowledgement of individual parties’ accountability is a major step toward genuine systematic improvement, and it is encouraging to see that China has finally taken its first stride toward effective device manufacturing regulations.

Read the full article.