In the blink of an eye, the large half of 2016 has passed, and many major events have occurred in the medical device industry during this half year. Looking back at the past, we can look forward to the future. The following are nine major policy events related to medical devices in the past six months.
1. Support domestic medical devices
The “13th Five-Year Plan” proposed to build a new system of biomedicine and high-performance medical device industry. It is expected that high-performance medical devices such as large-scale imaging equipment and high-value medical consumables will become the focus of future policy support. At the same time, the "13th Five-Year" National Science and Technology Innovation Plan focuses on the localization of medical devices. Local drug regulatory bureaus such as Heilongjiang, Hunan, and Hebei have taken action to introduce relevant policies on domestically produced medical equipment. The localization of medical equipment is an important part of China's industry. Under the environment supported by this policy, many people grasped the opportunity and shot.
2. Priority approval for key R&D and clinical urgently needed devices
In June, the National Bureau issued the “Letter on Obtaining Opinions on Priority Approval Procedures for Medical Devices”, which will give priority approval to medical devices that are included in major national science and technology projects or national key R&D plans and medical devices that are urgently needed in clinical practice. After reading the "Opinions" throughout, you will find that the starting point of the innovative medical equipment is exactly the same. Various industries are encouraging innovation, and the sunrise industry, medical devices, is not to be outdone. At present, the state has provided corresponding financial support to the qualified enterprises of the two types of national key R&D equipment "digital medical equipment development", "biomedical materials research and development and replacement of tissue organ repair", these are the pioneers of the industry. Many companies are scorched by medical device clinical trials, etc. This policy is undoubtedly a dawn of the industry.
3. 5 major categories and 26 minor categories of medical devices will focus on development
The "Division of Work of Key Work Departments on Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry" accelerates the transformation and upgrading of medical devices. Focus on the development of key components such as digital detectors, superconducting magnets, high heat capacity X-ray tubes, surgical positioning and navigation, data acquisition processing and analysis, biological three-dimensional (3D) printing and other technologies. It is worth mentioning that the "Proposal" wrote to actively explore the research and development of medical devices based on Chinese medicine theory. Recently, the cupping mark of Phelps of the Rio Olympics suddenly detonated the cupping device of traditional Chinese medicine. Therefore, there is a reason for the promulgation of a policy. Every medical device policy must be carefully figured out.
Fourth, strengthen market supervision in the field of medical device circulation
In order to standardize the order of medical device circulation and severely crack down on illegal business operations, the State Food and Drug Administration has decided to carry out centralized rectification of illegal business operations in the field of medical device circulation. Immediately afterwards, Zhejiang, Gansu, Jiangxi, Sichuan, Shaanxi, Qinghai and other provinces also actively responded to the medical device market supervision of their provinces and cities. Judging from the current trend, the Food and Drug Administration not only strictly monitors production, but also does not relax the supervision of market operations.
V. 250 new medical equipment industry standard catalogs promulgated
Since 2016, the National Bureau has issued a total of 250 new medical device industry standard catalogs, namely:
(1) Announcement of the General Administration of the People's Republic of China on the approval and release of 64 medical device industry standards including YY 0017-2016 "Bone Joint Implant Metal Bone Plate" (2016 No. 129);
(2) Announcement of the General Administration of the People's Republic of China on the approval and release of YY 0053-2016 "Hemodialysis and Related Therapies, Hemodialyzers, Hemodiafiltration Filters, Hemofilters, and Blood Concentrators" and other 93 medical device industry standards (2016 No. 74 (3) Announcement of the State Food and Drug Administration on the approval and release of 93 medical device industry standards and one amendment list (No. 25 of 2016) including YY 0065-2016 "Ophthalmic Instruments Slit Lamp Microscope".
People in the industry are very concerned about the promulgation of standards. The R&D and registration of products are dependent on these standards. At the same time, timely understanding of the update of standards can avoid many legal risks.
6. On-site inspection of clinical trials of medical devices
As of April 2016, the National Bureau issued the "Notice on Obtaining Opinions on On-site Inspection Procedures and Key Points for Clinical Trials of Medical Devices". Jiangsu, Hunan, Hubei, Zhejiang, Shandong, Shanghai, Beijing, and other provinces and cities have also launched clinical medical devices. The on-site inspection of the test mainly includes the inspection by the Food and Drug Administration and the enterprise self-inspection. Clinical trials are a time-consuming and costly project for enterprises, but also mean that the medical device product category is more abundant and the market is getting bigger and bigger, so the Food and Drug Administration has stricter supervision on it.
Seven, medical device flight inspection
The flight inspections of medical equipment from 2016 to the present are really innumerable. For example: For Harbin Clove Medical Devices Co., Ltd., Zhejiang Guangci Medical Devices Co., Ltd., Yangzhou Huanyu Medical Devices Co., Ltd., Hubei Xianming Medical Devices Co., Ltd., Tianxinfu (Beijing) Medical Devices Co., Ltd., Tianjin Zhengtian Medical Devices Co., Ltd., Zibo Kangbei Medical Devices Co., Ltd. flight inspections, Shantou Jinfeng Medical Devices Technology Co., Ltd. The meaning is to learn from the experience: what does not meet the requirements of the regulations, what are the main points of the inspection, so as to avoid risks. Enterprises should take a positive attitude towards flying inspections. Only when problems are detected can they be resolved; if they pass successfully, they will also get the support of consumers.
8. Cold chain management of medical devices
The National Bureau issued a solicitation for comments on the "Guidelines for the Management of Cold Chains (Transportation, Storage) of Medical Devices" on May 6. Most of the management of cold chains for medical devices is for in vitro diagnostic reagents. In vitro diagnostic reagents are supported by more and more regulations this year, and in vitro diagnostics are gradually becoming active in the public's field of vision in the medical equipment industry. In vitro diagnostic reagents must be a trend in the medical equipment industry.
Nine, medical device registration fees
Medical device registration fees are a long-standing issue in this industry. As of November 2015, Fujian Province announced the registration fees for medical devices. In 2016, the standards for registration fees for medical devices in various provinces were also announced. So far, there are eight provinces in Jiangxi, Shanghai, Hainan, Shandong, Inner Mongolia, Beijing, and Zhejiang. The view on the impact of medical device registration fees is that the benevolent sees the benevolent and the wise sees the wisdom. Some people think that the cost of the enterprise is increased, and some people think that the value of the enterprise is more reflected. Medical device registration fees are also not to be underestimated for medical device prices and industry development.