Shanghai: Medical industry must establish management representative

Recently, the Shanghai Food and Drug Administration formally issued the Interim Measures for the Administration of the Management Representatives of Shanghai Medical Device Manufacturing Enterprises. The "Measures" clearly define the special status of managers' representatives in the enterprise's quality management system, give them the absolute right to speak in quality management, and solidify the responsibility of ensuring the effective operation of the quality system as the representative of the manager.

At present, there are more than 940 medical device manufacturers in Shanghai, and the total output value of the medical device industry has reached more than 20 billion yuan. There are more than 7,000 registered products, and the categories of implantable medical devices are relatively complete. Aseptic medical devices have high technical content, and large imaging equipment and stents are advantageous. In order to establish the main position of enterprise product quality management, the Shanghai Food and Drug Administration started researching and drafting “Measures” from the beginning of 2012, and organized five sessions of management seminars for enterprise managers to exchange the first draft of the “Measures”.

According to the “Measures”, the responsibilities of the management representative mainly include the review of the quality management system, the promotion of quality management training, the collection and reporting of information on the quality of the listed products, and the communication, rectification and reporting of the third-party quality management system. .

In order to ensure that the management representatives can effectively perform their duties, the "Measures" make it clear that the company should establish a relevant management system for the implementation of the Measures. The person-in-charge of the company should sign a power of attorney with the representatives of the management, supervise and require the relevant departments within the company to cooperate with the representatives of the managers. Perform duties, carry out work, ensure the independence of the manager's representative functions, and implement them effectively.

In light of the actual situation in Shanghai, the "Measures" specify that the manager's representative should be the senior manager of the company's deputy general manager and other enterprises, have more than 3 years of experience in quality management or production, technical management, and have a professional or college degree in production-related products or above. Professionals such as academic qualifications serve.

The "Measures" stipulates that the representatives of the management should record quality management activities in a true and complete manner when performing their duties. During the post of manager, the representatives should actively participate in all kinds of learning and training activities that are conducive to improving the enterprise's quality management capabilities, timely acquire relevant laws and regulations, and continuously improve the level of quality management. The management representative shall not be less than 20 hours of study and training each year during the post.

The “Measures” clearly stipulates the responsibilities, rights, and benefits of the person responsible for quality, as stated in the Article 7 reporting obligations of the “Measures”, “When management representatives find that the enterprise quality management system cannot operate effectively according to regulations, or product quality occurs. Problems, and the discovery of serious quality problems, should be promptly reported to the person-in-charge of the company. If relevant issues and quality problems are not promptly corrected, they can report to the food and drug supervision department and relevant administrative departments."