The " Medical Device Management Quality Management Regulations" (hereinafter referred to as "Specifications") was announced on December 12, 2014 and will be implemented as of the date of promulgation. The "Specifications" consists of nine chapters and sixty-six articles covering the procurement, acceptance, storage, sales, transportation, and after-sales services of medical devices, and effective quality control measures are set for each link, requiring enterprises to establish sound quality. Management system to ensure quality and safety in the business process. The issuance and implementation of the "Specifications" can effectively strengthen the quality management of medical device operations, standardize the operation of medical devices, and ensure the safety and effectiveness of public use of machinery.
It is an international practice to implement quality management practices for the production and operation of pharmaceuticals and medical devices. The issuance and implementation of the "Code" indicates that China's medical device management has gone from extensive to fine, from static management to dynamic management.
Full-service enterprise quality management
The "Specifications" is the quality management of the entire process, covering the initial links of medical device management until the final after-sales service. The "Code" infiltrates quality management into every aspect of medical device management, and forms the quality management of the whole process of operation.
The "Code" is aimed at all medical device operators. Whether the enterprise is in a prosperous city or a remote village or a combination of urban and rural areas, it must meet the requirements of the "Code", thus forming the quality management of the whole business.
After the implementation of the "Code", it is conducive to eliminating the quality hazards in the operation of medical devices. Through requirements for personnel qualifications, facilities and equipment, rules and regulations, and procurement acceptance, control various points that may affect the quality of medical device operations, eliminate potential safety hazards, and ensure the safety and effectiveness of medical devices.
Improve corporate management
For medical device operators, the implementation of the "Code" is conducive to promoting the improvement of corporate management and the transformation of business philosophy.
Enterprises are profit-seeking, medical devices are related to the safety and health rights of the workers. The implementation of the "Code" is conducive to promoting the transformation of the business philosophy of medical device management enterprises, so that enterprises from the profit-oriented, to the interests and quality. In addition, the "Code" covers all aspects of medical device management, and provides effective quality control measures for each link. Enterprises in accordance with the "Specifications" to manage medical device business operations will greatly improve the quality management level.
Secondly, the "Code" is conducive to improving the quality and responsibility of practitioners. The "Regulations" stipulate the qualifications and duties of the legal representative, responsible person and quality management personnel of the enterprise. At the same time, it also stipulates that the enterprise shall conduct pre-job training and continuation on the quality responsibility person and personnel in various positions related to their duties and work contents. Education and training, establish training records, and pass the examination before they can be employed. The training content should include relevant laws and regulations, medical equipment professional knowledge and skills, quality management system, responsibilities and job procedures, etc., which is conducive to improving the quality and responsibility of practitioners.
Once again, it will help strengthen the international competitiveness of enterprises. China is a member of the World Trade Organization, and the opening of the market has intensified competition among enterprises. At present, China's medical device management enterprises are still in multiple, scattered and small steps. With the intensification of market competition, medical device management will also move from extensive to intensive, and enterprises will continue to optimize and scale. Support for the Code is needed in the process of enterprise optimization and scale. The implementation of the "Code" is conducive to the elimination of those enterprises with loose management and low quality awareness, the protection of formalized and large-scale enterprises, the promotion of enterprises to become bigger and stronger, and the enhancement of the international competitiveness of enterprises.
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