China Launches Campaign to Crack Down on Medical Device Quality

On March 24, 2014, the China Food and Drug Administration (CFDA) announced a 5 month national campaign to reinforce medical device product standards. The campaign will focus on the manufacture, sale and usage of Class 2 and Class 3 devices. Growing at double digits, the Chinese medical device market was worth approximately $13 billion in 2013. However, the fast expansion of the device market has meant more medical device quality issues.

The CFDA’s campaign will be spearheaded by the Department of Medical Device Supervision, newly created in the CFDA’s 2013 reorganization. There are 5 key areas of quality problems that the CFDA will focus on during the national campaign:

  1. Usage of unregistered products at hospitals
  2. Illegal advertising of devices
  3. Distribution of unlicensed devices and violations in device distribution
  4. Product manufacturing deficiencies
  5. Product registration fraud

The CFDA has called on provincial FDAs to impose the maximum punishment on any company that is found to be violating or not complying with the law. Punishment can include cessation of sales, product recall and cancelation of operating licenses.

As of April 15, the CFDA announced that local authorities had conducted unannounced visits to more than 100 businesses, such as pharmacies and medical device shops. These visits resulted in fines of up to several thousand dollars, arrests of 10-20 people in some cases, and confiscations of equipment — like ultrasound diagnostic apparatus or x-ray imaging systems — valued at more than $100 million in one case. The CFDA has also published a list of websites with illegal advertisements and/or counterfeit devices.

In pharmaceutical news, the CFDA and the Ministry of Public Security (MPS) announced on March 28 that a drug investigation bureau would be set up by the MPS to better police regulatory compliance and drug supervision. CFDA statistics show that there were 43,000 cases related to food and drug safety in 2013, many involving fake drugs.