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"Shanghai Medical Device Manufacturing Enterprise Management representative Interim Measures," officially issued

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Recently, the Shanghai Food and Drug Administration formally issued the "Shanghai Medical Device Manufacturing Enterprise Management representative Interim Measures ." ( Hereinafter referred to as the "Rules" ) , the "measures " to define the management representative in the enterprise quality management system in an important position , given its quality management in the absolute right to speak , to ensure the effective operation of the quality system as a management representative duties to be cured .

Currently, medical equipment manufacturing enterprises in Shanghai has more than 940 medical device industry annual output value reached 200 billion yuan. There are more than 7,000 registered products , implantable medical devices more complete categories , sterile medical equipment with high technical content , a large class of imaging equipment products and vascular stents and other aspects of comparative advantage. In order to establish product quality management from the dominant position , the Shanghai Food and Drug Administration beginning from mid-2012 , began to research the drafting of the "measures" , and organized five training business managers on behalf of the " approach" first draft communication.

"Measures " clearly the main duties include the management representative organization's quality management system audit , to promote quality management training , to carry out the collection of information listed on product quality and reporting , is responsible for third-party inspection of the quality management system of communication , rectification and reporting and so on.

In order to protect the management representative to effectively perform their duties, "measures" Enterprises should establish clear measures for implementation of the relevant management systems , business executives and managers should be signed on behalf of authorization , supervision and requirements with the relevant departments within the enterprise managers representatives perform their duties, work to ensure the independence of the functions of the management representative and effectively implemented.

With reality, "measures" should be clear where the management representative and deputy general manager of the enterprise and other enterprises senior management, need to have three years of quality management or production , technical management experience , and has related production products related professional college or undergraduate professionals such as higher education .

"Measures " provides the management representative performance of its duties , it should be true and complete record of quality management activities . Should actively participate in various management representative will help improve enterprise quality management learning and training activities , acquire the relevant laws and regulations knowledge, and continuously improve the quality management level, management representative study and training annually during, not less than 20 hours .

"Measures " clearly states the responsibility for the quality of people 's responsibilities , rights and interests . Such as " approach" reporting obligations under Article VII wrote: EMR enterprise quality management system can not find the required effective operation, or product quality problems, and found that there are serious quality problems , they shall promptly report to the responsible persons . Of the relevant issues and quality problems failed to take timely corrective action , the situation may be reported to the relevant departments .

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