Since August 2009, the Hainan Provincial Food and Drug Administration has adopted various measures such as centralized rectification, improvement of barriers to entry, and strengthening of induction training, and has strengthened the supervision of the medical device market with remarkable results. At present, after special rectification, medical device companies have a completely new look, have a higher level of corporate management, and the market has improved significantly. 179 companies with poor conditions were written off, accounting for 43% of the total number of enterprises before the rectification. Measures taken by the Bureau:
The first is to conduct market rectification in a down-to-earth manner and severely crack down on violations.
In addition, more than 200 operating companies with unauthorized changes in registration and warehouse addresses, reduced office and storage conditions, and unacceptable purchase and sales records were ordered to make rectification within a time limit, and 87 companies that had not been rectified overdue were written off.
The second is to improve the access threshold and promote the improvement of the management level of the company.
In connection with Hainan’s actual situation, with reference to the relevant standards of most provinces and cities in the country, with the aim of standardizing the market, in 2009, the old “Inspection and Acceptance Criteria for Hainan Medical Equipment Operation Enterprises†was revised. The new standard has improved the quality management personnel and quality. The qualifications of the person in charge of the management agency, requirements for business premises and storage conditions, and the content of personnel training and continuing education. The Bureau requested that enterprises that have obtained the “Medical Device Operation Enterprise License†should carefully rectify the new standards and organize inspection and acceptance on July 1, 2010, and cancelled 92 overdue rectification business enterprises. At present, the entire All provincial medical equipment operating companies have reached new standards, and the quality of medical equipment has greatly improved.
The third is to strengthen induction training and improve the business quality of employees.
In order to improve the quality of employees, the training courses for employees of medical device companies were held and experts were invited to teach. At present, 3 training courses have been held. More than 700 people have been trained, and 670 have passed exams and got employment cards.
The fourth is innovative work ideas and exploration of long-term mechanism construction.
In addition to improving access barriers, the long-term mechanism has also been explored in four areas. The first is to establish a legal representative interview system. A face-to-face interview was conducted with newly established and changed legal representative companies, which mainly explained the laws and regulations of medical devices, Hainan's regulatory policies, and the company's standardized management, and further improved the awareness of the law-abiding people and the integrity of corporate leaders. Followed by the start of smart IC card system management. Starting in the second half of 2010, it is planned to implement the implementation of smart IC card systems for medical device practitioners, and management personnel can analyze the collected data through the management system to implement the management of IC cards for employees. The implementation of this system has greatly facilitated the daily supervision and training management of employees. Again, it is to explore the third-party logistics model for medical devices. In view of the widespread phenomenon of small and scattered medical device manufacturers in Hainan, to reduce the cost of medical device warehousing and to further standardize the warehousing management of medical device manufacturers, the “Provisional Regulations for the Administration of Medical Devices Entrusted Storage and Distribution in Hainan Province†was formulated to encourage the establishment of Hainan Province. A unified warehouse for third-party medical device logistics will be used to centralize and standardize the management of the warehouses of some medical equipment with zero-inventory or small-scale, or warehouse-distributed medical device operators. At present, two companies have been approved to carry out third-party logistics and warehousing of medical devices. The last step is to establish a follow-up inspection system. In order to strengthen the supervision and inspection of medical device management companies, a follow-up inspection system has been established. On the basis of the previous stage of renovation and the acceptance of new standards, 100 key companies were selected, and inspections were carried out not less than once a year. The new medical device manufacturers issued a permit for medical device operators. A supervision and inspection will be arranged within 6 months from the date of the permit, and will be included in key inspections of key enterprises during the second year.
The first is to conduct market rectification in a down-to-earth manner and severely crack down on violations.
In addition, more than 200 operating companies with unauthorized changes in registration and warehouse addresses, reduced office and storage conditions, and unacceptable purchase and sales records were ordered to make rectification within a time limit, and 87 companies that had not been rectified overdue were written off.
The second is to improve the access threshold and promote the improvement of the management level of the company.
In connection with Hainan’s actual situation, with reference to the relevant standards of most provinces and cities in the country, with the aim of standardizing the market, in 2009, the old “Inspection and Acceptance Criteria for Hainan Medical Equipment Operation Enterprises†was revised. The new standard has improved the quality management personnel and quality. The qualifications of the person in charge of the management agency, requirements for business premises and storage conditions, and the content of personnel training and continuing education. The Bureau requested that enterprises that have obtained the “Medical Device Operation Enterprise License†should carefully rectify the new standards and organize inspection and acceptance on July 1, 2010, and cancelled 92 overdue rectification business enterprises. At present, the entire All provincial medical equipment operating companies have reached new standards, and the quality of medical equipment has greatly improved.
The third is to strengthen induction training and improve the business quality of employees.
In order to improve the quality of employees, the training courses for employees of medical device companies were held and experts were invited to teach. At present, 3 training courses have been held. More than 700 people have been trained, and 670 have passed exams and got employment cards.
The fourth is innovative work ideas and exploration of long-term mechanism construction.
In addition to improving access barriers, the long-term mechanism has also been explored in four areas. The first is to establish a legal representative interview system. A face-to-face interview was conducted with newly established and changed legal representative companies, which mainly explained the laws and regulations of medical devices, Hainan's regulatory policies, and the company's standardized management, and further improved the awareness of the law-abiding people and the integrity of corporate leaders. Followed by the start of smart IC card system management. Starting in the second half of 2010, it is planned to implement the implementation of smart IC card systems for medical device practitioners, and management personnel can analyze the collected data through the management system to implement the management of IC cards for employees. The implementation of this system has greatly facilitated the daily supervision and training management of employees. Again, it is to explore the third-party logistics model for medical devices. In view of the widespread phenomenon of small and scattered medical device manufacturers in Hainan, to reduce the cost of medical device warehousing and to further standardize the warehousing management of medical device manufacturers, the “Provisional Regulations for the Administration of Medical Devices Entrusted Storage and Distribution in Hainan Province†was formulated to encourage the establishment of Hainan Province. A unified warehouse for third-party medical device logistics will be used to centralize and standardize the management of the warehouses of some medical equipment with zero-inventory or small-scale, or warehouse-distributed medical device operators. At present, two companies have been approved to carry out third-party logistics and warehousing of medical devices. The last step is to establish a follow-up inspection system. In order to strengthen the supervision and inspection of medical device management companies, a follow-up inspection system has been established. On the basis of the previous stage of renovation and the acceptance of new standards, 100 key companies were selected, and inspections were carried out not less than once a year. The new medical device manufacturers issued a permit for medical device operators. A supervision and inspection will be arranged within 6 months from the date of the permit, and will be included in key inspections of key enterprises during the second year.
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