With regard to review and approval of finance lease of large-scale medical device, pilot medical device enterprises of finance lease in Nansha Free Trade Zone are not required to apply for a Medical Device Business License. They only need to operate directly according to the business scope recorded in the business license. After the reform, if pilot enterprises in the demonstration area have made qualified promises, they can operate directly according to the business scope recorded in the business license, and do not need to apply for a business license. Medical equipment supplier and lessee (medical institution) shall take the responsibility of incoming inspection, sales records, transportation, storage and management of medical devices by signing a third party responsibility agreement of medical device quality and safety management. The medical equipment supplier shall come with business qualification.
In February of this year, Management Committee of Xiamen Free Trade Zone, Market Supervision Commission of Xiamen Municipality and Xiamen City Health Planning Commission jointly issued the "Several Opinions on the Supervision and Reform of Finance Lease of Large Medical Devices in Xiamen Pilot Free Trade Zone, Fujian Province" (hereinafter referred to as the Opinions). According to reports, the newly issued Opinions, having been formulated according to the industrial characteristics of finance lease, will provide more convenience to enterprises in need of finance lease.
Large medical equipment is different from the pharmaceutical field and its market capacity is relatively small. It would be difficult to overcome barriers between research and development, professional academic promotion and after-sales service. Medical institutions cannot meet their huge demand for high-value consumables, medical equipment, and diagnostic reagents only with their funds. In addition, the scale of finance lease is still very small. By the end of 2014, finance lease of medical equipment in China accounted for less than 10% of the total sales of medical equipment in the same year. However, backed by professional leasing companies such as manufacturers’ system or independent system, the proportion of US medical equipment upgraded by finance lease reached 80%. Therefore, there will be a bright prospect for finance lease of medical devices in China. As revealed by public data, in 2016, the market size of China's medical equipment reached CNY 248.942 billion, a surge of 16.18% over the same period of the previous year. In the same year, the total amount of finance lease of medical devices reached 85.8 billion, accounting for 34.5% of the total sales.
The loosening policies will allow finance lease to play a increasingly bigger role in the medical equipment industry.
