China FDA to Issue Hundreds of Revised Device Standards Over Next Two Years

February 16, 2018

China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics up to international standards.

The standards will cover technical requirements for development, risk management, quality control and clinical trials.

The revisions are part of ongoing reforms including more stringent medical device standards, improved quality system management and oversight as well as improved inspections. CFDA also wants to encourage innovation within the country, and the agency said it will identify priority areas for innovative device development to meet unmet needs.

The policies are aimed at strengthening China’s domestic device manufacturers, according to BMI Research.

“A growing number of hospital procurement initiatives giving priority to local products and government support for domestic innovation will enhance the competitiveness of Chinese medical devices, further increasing pricing pressures.

The drive to reduce dependence on imported products is gaining momentum under the 13th Five-Year Plan (2016 -2020),” the research group said, in a Feb. 13 report.

BMI noted that, in 2017, several Chinese provinces launched initiatives to boost uptake of domestic products. For example, Anhui province published an action plan stipulating that government-funded projects must purchase domestically produced medical devices.

In Guangdong province, the municipal government is giving priority to domestically produced equipment, as part of its public hospital reform program. The province has also set quotas for public hospital purchasing of domestically produced large scale medical equipment.

Similar initiatives are taking place in Liaoning province, Shangdong province, Sichuan, and Zhejiang.

The BMI report pointed to government support for device innovation under the 13th Five-Year Plan as another driver to increase the competitiveness of Chinese medical devices. “Local companies are starting to move into higher-end products to challenge the dominance of multinationals,” the report said.

For example, EziSurg Medical, a Chinese developer of innovative endoscopic surgery products, whose easyEndo surgical stapler is already competing with Johnson & Johnson’s stapling devices.

As more Chinese devicemakers enter the premium sector of the market, prices will be driven down, BMI said.

CFDA said it will continue to deepen international exchanges and cooperation in medical device standards to encourage its domestic sector to become more competitive.

The agency is also committing more staff resources to support a sustained and stable infrastructure. By 2020, the number of staff in the medical device standard management center will reach 70, and there will be an additional 200 full-time staffers for positions in technical committees and standard management.

China updated its good manufacturing practices in 2014, and the GMPs have been gradually phased in over the last four years. All device manufacturers were expected to be fully compliant with the GMP standards effective on Jan. 1, 2018.

Companies making sterile devices, particularly implantable devices, are being closely watched in China, and quite a few multinational devicemakers have had their overseas plants inspected.