One、The overall situation has been comprehensively analyzed，The top 10 prefectures and cities in the comprehensive evaluation of occupational health supervision in the first half of the province are：Guangzhou、Foshan、Shenzhen、Zhuhai、Dongguan、Zhongshan、Jiangmen、Maoming、Huizhou、Meizhou。The details of each evaluation project are as follows： (A) administrative supervision and law enforcement。Half，A total of 1,582 cases were filed and punished in the province，The economic penalty was 30,472,833 yuan，respectively year-on-year (compared to the first half of 2017，the same below) increased by 48.27% and 33.72%；565 employers were suspended for rectification，An increase of 100.35% year-on-year；660 employers were requested to be closed，An increase of 183.26% year-on-year。 (2) Declaration of occupational disease hazards。As of the end of June 2018，A total of 162648 enterprises in the province have completed the online declaration of occupational disease hazard projects，Year-on-year increase of 6.07%，Declaration coverage rate 44.47%；In the first half of the year, 11,261 new online declaration enterprises were added，Year-on-year decrease of 5.73%。 (3) The "three simultaneities" of occupational disease prevention facilities and the evaluation of the current situation。Half，The province has completed a total of 595 "three simultaneous" construction projects of occupational disease prevention facilities，An increase of 3.48% year-on-year；587 evaluations of the current status of occupational disease hazards were completed，A year-on-year decrease of 10.93%；15 cases of "three simultaneities" were filed and punished for occupational disease prevention facilities，Year-on-year decrease of 21.05%。 (4) Occupational health monitoring。Half，A total of 1363215 workers have undergone occupational health examinations in the province，Year-on-year increase of 43.37%；A total of 43,122 enterprises have conducted occupational health examinations，An increase of 30.72% year-on-year。 (5) Occupational health management of employers in key industries。In the first half of the year, the results of the survey in various parts of the province showed，Non-coal mines in the province、Hazardous chemicals、There are 24,913 occupational health management enterprises in 23 key industries in metallurgy and other industries。thereinto，The declaration rate of occupational disease hazards was 97.32%，The rate of regular detection of occupational disease hazards was 62.55%，75.73% of workers exposed to occupational disease hazards had occupational health examinations during their employment，The main person in charge、The occupational health training rate of occupational health managers was 90.21%。 Two、Highlight the point 1、Shenzhen is manufactured by electronics、electroplate、printing、Stone processing and other industries are the focus of law enforcement，In the first half of the year, a total of 439 cases were filed and punished，The economic penalty was 8,551,583 yuan；In the past three years, Foshan City has classified and graded D-level enterprises for occupational safety and health as the key law enforcement targets，In the first half of the year, a total of 294 cases were filed and punished，The economic penalty was 4.8365 million yuan；Guangzhou Municipality Formulates List of Key Points of Occupational Health Administrative Inspection for Employers，Improve the institutionalization of regulatory enforcement、Standardization construction，In the first half of the year, 213 cases were filed and punished，The economic penalty is 4,254,450 yuan；Dongguan City carried out a verification action on the handling of suspected occupational disease patients，A total of 364 suspected occupational diseases were verified，264 employers were involved，8 companies were punished，The financial penalty is 448,000。Jiangmen City has launched a special action to supervise the law enforcement of protective equipment for occupational diseases，1,650 employers were inspected，5 companies were punished，Warning 2 homes，A fine of 165,000 yuan was imposed，1 company was suspended for rectification。 2、Standardize the conduct of occupational health technical services。Foshan City held a working meeting on occupational health technical service institutions，Report on the supervision and inspection of technical services in 2017，Interviews with the heads of 11 non-compliant agencies、Yellow card warnings were issued to 3 institutions，2 institutions were investigated and punished，A total fine of 10,000 yuan was imposed。Zhongshan City combines the annual occupational health technical service quality spot check and online supervision platform，Continuously strengthen the supervision of occupational health technical service institutions，In the first half of the year, five institutions were admonished and interviewed，and fined Guangdong Huasheng Safety Occupational Evaluation Co., Ltd. 144,000 yuan for violations of occupational health technical services。Zhuhai has strengthened the supervision and inspection of occupational health technical service institutions，In the first half of the year, 2 institutions were investigated and punished，A total fine of 10,000 yuan was imposed。 3、The incidence of occupational diseases in the province is still high。Our province has a large economic aggregate，There are many enterprises with occupational disease hazards，The number of patients with potential occupational diseases is large，The incidence of occupational diseases is still high。In the first half of this year, the total number of new occupational diseases in the province increased by nearly 40% compared with the same period last year，The situation of occupational disease prevention and control is still grim。 The main responsibilities of some employers are not in place。It was found in the recent supervision and inspection work of the province，Employers in some key industries and fields have a weak awareness of the rule of law，Investment in the prevention and treatment of occupational diseases is seriously insufficient，The responsibility for the prevention and treatment of occupational diseases is not in place，The archives system is not perfect，Occupational health monitoring work is not standardized，There are many hidden dangers of occupational diseases。 Occupational health law enforcement and supervision need to be further strengthened。Shantou、Zhanjiang、Huizhou、Qingyuan、In the first half of the year, the amount of economic penalties for occupational health in five cities, including Meizhou, decreased by more than 20% year-on-year。Individual prefectures and cities failed to promptly report information and cases on law enforcement activities as required。Some supervisors and inspectors do not have enough knowledge of occupational health law enforcement，The operational capacity of law enforcement and supervision needs to be improved。 ...

recently，The "Shanghai Municipal Measures for the Administration of Classified Supervision" has been officially released，Creation of "Classification Supervision Evaluation Index"。Categorical regulatory evaluation indicators should be designed in accordance with the principle of regulatory orientation,It reflects the compliance of the supervised object with the law and the fulfillment of contractual obligations,It covers the regulatory functions of the supervisory authority itself,Ensure that the department performs its duties and responsibilities。 ...

The Shanghai Municipal Food and Drug Administration has issued a notice on the storage of medical devices、Notice of special inspection carried out by distribution service enterprises Certification and Evaluation Center of the Municipal Food and Drug Administration、Law Enforcement Corps of the Municipal Food and Drug Administration、Market Supervision Bureaus of all districts： In order to further strengthen the city's provision of storage for other medical device production and operation enterprises、Supervision of distribution service enterprises (hereinafter referred to as "third-party logistics enterprises").，Implement the main responsibility of enterprises，Supervise and urge the city's medical device tripartite logistics enterprises to carry out medical device storage in accordance with the requirements of the "Implementation Rules for the Quality Management Standards of Medical Device Operation in Shanghai".、Delivery services，In accordance with the "2018 Shanghai Medical Device Supervision Work Plan".，Combined with the actual supervision of the city，The special inspection plan is hereby formulated as follows： One、Inspection object: Obtain the "Medical Device Business License" before the end of 2017，And the business scope of the license includes "providing storage for other medical device production and operation enterprises."、distribution services".，31 in total，So far, 2 have failed to renew their permits on time，Expiration of the original license (Annex 1)。 Two、Inspection content According to the "Medical Device Business Quality Management Standards" and "Medical Device Cold Chain (Transportation、Storage) management guide" and "Shanghai Medical Device Operation Quality Management Standards Implementation Rules" in the relevant requirements，Focus on whether the actual storage and transportation situation of the tripartite logistics enterprise is consistent with the permitted items，Whether it is in accordance with the medical device product label、Labeling requires the product to be stored、transport，Whether the real-time regulatory information platform provided to the regulatory authorities is true and consistent with reality，Enterprises carry out self-inspection and verification of the implementation of GSP such as the implementation of rectification and rectification，For details of the specific inspection of this special project, please refer to the "2018 Special Inspection Form" (Annex 2)。 The criterion for judging the inspection conclusion is that all the inspection items meet the requirements as "passing the inspection"，If more than one inspection item (including one) does not meet the requirements, it is "rectification within a time limit"，The on-site inspection is suspected of violating laws and regulations and requires further investigation，After fixing the evidence at the scene，Promptly file a case for handling。 Three、Inspection arrangements (1) Inspection time: August 1, 2018 - October 31, 2018 (2) Division of work The Drug and Medical Device Circulation Supervision Department of the Municipal Food and Drug Administration is responsible for formulating the overall plan，Determine the list of companies to be inspected，Be clear about inspection requirements，Develop an on-site checklist，Disclosure of information on the results of supervision and inspection, and coordination of related work during the inspection。 The Certification and Evaluation Center of the Municipal Food and Drug Administration is responsible for organizing the inspection，Combined with daily permit check arrangements，Make an inspection plan，According to the number of corporate warehouses、The size of the enterprise is reasonably arranged for the inspection time，Summarize the inspection results and special summaries。 The law enforcement team of the Municipal Food and Drug Administration sent personnel to participate in the inspection，Serve as the inspection team leader according to the inspection arrangement。Conduct audits around the legitimacy of the enterprise，Detection of violations，Promptly file a case for handling。 The District Market Supervision Bureau sends personnel to participate in the inspection of enterprises within its jurisdiction。 (3) Composition of inspectors The inspection team is certified and evaluated by the Municipal Food and Drug Administration、Law Enforcement Corps of the Municipal Food and Drug Administration、The market supervision bureau of the district where the enterprise is located shall be composed of 1 person each，The Pharmaceutical and Medical Device Circulation Supervision Department of the Municipal Food and Drug Administration sent personnel to participate in the work arrangement。 The Certification and Evaluation Center of the Municipal Food and Drug Administration shall arrange according to the inspection，Notify the law enforcement team of the municipal bureau and the market supervision bureau where the enterprise is located one week in advance，And the inspection arrangements will be copied to the Municipal Bureau of Medicine and Equipment Circulation。 Four、Inspection requirements (1) Implement the team leader responsibility system。The team leader should do a good job of checking the division of labor and task arrangement，Conscientiously check one by one in accordance with the content of this special inspection，Record and photograph the non-conformities found at the scene，Make copies of relevant documents，Record the inspection site situation、issues found, etc，And it is signed and confirmed by the inspected enterprise。The inspection results are entered into the post-certificate supervision system of our bureau in a timely manner，The inspection form shall be sent to the Drug and Medical Device Circulation Department of the Municipal Food and Drug Administration within one week after the end of the inspection。 (2) Timely disposal of inspection results。It is necessary to rectify within a time limit，It should be immediately reported to the Drug and Drug Circulation Supervision Department of the Municipal Food and Drug Administration；Suspected of violating laws and regulations，The case will be investigated by the Law Enforcement Corps，Dispose of it in accordance with the law。 (3) Supervise and urge enterprises to rectify in place。Defects found during the inspection，The Municipal Food and Drug Administration's Drug and Medical Device Circulation Supervision Department issued a "Notice of Rectification within a Time Limit" to the enterprise，The enterprise shall submit a rectification report to the inspection team within 7 days，And complete the rectification within a time limit。 (4) Strictly abide by the discipline of clean government。In the supervision and inspection，The inspection team should administer in strict accordance with the law。Check Chinese law enforcement，Corporate catering banquets and vehicle transfers are not accepted，It is forbidden to take the opportunity of the inspection to accept gifts and gifts from the inspected unit。 Notice is hereby given。 annex： 1.List of third-party logistics enterprises for medical devices in Shanghai (as of the end of 2017) 2. Storage of medical devices in Shanghai in 2018、Special Checklist for Distribution Service Enterprises Shanghai Food and Drug Administration July 24, 2018 (Contact：Chen Wei, Department of Drug and Medical Device Circulation Supervision Tel：23118222Visibility (Scope.)：Voluntary disclosure) ...