New Chinese Regulations for Medical Device Manufacturing

A recently published alert by the law firm Ropes and Gray provides an excellent summary of new changes in Chinese regulations for medical device manufacturing. In December 2014, China’s Food and Drug Administration (CFDA) revised the existing provisional Good Manufacturing Practices for medical devices (New GMP), and issued the country’s first Good Supply Practices for medical devices (GSP). The New GMP rules will become effective on March 1, 2015, and the GSP rules came into effect December 12, 2014.

These rules serve as minimum standards for the quality management systems of device manufacturing and distributionregulations in China. They form an important part of China’s new device regulatory regime that was substantially transformed since the promulgation of the Regulation for the Supervision and Administration of Medical Devices (also known as State Council Order No. 650) on June 1, 2014.

The new rules adopt three guiding principles:

  • End-to-end risk management
  • Traceability
  • Detailed requirements for workshops and equipment

      The Regulatory Affairs Professionals Society notes that the Chinese press outlet Xinhua reported that the changes could force medical device manufacturers to take on more staff. Plants must have staff monitoring the quality of the manufacturing operation, as well as an employee who cooperates with institutions tasked with investigating malpractice. If quality problems are detected, manufacturers should halt sales immediately.

The updated regulation on good distribution practices for medical devices that came into force in December mandates the creation of quality management systems at distributors. CFDA will also assess quality control measures covering the purchase, acceptance, storage, sales, transportation, and after-sales service of medical devices

While these changes are significant for foreign-based medical device manufacturers operating in China, they also should be seen as an effort to strengthen the domestic sector, stewarded by China’s National Health and Planning Commission. According to Forbes, the Chinese government is committed to pursuing policies explicitly designed to favor domestic manufacturers over foreign manufacturers, something that will impact the global med-tech sector.

Stay tuned.

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