The State Food and Drug Administration recently issued four drafts of the policy for the purpose of accelerating the review and approval of clinically urgently needed drugs and medical devices, and encouraging domestic medical devices to replace imports. It is understood that since 2014, relevant departments have issued more than 20 policies to support the development of the domestic medical device industry. Among them, the localization of high-end medical equipment is the key to encourage the direction.
Policy encourages innovation and development
In order to encourage the innovation and development of pharmaceutical medical devices, the State Food and Drug Administration issued four major policies (draft for comments), including the “Policy on Encouraging Drug and Medical Device Innovation to Accelerate the Examination and Approval of New Drugs for Medical Device Listing†(Draft for Comment), Relevant Policies on Encouraging the Management of Clinical Trial Management of Pharmaceutical and Medical Device Innovation Reform (Draft for Comment), Relevant Policies on Encouraging Drug and Medical Device Innovation to Implement Life Cycle Management of Pharmaceutical Medical Devices (Draft for Comment) and “Encouraging Drugs and Medical Care†Relevant policies on equipment innovation to protect the rights and interests of innovators (draft for comments).
The contents of the four consultation drafts include accelerating the examination and approval of clinically urgently needed medical device evaluations; implementing the record-keeping system management for clinical trial institutions; and conducting clinical trials according to the submitted plan without response within 60 working days after acceptance of the clinical trial application; Clinical trial data; the system of listing license holders is widely implemented among drug and medical device licenses (registered persons) throughout the country, and the drug test data protection system is improved.
Zhao Qiaomin, a researcher at Guangzheng Hang Seng Medicine, told China Securities Journal that the four major policies encourage innovation from multiple perspectives such as the approval and use of medical devices and the protection of innovators' interests, which is conducive to the development of medical device companies.
Statistics from the Ministry of Industry and Information Technology show that the medical device industry reached a market size of 370 billion yuan in 2016, with a compound annual growth rate of 20.3% over the past six years. However, per capita medical device expenditures in the domestic market are much lower than in developed and regional markets. Per capita medical device costs in developed countries and regions are usually higher than $100, while per capita medical device costs in China are only $6. The medical device industry has a broad growth space.
Focus on supporting high-end medical equipment
Localization of medical devices and import substitution are the key directions for policy encouragement. Since 2014, more than 20 policies have been issued to support them. The policy encourages the direction of improving the innovation capability and industrialization level of medical devices, focusing on the development of high-performance medical equipment such as imaging equipment and medical robots, and persuading high-value medical consumables such as blood vessel stents, mobile medical products such as wearable and remote medical treatment.
Yu Mingde, president of China Pharmaceuticals, told China Securities Journal that the high-end medical device market is dominated by overseas manufacturers, including computed tomography (CT), color ultrasound systems, and digital subtraction angiography ( DSA), nuclear magnetic resonance (MRI), black and white ultrasound system, digital X-ray machine (DR), etc. The market size of each type of products is about 10 billion yuan. At present, more than 85% of the products are imported products, and the domestic replacement space is large.
Zhao Qiaomin believes that orthopedic consumables are an important part of medical high-end consumables. About 95% of the market share of orthopedic consumables is orthopedic implants. The market size of orthopedic implants is expected to reach 20 billion yuan in 2017. As the population ageing process accelerates and people's health awareness increases, the market size of orthopedic implants is expected to continue to grow.
From the global market, the largest market for orthopedic implants is joints, accounting for 54.7%, and the smallest is trauma. Due to the high technical barriers in design, materials and manufacturing processes, the domestic market is basically occupied by imported brands, and domestic companies are struggling to catch up.
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