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

A few days ago, the CFDA official website announced the "Announcement of 51 Enterprises Withdrawing 101 Medical Device Registration Application Items (2016 No. 146)". The announcement shows that since the CFDA issued on June 8, 2016 After the Notice of Spot Checking, as of August 25, a total of 51 enterprises withdrew 101 medical device registration applications. Please refer to the attachment at the end of the article for the withdrawal list. In addition to announcing the withdrawal list, the CFDA also announced the "Announcement on the Status of Clinical Trial Supervision and Random Inspection of 4 Medical Device Registration Application Items... 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.


The transformation of rehabilitation equipment for the aged

For China's 420 million middle-aged and elderly people over the age of 50, health has always been their biggest anxiety.


Analysis on the basic attributes and positioning of rehabilitation equipment standard in the new era

From the historical process of standardization development in China, standardization has always been a basic system for the modernization of national governance system and governance capacity. Standardization has played an important role in guaranteeing and providing technical support in improving product quality, standardizing market order, developing foreign trade, and promoting the sustained, rapid and healthy development of the national economy. The standardization work of rehabilitation equipment has experienced the "eleventh Five-Year Plan" to the "thirteenth Five-Year Plan", and has achieved leapfrog development in the construction of standard management regulations, organizational structure construction, and standard system construction. In recent years, the national standardization reform and the reform of the rehabilitation equipment regulatory system continue to advance, the rapid development of the rehabilitation equipment industry and the increasing demand for people's equipment, in the face of the new situation and new needs, a correct understanding of the basic attributes and positioning of rehabilitation equipment standards, scientific development, understanding and implementation of rehabilitation equipment standards, It is important to make it better serve and support the supervision and industry development of rehabilitation devices.


Compared with physical rehabilitation, psychological rehabilitation of patients is also particularly important

There are many departments in the hospital, and some departments, if you just listen to the name, it is not clear what the department is, or what kind of patients. Rehabilitation medicine is one of the most typical examples.


Why is the construction of rehabilitation hospitals becoming more and more common nowadays

China's hospital construction has experienced the transformation and expansion of large general hospitals, the peak of specialized hospitals and the rise of private hospitals. At present, there is a new type of medical institution - rehabilitation hospital has become an upsurge


Rehabilitation is essential for nursing institutions

In recent years, due to the "D-combination" pension model proposed by the Health Development Planning Committee, the rapid development of the domestic pension industry has led to the emergence of a variety of pension institutions. Although the number of rehabilitation hospitals has developed rapidly, the scale of some pension institutions seems not small, but its functional positioning and quality are far from reaching the true "maintenance and maintenance combination". In the final analysis, the current elderly care institutions lack of attention to rehabilitation medical care, and many rehabilitation services provided by elderly care institutions are only "put on the shelf", but in the future, rehabilitation services will hold the lifeblood of elderly care institutions!

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