Chinese Medical Device Market Faces Regulatory Crackdown
August 16, 2013
On Thursday, the Chinese Ministry of Health (MOH) in Beijing announced the start of a 90-month usage review of high-value consumable medical devices. In addition, large-scale medical devices would be placed under additional scrutiny.
In the announcement, the Ministry of Health in Beijing stated that previous hospital inspections had found significant issues with the overuse and misuse of medical devices. In many cases, improper usage was done to increase hospitals' earnings. With the investigation, officials at the MOH hope to improve hospital management of medical devices.
To ensure follow-up, the government regulatory agency will create a database to track the model and price of medical devices that patients use. This will require hospitals to improve medical device acquisition management systems. In addition, the MOH will conduct inspections of hospitals to ensure proper management and purchase procedures for consumable medical devices.
Over the past 60 days, there have been several significant regulatory actions in China against the life sciences industry. In particular, the pharmaceutical industry has been hit with both administrative and criminal enforcement actions. The infant formula segment was also hit with a pricing investigation by the National Development and Reform Commission.
Prior to these latest enforcement actions, authorities in China issues a series of administrative regulations. These included new guidance on anti-bribery controls and a new conduct code for HCPs.
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