9 policies of medical device industry in the first half of 2016

Wonderful introduction

In a flash, the majority of the half year of 2016 has passed, and many big events have taken place in the medical device industry in this half year. Looking back, we can only look forward to the future. Here are nine major policy events related to medical devices in the past six months.

Support domestic medical equipment

The 13th five-year plan proposes to build a new system of biomedical and high-performance medical device industry, and it is expected that large imaging equipment, high-value medical consumables and other high-performance medical devices will become the focus of future policy support. At the same time, the 13th five-year plan for national science and technology innovation focuses on the localization of medical devices. Heilongjiang, hunan, hebei and other local food and drug administrations have moved to issue policies on domestic medical devices. Localization of medical equipment is an important part of Chinese industry. In this supportive policy environment, many have seized the moment to act.

Focus on research and development and clinical urgent equipment, priority approval

In June, the state bureau issued the letter on soliciting opinions on the procedure of priority approval of medical devices, which gives priority to the approval of medical devices and medical devices that are urgently needed for clinical use and are included in major national science and technology projects or national key research and development plans. After reading the opinions, we will find that it coincides with the starting point of previous innovations in medical equipment. All industries are encouraging innovation, and medical devices are a rising industry. At present, the state has given corresponding financial support to the declaration enterprises that meet the requirements of "research and development of digital diagnosis and treatment equipment" and "research and development of biomedical materials and replacement of tissue and organ repair", which are the pioneers of the industry. Many companies have been burned by clinical trials of medical devices, and this policy is undoubtedly a ray of light for the industry.

Medical devices in 5 categories and 26 categories will be mainly developed

Plan on the division of key work departments to promote the healthy development of the pharmaceutical industry to accelerate the transformation and upgrading of medical devices. It focuses on the development of digital detector, superconducting magnet, high-heat capacity X-ray tube and other key components, precise surgical positioning and navigation, data collection and processing and analysis, biological 3D (3D) printing and other technologies. It is worth mentioning that the plan actively explores the research and development of medical devices based on the theory of traditional Chinese medicine. Recently, the Olympic Games in Rio Phelps cupping cupping seal suddenly detonated the cupping device of traditional Chinese medicine. Therefore, there is a reason for the promulgation of a policy, and every medical device policy should be studied carefully.

We will strengthen market oversight of the distribution of medical devices

In order to regulate the circulation order of medical devices and crack down on illegal business activities, the state food and drug administration has decided to carry out a centralized regulation on illegal business activities in the circulation field of medical devices. Subsequently, zhejiang, gansu, jiangxi, sichuan, shaanxi, qinghai and other provinces also actively responded to the provincial medical device market supervision. Judging from the current trend, the food and drug administration not only has a firm supervision on production, but also on market operation.

A catalogue of 250 new standards for the medical equipment industry was issued

Since 2016, the state bureau has issued a total of 250 new medical device industry standard catalogs, which are:

(1) announcement of the general administration on approving and issuing 64 standards of medical devices industry, including YY 0017 -- 2016 "metal bone plate for bone graft implant" (no. 129 of 2016);

(2) announcement of the general administration of China on the approval and issuance of 93 standards for medical equipment industry, including YY 0053 -- 2016 "hemodialysis and related treatment hemodialysis dialyzer, hemodialysis filter, hemofilter and blood concentrator" (no.74 of 2016);

(3) announcement of the state food and drug administration on approval and issuance of 93 medical device industry standards including YY 0065 -- 2016 "ophthalmic instrument slit lamp microscope" and 1 modification order (no. 25 of 2016). People in the industry are very concerned about the promulgation of standards, and product r&d and registration are all dependent on these standards. Meanwhile, timely understanding of the update of standards can also avoid a lot of legal risks.

Field inspection of clinical trials of medical devices

To April 2016, country promulgated the about clinical trials for medical devices notice on-site inspection procedures and inspection points of views, jiangsu, hunan, hubei, zhejiang, shandong, Shanghai, Beijing, and other provinces and cities have also launched a medical instrument clinical trial site inspection, its form is mainly include food safety supervision and inspection of the enterprises. Clinical trials are a time-consuming and expensive project for companies, but they also mean a wider range of medical devices and a bigger market, so the fda is tightening its grip.

Medical device flight inspection

Since 2016 YiXie flight check was not made ShengJu, for example: clove to Harbin medical instrument co., LTD., zhejiang guang kind medical instrument co., LTD., yangzhou huanyu medical instrument co., LTD, hubei xian Ming medical equipment co., LTD., a new day the (Beijing) medical equipment co., LTD., tianjin medical equipment co., LTD., zibo combo is day medical instrument co., LTD., flight check, shantou jinfeng medical equipment technology co., LTD., is the significance of the case for regulation registrant can learn: which does not conform to regulations, what are the main points of the examination, so as to avoid risk. Enterprises should use a positive attitude towards flying inspection, check out the problem, there is a way to solve; Passed smoothly, also can obtain the support of broad consumer.

Medical device cold chain management

On May 6, the state administration of industry and commerce (moc) issued a request for comments on the guidelines for the management of the cold chain (transportation and storage) of medical devices, most of which are based on in vitro diagnostic reagents. In vitro diagnostic reagents are supported by more and more laws and regulations this year, and in vitro diagnosis is gradually active in the field of medical equipment. In vitro diagnostic reagents in the medical equipment industry is bound to be a rising trend.

Medical device registration fee

Medical device registration fees in this industry has been a long story. Up to November 2015, fujian province published the medical device registration fee for the first time, and the medical device registration fee standards of all provinces were also published in 2016. So far, there are eight provinces, namely jiangxi, Shanghai, hainan, shandong, Inner Mongolia, Beijing and zhejiang. Opinions on the impact of medical device registration fees vary from person to person. Some people think that it increases the cost of the enterprise, while others think it reflects the value of the enterprise. Medical device registration fees on medical device prices and industry development is also not to be underestimated.

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