Full article reprinted from PharmAsia News - October 6, 2008
Find out why within two years Chinese brands of medical devices "will be very noticeable in the world market," says Julio A. Reategui, who directs Asia-Pacific compliance and regulatory affairs for medical imaging firm Medrad.
Full article reprinted from PharmAsia News - October 6, 2008
Within two years Chinese brands of medical devices "will be very noticeable in the world market," says Julio A. Reategui, who directs Asia-Pacific compliance and regulatory affairs for medical imaging firm Medrad.
Chinese manufacturers are harmonizing their standards to come more closely in line with their international competitors, Reategui said in an interview.
In the past Chinese products were kept inside China because Chinese manufacturers could not afford to develop products with two configurations - one for China and one for the international market, he said.
"Now that you are going to have closer standards, the barriers are disappearing for the Chinese manufacturers that want to go outside China," Reategui noted. "There's going to be stronger competition and they are coming up with pretty good products now. The quality of their products is really improving."
Reategui added that Chinese companies offer almost all the same medical devices available in the Western world in China now, with the exception of some specialty devices or leading-edge devices.
"Devices that are considered commodity items, X-ray equipment, vital-signs monitors, all the day-to-day devices, infusion pumps, that are technology that has been around several years now, you can get in China today, and those are the things that you're going to see on the international market," he said.
Complex devices that have IP protection outside the U.S., or that are technologically complex, or that require very high reliability, are "not going to be as successful because people are going to look at them with some reservation," he noted. "But Class I and Class II devices: you can expect massive increase of trade going out from China."
Larger firms such as Mindray Medical and China Medical Technologies are already expanding their international footprint in markets including in vitro diagnostics, imaging and patient monitoring (PharmAsia News, March 12, 2008).
Reategui noted that in most cases Chinese manufacturers still need to forge partnerships with foreign distributors, "but it's no longer the foreign company that gets their product manufactured in China and therefore [dominates] in company sales worldwide. Now it's going to be the Chinese company that makes Chinese products ... with somebody on the outside and then the Chinese products enter the market." This "is going to require a change in the paradigm that we are used to."
Forging Relationships: Be Proactive, But Patient
Companies who wish to develop collaborations in China and have not already started working on this are behind the curve, according to Reategui.
"The Chinese themselves ... are very entrepreneurial," he said. Many of them have been trained in Western universities, and Chinese companies are now using top-of-the-line production facilities, "so that is changing the traditional way of doing business in China.
"It's no longer that they have this local mentality. They, themselves, are becoming global."
But device consultant Chang-Hong Whitney pointed out that while China is making rapid advances, it is still, in many ways, a developing country. "We have to give the Chinese time to grow," she said. Foreign manufacturers' expectations for China to exactly mirror Western regulatory systems "only creates resentment from the Chinese side," she said, and is "asking China for too much and too early."
Chinese firms may give in to global standards, but then "add something else in there to make it uniquely Chinese, and you can't go and say, 'OK, how come you're not exactly like the international one?'" the Whitney Consulting president explained. "The Chinese will say, 'Because we're China. We have to be different.'"
But when they realize it is necessary for their products to be sold on the world market, Whitney said, they will harmonize their regulations.
- Ingrid Mezo
[Editor's note: PharmAsia News will host a webinar Oct. 15 for pharmaceutical and medical device firms entitled "U.S. FDA Inspections in China." For more information, please click here.]
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