Production supervision in the medical device, the Guangdong Provincial Food and Drug Administration's innovative concept in the national food and drug supervision system for all to see: in 2007 the first medical device manufacturers to implement quality management system review system and promulgated in 2008 "medical equipment in Guangdong Province production quality system review Interim Provisions "; beginning of 2009, the Guangdong Provincial Bureau took the lead again focus on monitoring the implementation of enterprise managers on behalf of medical device manufacturing management system, the same year in October, the scope of the system, the province has covered the second and third class medical device manufacturer. What is the Guangdong Provincial Bureau of new initiatives to promote frequent? Innovative medical device manufacturing in Guangdong Province gave and regulatory What are the changes? Special Issue interview, the Guangdong Provincial Bureau is responsible for medical equipment who will we answer it.

    Situation calls for innovative regulatory thinking

    Reporter: Medical Device Manufacturing Enterprise Quality Management System review system has just introduced three years, the Guangdong Provincial Bureau why they put managers on behalf of management system

    Person in charge: the two systems can be described as "progressive" relationship, the implementation of enterprise managers on behalf of management system is to better ensure that medical device manufacturers quality management system effectively. Device Manufacturing Industry in Guangdong Province to implement the quality management system has indeed received some success, but there are some problems. Year in 2007,2008 quality system review and random inspection of enterprises focused on monitoring the process of discovery, some just passed the quality management system assessment companies, the effectiveness of certain operating system problems, that although the system through the assessment, but production practice and did not meet standard management, system operation form of assessment and practice "mismatch." Of course, this Guangdong Province, the status of medical device manufacturing industry has a lot. Guangdong Province, medical device manufacturers of all types, more than 1,600 of these business owners, some original flow of trade in medical devices, some cross into the area of medical devices. Since they are not familiar with or do not fully understand the medical device laws and regulations and technical standards, quality management in medical device manufacturing decision-making process, tend to "efficiency, efficiency first" ranked first, "Quality is life" is often just talk about it. The business-related professional and technical personnel are often no right or inability to intervene on the quality of management decisions, which lead to internal quality control is unclear, the problem continued.

    Medical device manufacturers a problem which is not a one moment formation, even if the high frequency range of supervision and inspection and other means to intensify supervision, it is difficult to fundamentally solve. There is an urgent need to explore new, more effective supervision. To this end, we broaden the regulatory thinking, reference to the U.S. FDA's CFR820 quality management system regulations and "medical device quality management system for regulatory requirements," refer to the current system of drug quality attorney, combined with the actual situation, through a large number of research listen to the industry Yixian, the Guangdong Provincial People's Government review, first published in the country, "Guangdong Province, on behalf of management of medical equipment managers approach" (hereinafter called "measures"). "Measures" on behalf of the core is to promote the full implementation of management responsibilities, so the "way" is not only defined the scope of authority and supervision of managers on behalf of treatment, and highlights the responsibilities and rights management representative.

    Reporter: The introduction of this system mainly want to solve the problem?

    Leader: We have implemented management representative management system is designed to strengthen the business managers on the management of quality management system. Corporate leadership, attitudes about the direct effect of the quality management system to run, if top management weekday indifferent, without the right quality of management responsibility and actual responsibility for the right combination together, that it will not effect the actual management to have any effect. To this end, the "measures" required top management to implement corporate quality management system as a major issue, and to the specific responsibilities of departments and responsible persons to deepen understanding of system documents, personal charge of the implementation, management and monitoring into their daily work, improve The department's emphasis on quality management system to ensure the continued effective operation of quality management system. By having appropriate qualifications and ability of people to serve as representatives of corporate managers, on behalf of a clear management responsibility for management representatives to play a better role in monitoring the quality of production, so that enterprises and gradually establish a clear mandate, powers and responsibilities consistent with quality management system.

 New measures to verify the practical effect

    Reporter: after the introduction of the new system, the Guangdong provincial bureau is how to promote it?

    Leader: For medical device manufacturers, the management representative management system is a new thing. To this end, mainly from Guangdong Provincial Bureau to strengthen guidance and management to proceed, construction of "the Government to promote enterprise initiative, a multi-pronged" the implementation of the system, and promote the production manager on behalf of management system implementation.

First, strengthen Publicizing and guidance for managers on behalf of enterprises provides a powerful management system. Understanding of this work, some enterprises have bias, that managers have too much power and responsibility on behalf of, meet the qualification requirements for personnel are not many, so they are reluctant or afraid to carry out this work. In this regard, we take charge of the enterprise to convene meetings with the exchange, take the initiative to talk business face to face so many ways to help businesses understand the "way" of spiritual essence and basic requirements of the enterprise legal representative, and staff recognize that the implementation of "measures" the feasibility of , necessity and importance for the smooth progress of this work has laid a solid foundation.

Second, strengthen supervision and management to ensure effective implementation of the management representative management system. Conscientiously implement the guiding business managers on behalf of management system, we established a complete monitoring system, improve the management of the implementation of the system. In practice, we implemented a system of assessment and application enterprise applications, "Medical Device Manufacturing Enterprise License" business to be submitted by the Council's review of "medical equipment managers on behalf of the record book" of measures to managers on behalf of the record system and medical equipment manufacturing enterprise quality management system assessment, permit application business combination, effectively promoted the "measures" implemented; while the managerial operation of the regime on behalf of management as an important part of routine monitoring, and integrated use permit on-site inspection, quality management systems assessment, flight inspection and monitoring tools to track inspection, overall supervision and guidance for business managers to create a good performance of their duties on behalf of the external environment, management representative to ensure the effective implementation of the management system.

 Reporter: So far, the implementation of new measures more than 1 year, and effects?

Leader: As of now, the province has more than 980 second and third medical device manufacturers was filed on behalf of managers. Over the past year, through the implementation of the system, the province's medical device manufacturer's quality management system, operation of a new look, quality management system continued to strengthen the position and role, continue to streamline the quality management structure, quality management, upgrade to a new grade level.

  First, the enterprise quality management responsibilities to further clarify the responsibility of quality awareness has greatly improved. Management systems manager, serving as manager on behalf of the representative of conditions, responsibilities and authority to undertake the work done has specific requirements on the enterprise in the managers have a clear choice of representatives of the Biao Zhun, Ji Da enhance the management representative the status of a management representative to ensure the independence and authority, so that management representative to better monitor the quality of play the role of the production. At the same time, enhance the quality of enterprise management personnel at all levels of quality awareness and responsibility to further strengthen the business management decision-making on the quality management system awareness of the importance, the responsible persons of quality awareness has greatly improved.

 Second, the enterprise quality management system to refine the role of markedly enhanced. Implementation of the system manager on behalf of management responsibilities to promote enterprises to establish a clear and structured quality management structure, effective to streamline the fragmented relations solved irrational distribution of duties and rights issues, to affect the production quality of Mei Yi links are responsible to ensure quality management and quality control of harmonization. As the responsibility for enterprise quality management be implemented at every level, quality management, order more standardized, the more perfect management system and records, quality management has improved significantly.

Third, manufacturers and regulatory interaction was monitoring the efficiency and effectiveness improved. Regulatory supervision over enterprises is often unilateral. In view of this, "approach" provides managers should take the initiative on behalf of communication and coordination with regulatory authorities in each of the two must be reported to the regulatory quality management system operation. To play a management representative by the initiative and enthusiasm for business and regulators to provide the best contact between the platform and realize the enterprises to participate in monitoring. At the same time, regulators have to understand the detailed product and company quality management system operation, and to make all the necessary regulatory or rectification request, to promptly resolve the various policies and regulations to understand business, convergence and other new issues, improve regulatory efficiency. It is these tangible results, so that entrepreneurs recognize the new measures, regulators more confidence.

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