China to Cut Regulatory Red Tape for Medtech Firms

Nancy Crotti

December 19, 2014

2 Min Read
China to Cut Regulatory Red Tape for Medtech Firms

China has agreed to cut some of the bureaucracy that delays sales of medical devices and medicines made in the United States, the U.S. commerce secretary announced.

Following bilateral trade talks between the two nations, Commerce Secretary Penny Pritzker told reporters that the Chinese government had agreed to reduce regulations blocking use of innovative medical devices and pharmaceuticals, according to a report by Reuters.

An assistant minister of commerce, Zhang Xiangchen, told reporters China would try to make the review and approval process for U.S. products in the pharmaceutical and medical industries more efficient, and address a backlog within two to three years, according to a report by the Associated Press.

U.S. and Chinese officials made the announcements following the three-day meeting in Chicago. U.S. firms have complained that the Chinese approval process is burdensome, the Reuters report said.    

"We will also reduce as much as possible needless clinical trials," Zhang said through an interpreter, according to the AP report.

Pritzker predicted that Chinese promises regarding  medtech and pharmaceuticals "should lead to (an) increase in U.S. exports and U.S. jobs in these two important sectors," the AP story said.

The talks also yielded a pledge from Chinese officials to apply antitrust regulations equally among domestic and foreign companies. China agreed to publish the results of antimonopoly legal proceedings and allow U.S. firms to consult with legal counsel, Pritzker said, according to the Reuters report. Businesses have complained that China's laws are difficult to decipher and single out foreign companies.

These announcements signal a softening of Chinese regulations announced as recently as a year ago. In August 2013, the Chinese Ministry of Health (MOH) in Beijing announced the start of a 90-month usage review of high-value consumable medical devices. Large-scale medical devices would be placed under additional scrutiny, the ministry said.

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, the ministry said at the time. Chinese officials said they hoped the investigation would improve hospital management of medical devices.

In 2013, the pharmaceutical industry was hit with both administrative and criminal enforcement actions in China.

Nancy Crotti is a contributor to Qmed and MPMN.

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About the Author(s)

Nancy Crotti

Nancy Crotti is a frequent contributor to MD+DI. Reach her at [email protected].

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