On April 11, 2018, eight ministries and commissions including the National Development and Reform Commission jointly issued the Opinions on Promoting Pilot Application of the First Set of Major Technical Equipment (FGCY [2018] No. 558). This is an important document that will greatly facilitate the homemade innovative medical devices access into governments’ bidding and public hospitals.
1. National policies have been upgraded for supporting the first set of equipment.
A number of policies have been promulgated and great efforts have been made in order to promote innovation and development of made-in-China equipment, which are reflected in the establishment of dedicated technical and R&D projects, special review and approval of medical devices, and priority approval of medical devices in the field of medical devices. However, the homemade innovative equipment would not necessarily be widely applied following their R&D and appearance on the market despite their lower prices compared with imported counterparts. As they have not been put into use before, users have great concerns over using the first set of homemade equipment. In addition, some existing policies and mechanisms restrict the promotion and application of the first homemade equipment.
In July 2017, the Opinions of the State Council on Strengthening the Implementation of Innovation-Driven Development Strategies and Further Promoting the Deepening Development of Public Entrepreneurship and Innovation (GF [2017] No. 37) were issued. This national document proposes that the NDRC should take the lead in developing the opinions on promoting the pilot use of the first set of major technical equipment, establishing sound systems for improving the R&D, testing and evaluation, pilot application of the first set of major technical equipment, perfecting supportive fiscal, financial, and insurance policies, clearly defining relevant bidding and procurement requirements, establishing incentive and protective mechanisms for pilot application to create a favorable policy and market environment. The Opinions were issued jointly by eight ministries and commissions, namely the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Justice, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission, the State Market Supervision and Administration Bureau, and the Intellectual Property Office.
2. There are 32 kinds of medical devices included into the directory of the first set of equipment.
10-odd kinds of equipment were included in the Directory of the First Set of Major Technical Equipment to Be Promoted for Wide Application prepared and issued by the Ministry of Industry and Information Technology. Medical devices are on the directory. According to the latest version of Directory of the First Set of Major Technical Equipment to Be Promoted for Wide Application 2017, 32 kinds of medical devices were included in the directory and benefiting from relevant supportive policies.
In order to promote the pilot application of the first set of products, the Opinions propose up to 38 specific supportive measures. These measures cover all relevant aspects, among which is priority and encouragement given to the procurement of the first set of innovative products in government procurement. It is also clearly stipulated that a bid inviting organization must not propose requirements on market share, use performance and so on for the products listed in the directory competing for bid, not refer to appraisal standards and technical parameters of specific products, and not restrict or reject the first set of products to compete for bid with unreasonable conditions.
1. National policies have been upgraded for supporting the first set of equipment.
A number of policies have been promulgated and great efforts have been made in order to promote innovation and development of made-in-China equipment, which are reflected in the establishment of dedicated technical and R&D projects, special review and approval of medical devices, and priority approval of medical devices in the field of medical devices. However, the homemade innovative equipment would not necessarily be widely applied following their R&D and appearance on the market despite their lower prices compared with imported counterparts. As they have not been put into use before, users have great concerns over using the first set of homemade equipment. In addition, some existing policies and mechanisms restrict the promotion and application of the first homemade equipment.
In July 2017, the Opinions of the State Council on Strengthening the Implementation of Innovation-Driven Development Strategies and Further Promoting the Deepening Development of Public Entrepreneurship and Innovation (GF [2017] No. 37) were issued. This national document proposes that the NDRC should take the lead in developing the opinions on promoting the pilot use of the first set of major technical equipment, establishing sound systems for improving the R&D, testing and evaluation, pilot application of the first set of major technical equipment, perfecting supportive fiscal, financial, and insurance policies, clearly defining relevant bidding and procurement requirements, establishing incentive and protective mechanisms for pilot application to create a favorable policy and market environment. The Opinions were issued jointly by eight ministries and commissions, namely the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Justice, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission, the State Market Supervision and Administration Bureau, and the Intellectual Property Office.
2. There are 32 kinds of medical devices included into the directory of the first set of equipment.
10-odd kinds of equipment were included in the Directory of the First Set of Major Technical Equipment to Be Promoted for Wide Application prepared and issued by the Ministry of Industry and Information Technology. Medical devices are on the directory. According to the latest version of Directory of the First Set of Major Technical Equipment to Be Promoted for Wide Application 2017, 32 kinds of medical devices were included in the directory and benefiting from relevant supportive policies.
In order to promote the pilot application of the first set of products, the Opinions propose up to 38 specific supportive measures. These measures cover all relevant aspects, among which is priority and encouragement given to the procurement of the first set of innovative products in government procurement. It is also clearly stipulated that a bid inviting organization must not propose requirements on market share, use performance and so on for the products listed in the directory competing for bid, not refer to appraisal standards and technical parameters of specific products, and not restrict or reject the first set of products to compete for bid with unreasonable conditions.