GMP into a new era of medical devices into the enterprise a higher threshold
Author: witchRecently, the State Food and Drug Administration (SFDA) issued a "Medical Device Good Manufacturing Practice (Trial)" (hereinafter referred to as "normative"), a total of 13 chapters, used in medical equipment design and development, production, sales and service of all process, since January 1, 2011 into effect. Meanwhile, SFDA has also simultaneously introduced the "Medical Device Good Manufacturing Practice Inspection Regulations." This means that the real beginning of China's medical device GMP into the era.
"In the context of new medical reform, the strengthening supervision and management of medical device manufacturing, medical device manufacturing standard quality management system is to protect the public not to use armed security, the State Council promulgated two regulations in the Chinese medical device manufacturing quality management is encouraged by the is also a spur. can be said that this is to promote the gradual maturity of China's medical device industry, the specific performance. "Zhejiang Medical Device Industry Association, XU Pei-chuan accept the" Medicine Economic News, "says an interview.
Risk Control stressed that "full"
In recent years, foreign-funded medical equipment giants are pegged in the low-end of China's medical equipment market, the domestic medical equipment companies constitute a great pressure. To this end, recently introduced the "norm" gives clear guidance that, as a quality management system is an important component of the enterprise should increase production standards in the production of the entire process of the implementation of risk management.
XU Pei-Quan said, compared with the previous risk control, this time focused "whole" word. In the past, many enterprises lack of knowledge of risk management, in particular SMEs, are often passive as the standard, "norms" will urge enterprises to increase software and hardware construction, to promote local products more secure and effective.
"Risk control is the whole industry, highlighting the urgent need for progress, especially for sterile and the implantable medical device companies plant size and production capacity, quality management and risk management requirements such as whether the suit." Analysts believe that, after a years of transition, overall control will enter a stage of practical operation, the next issue of implementation will become the focus of attention.
Reporters also learned that the "norms" to define the production enterprise shall establish and maintain records of each batch of products. Medical equipment production records should meet traceability requirements, and indicate the number of production volume and storage, etc., to promote the medical device GMP inspection.
"Adhering to traceability requirements, improve production quality standards are the only way to protect." Shenzhen Anke High Technology Co., Ltd., executive vice president of Wang Bi-war, told reporters. In his view, is now a prime time to build national brands.
Wang Bi-war explained, because the current foreign medical device is only by cutting prices on existing products to Stock Watch the Chinese market; with China's grass-roots operation of medical equipment is limited, will allow foreign investors to enter the medical device market, the advantages of a low-end fashion difficult to embody. "In a sense, (" norm ") on the domestic enterprises is a kind of protection."
At this point, Zhejiang Ling-Yang Hu Jun, general manager of Medical Equipment Co., Ltd. fly quite agree. However, he also expressed some concern: "" norms "right to require the approval of new products, a little high."
Close to international standards
Learned that medical device manufacturers for product registration and re-registration for the first time, it should apply for medical device GMP inspections, while the "norm" is also integrated into the international ISO13485 standard and so on.
XU Pei-Quan believes that the establishment from the source of normative standards related to manufacturing enterprises and restraint mechanisms, a comprehensive medical device manufacturing enterprises to enhance the overall quality and level of supervision and management of medical devices is a great advantage. "It can be said to enhance the production of medical equipment management standards and international standards of the Chinese medical device company based on the local community, positive to the world the only way."
In this regard, Mindray Bio-Medical Electronics Co., Ltd. Ling-Li Dong, director of technical regulations also believed that "normative" part of the terms of reference of the international practice of ISO13485 certification standards, and actively move closer to the QSR standards will be China's medical device quality management system to laws and regulations the form of the establishment down, is to try and first experience with international standards.
However, some people think that, in view of improving the access threshold and the content of some provisions of the principles and guidance too, operability is not strong, software management is not specific enough, would have difficulty forming a combined force.
Wang Bi-war, said the adoption of ISO13485 certified companies can only required replacement, while the new entrants into the business will face higher entry threshold test. Timely amendments to the enterprise's own process management, and in 2010 4 to 5 months to complete process management solutions for small and medium enterprises is still a test.
"Of course, industrial upgrading, survival of the fittest is inevitable. For example, the" norm "clearly stipulates that manufacturers should set up procedures for control of product identification and documented clearly in the whole production process, the appropriate way to identify the product, in order to identify other content, it is overlooked by many companies present. "Hu Jun flying that follow the market trend, to try to international standards should be affirmed, but in practice the requirements to upgrade hardware and software should be gradual, particularly for new products should be given to policy support.
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