New regulations impact China’s medical device sector
2015/6/4??????view:
New regulations in China have had a strong impact on medical device industry and in particular on medical plastics, according to the boss of a medical device contract research organisation.
Jonathan Zhong, managing director of Guangzhou-based Osmunda Medical Device Service Group, told Plastics News that last year the Chinese government had issued 40 new regulations impacting the entire medical device industry.
With its 5 Rectifications Campaign, the government shut down 100 low-end medical device suppliers and revoked 1,000 registration licenses, more than half of which belonged to manufacturers of low-end plastics medical devices.
“This really stepped up the management of medical plastics suppliers,” he said.
At the same time, he added, the government has been strongly pushing for innovation in polymer medical devices, which will encourage growth in the sector. Eight plastics products were approved by the government, he said.
Zhong added that in January, the government came out with a medical device supplier inspection guide to help OEMs better check their suppliers and help them select suppliers who better fit their needs.
“This has led to higher demand for manufacturers using plastics materials,” he said. “I’ve already seen the results of these changes.”
Zhong said that on the whole, the new regulations were good for the medical plastics sector and medical device manufacturers were having to follow much more stringent procedures. “So for high-grade product manufacturers it will increase scrutiny, but for low-risk product manufacturers it will loosen requirements.”
With more than 150,000 medical device manufacturers in China, it is difficult for many to control the quality of their suppliers, because their production capabilities are quite small. The regulations raise the threshold, Zhong said, weeding out some small producers.
Jonathan Zhong, managing director of Guangzhou-based Osmunda Medical Device Service Group, told Plastics News that last year the Chinese government had issued 40 new regulations impacting the entire medical device industry.
With its 5 Rectifications Campaign, the government shut down 100 low-end medical device suppliers and revoked 1,000 registration licenses, more than half of which belonged to manufacturers of low-end plastics medical devices.
“This really stepped up the management of medical plastics suppliers,” he said.
At the same time, he added, the government has been strongly pushing for innovation in polymer medical devices, which will encourage growth in the sector. Eight plastics products were approved by the government, he said.
Zhong added that in January, the government came out with a medical device supplier inspection guide to help OEMs better check their suppliers and help them select suppliers who better fit their needs.
“This has led to higher demand for manufacturers using plastics materials,” he said. “I’ve already seen the results of these changes.”
Zhong said that on the whole, the new regulations were good for the medical plastics sector and medical device manufacturers were having to follow much more stringent procedures. “So for high-grade product manufacturers it will increase scrutiny, but for low-risk product manufacturers it will loosen requirements.”
With more than 150,000 medical device manufacturers in China, it is difficult for many to control the quality of their suppliers, because their production capabilities are quite small. The regulations raise the threshold, Zhong said, weeding out some small producers.
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