China FDA takes closer look at medical devices

The China Food and Drug Administration said on Monday it has launched a five-month national campaign to shore up product standards in the medical devices industry.

The industry has been developing rapidly in recent years and reached more than 400 billion yuan ($64.9 billion) in sales last year, said Yan Jiangying, director of the administration's general office.

The campaign will inspect manufacturers across a range of medical devices, from large instruments such as computed tomography scans to small tools such as syringes and patches, she said.

The administration said the discovery of devices that have threatened people's health in recent years was the biggest reason for the inspection campaign.

"We found in inspections that some makers of disposable urinary catheters didn't fix their sterilizers in time, their workers were not adequately trained and their products did not meet sterilization standards. Their products increased the risk of infection in users," said Tong Min, director of the administration's medical instrument inspection department.

"In another example, some companies selling in vitro diagnostic reagents only turned on their refrigerators that stored products during inspections in order to save on electricity, which jeopardized the effectiveness of their products," he added.

The administration also revealed that companies have been falsely advertising their medical devices. Some companies, it said, claimed their patches cured hypertension and diabetes.

"No medical instrument can cure diabetes or hypertension. But we often see this (misleading message) in promotions, and it misleads a lot of elderly people," said Yan, the office department director.

The administration said it will impose the "harshest" punishments allowed under current regulations during the campaign and will work with public security authorities on large and complicated criminal cases involving medical devices, said Mao Zhenbin, director of the administration's inspection bureau.

Food and drug authorities in provinces around the country are also being asked to investigate manufacturers of category two and category three medical devices - categories are used to detail the risks associated with the device, with category three being the highest - and provide authentic reports of clinical trials within their applications for permission to manufacture them on a large scale.

Under the Regulations on Medical Instrument Management, issued by the State Council 2000, medical instruments in categories two and three should first pass clinical trials before they can be mass-produced.

Chen Hongyan, secretary-general of the medical instrument branch under the China Medical Pharmaceutical Material Association, said devices that fail to meet standards are more likely to go to unregulated hospitals, clinics or pharmacies.

"We welcome the campaign because it will help clean the industry up and improve its reputation," she said.

But she added that the five-month campaign acts more like a "fire extinguisher".

She said the revision of the Regulations on Medical Instrument Management, expected soon by the State Council, contains more detailed and feasible rules to root out violations.

"The revision has detailed the rules that will be applied across the whole process, including research and development, registration, production, distribution and usage so that there will be fewer loopholes that violators can take advantage of," she said.

wangqingyun@chinadaily.com.cn