(Yicai Global) Sept. 7 -- The China Food and Drug Administration has approved a series of China-made pacemakers that will break a long-existing monopoly of imported products and could benefit many Chinese patients.

The RegaTM Heart implanted pacemaker, made by Chuangling Cardiac Rhythm Management Medical Equipment Shanghai Co., a joint venture under MicroPort Scientific Corp. [HKG:0853], has become the first Chinese pacemaker to be approved by the CFDA and meet international quality standards.

Pacemakers are currently the only effective way to treat bradycardia, or a slow heart rate, and can reduce the mortality rate and improve patients' quality of life.

China has around a million bradycardia sufferers and the figure increases about 300,000 to 400,000 a year. However, before mastering the technology behind pacemakers, the country relied on imported products and foreign-invested brands. The high price of imported products means only around 80,000 patients a year can receive the treatment.

"Chuangling Heart's pacemakers are automated, physiological, small and have a long service life," Wang Li, the firm's chief executive officer, told Yicai Global. "They are only 8 millimeters cubed in size and are the smallest on the market. They can last up to 12 years.

"After release, they will satisfy a variety of patients' needs and cost 20 to 30 percent less than imported products of a similar standard."