Standard of our country medical devices builds current situation investigation

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.....Standard of our country medical devices builds current situation investigation

—— perfects technical standard system around product quality problem

Complier: In recent years. Industry of our country medical devices presents the trend that gives rapid development, people also raised taller requirement to using the security of medical devices and effectiveness. However, long-term since, the product of a few medical devices pledges capacity issue is perplexing industry of our country medical devices all the time develop. Product of medical devices is in design, development, production, use wait for link to be badly in need of strict safe level. Accordingly. Build system of perfect standard of technology of medical devices very pressing. Be based on such setting. The article is on the base that to the issuance of standard of our country medical devices the current situation has analytic study. The problem that to how be being solved active standard exists offerred constructive opinion.

As the unifinication of the rapid development of industry of medical devices and global economy, product of our country medical devices is on world stage stage by stage. Standard of medical devices shows its indispensable main effect more and more. Nearly ten years, our country begins to quicken the pace that conforms with international, cite increasingly international standard. The standard circumstance that releases nearly 5 years especially achieves the fastigium that conforms with international, the meeting year after year that the standard of international medical devices that our country place attends talks increases. Adopt the interconnected system of active standard and international standard

One, make product of our country medical devices in the world competition ability increases increasingly. Had benign stimulative effect to the development of industry of our country medical devices.

Standard of our country medical devices releases a circumstance

Since from 1984 standard of the first medical devices is released, below the joint efforts of various controller and technical personnel. Standard of our country medical devices presents development the rapid, trend that updates ceaselessly. Standard measure increases. Enclothe a face to expand, satisfied country and wholesome industry basically to be opposite currently standard demand. In the meantime, standard system is complete with each passing day. Standard measure also rises in year after year, in safety of product of safeguard medical devices ground of significant aspect utmost produced effect. End in Feburary 2008. Standard of our country active medical devices adds up to 718. Standard of its China home 162, occupation standard 556. Compulsive standard 472, recommend a level 246: Add newly standard and replace updated standard every, year have increase. Up to now, replace newer standard 623, hold overall level 86. 8 ％ , among them nearly 6 years (2002~2008) replaces a standard 188, 30 what hold newer sum total. 2 ％ : Clear rectify revocatory standard 30.

Mark age circumstance: Through standard of medical devices cleared 1999 rectify special job, level of active medical devices is at present medium, mark age is the shortest for 1 year, the longest for 24 years, mark age the standard of 4 years of less than 221, 30 what hold sum total. 78 ％ , average bid age 8. 19 years.

Cite circumstance: In the standard that issues every year before 2000. Use, cite international standard place occupies scale to wander in inferior level all the time. Later, standard of our country medical devices is being used, cite the state that standard field presents a rapid development. End by 2005, adopting equation of our country medical devices, revise use, equivalent is used, blame equivalent uses international level 275, 39 what hold overall level. 2 ％ ; After using 96 years (contain 96 years) international standard 229, 83 what hold the national level sum total that uses international level. 3 ％ , among them 2001 ～ 2005. The national level that uses international level 159, occupy use entirely, cite 57 standard. 8 ％ .

The problem that standard of go ahead of the rest exists and settle strategy

One, partial level is aged, standard system still needs to be perfected further.

To healthy attention as the public degree is increased, the rapid development of industry of medical devices, raised taller requirement to standard of our country medical devices. Show level share level existence is aged problem, cannot have satisfied the requirement of the industry. The development of industry of our country medical devices was restricted on certain level. In the meantime, standard system also is existing structure, project and technical standard edit the inadequacy that waits for a respect. Need to be perfected further.

2, the standard releases existence lag sex.

Develop in information height. Product of medical devices increasingly diversity, emphasize a function changing today, seasonable sex is gifted very principal port. Long-term since, because be mixed to standard of quality of medical devices,detect technical research lack is enough take seriously. Bring about our country to exist in advanced country of respect of monitoring of safety of quality of medical devices and abroad bigger difference. If laws of some check proved recipe are very backward, the law of check proved recipe of appliance of operation of certain medical treatment still stays in on century the level of 50 time. Because examine,the method lacks scientific sex. Factitious element is right examine the impact of the result is very big.

Be aimed at afore-mentioned problems. The author puts forward to settle strategy below to the construction of system of standard of medical devices.

One, the industry characteristic that holds medical devices. Highlight product reliability.

To medical devices. Security and effectiveness are the mainest demand. How to reach mark of this two projects? The author thinks, ensuring product reliability is important way. Product of medical devices because its characteristic, requirement must can work reliably first and last, although the addition as use time, product function is reduced somewhat, still also can make sure safety is effective. Function index the product with advanced, not high reliability is no point. This shows, dependability will become the chief quality target of product of medical devices. Supervisory management board of national provision medicines and chemical reagents was released 2000 " the risk management application to medical devices " (YY ／ T0316-2000) . Replace T0316-2003 of standard YY ／ at was being released 2003, raised the initial requirement that dependability studies to domestic medical devices. Later, the national level of current requirement and occupation standard issue functions of a series of concerned medical devices and security in succession. Taller dependability requirement raised in the respect such as electric safety and biology evaluation. Of course, from at present the case of product of our country medical devices looks, in the security that still more dependability standard needs to introduce a product is designed and be being analysed.

2, the special orgnaization that builds a technology to superintend, unite administrative program.

A when quality of medical devices revitalizes very important facet is to build system of perfect standard of technology of medical devices and administrative standard system, carry out in the round seriously carry out. Build technical skill to superintend an orgnaization, undertake unity administrative planning to standard issuance, can adjust our country well frame of present standard of medical devices, and can stand in the angle that be spent higher and develops have science government to standard of medical devices. And create relevant expert group, the organization develops system of standard of medical devices transverse (domestic and international comparison) with fore-and-aft (the development of standardization and mission) investigation and study, make the standard system that is helpful for development of industry of our country medical devices, raise its mission and target.

3, raise a level but acquired character.

Current, standard of our country medical devices is to be released on the website dispersedly. The industry is not light systematization ground is obtained, this used a standard to cause very big inconvenience to the enterprise. To can raise a level but acquired character, make the standard gets the execution of older rate, answer active standard to undertake arranging pool, release to fixed website with open form is published or be being united.

4, continue to quicken internationalization pace.

The whole world coordinates a working group to knit the tough effort through several years. Wrote the basic principle with safety of medical devices and accepted function 1999 eventually. Be record in by management of quality of ISOTC210 medical devices and committee of current requirement technology in ISOTRl6142. Current, our country still includes to be in without such basic principle corresponding medical devices is general in requirement standard. Our country should take an active part in the communication of field of standardization of international of medical devices and activity. Know the development way that the medical devices on international standardizes, more ground and international conform, make product of medical devices more safe and effective. Also create better condition to enhance the competition ability of product of our country medical devices at the same time.