Notice regarding the submission of demand for orthopedic trauma medical consumables from 12 provinces (regions, municipalities)

Notice on Reporting the Demand for Orthopedic Trauma Medical Consumables in Twelve Provinces (Regions and Municipalities) To all provincial and municipal medical insurance bureaus, medical institutions directly administered by the province in Zhengzhou, and Jiyuan Demonstration Zone: To ensure the smooth progress of the alliance procurement of orthopedic trauma medical consumables in twelve provinces (regions and municipalities), and according to the work arrangement, this notice is issued regarding the reporting of the demand for orthopedic trauma medical consumables. I. Scope of Institutions All public medical institutions and military medical institutions stationed in Henan Province should participate. Designated social medical institutions are welcome to participate voluntarily. II. Scope of Products to be Reported Bone plates and matching screws, intramedullary nails and accessories, hollow screws, etc. Bone plates and matching screws constitute a system, intramedullary nails and their accessories constitute a system. There are three procurement packages in total: ordinary bone plate system, locking compression bone plate system, and intramedullary nail system. III. Reporting Method and Time This reporting work will be carried out through a unified platform and centralized data submission. Within the open time of the reporting system, relevant medical institutions should log in to the "Twelve Provinces (Regions and Municipalities) Orthopedic Trauma Medical Consumables Hospital Demand Reporting System (http://hc.tjmpc.cn:14206/) using the account and password of the "National Organization of Medical Consumables Joint Procurement Platform." Under the corresponding directory, referring to the historical procurement data of 2019 and 2020, and based on actual clinical needs, according to the product list supplied by the enterprise, report the estimated demand for the next year. Specific operation methods can be found in the "Twelve Provinces (Regions and Municipalities) Orthopedic Trauma Medical Consumables Operation Manual" (Attachment). All levels of medical insurance departments should refer to the historical procurement data of medical institutions in 2020 and conduct audits of the reported data. System trial operation time: June 20, 2021. System opening time: June 21, 2021, 0:00—July 3, 2021, 24:00. Medical insurance department audit time: June 30, 2021, 0:00—July 3, 2021, 24:00. IV. Work Requirements (1) Demand reporting is an important basic work for centralized procurement. All levels of medical insurance departments should attach great importance to this data reporting work, and according to the principle of local management, achieve full coverage, promptly notify relevant medical institutions, and urge medical institutions to report relevant consumable procurement data truthfully and within the deadline according to unified requirements. (2) Each medical institution shall be responsible for the authenticity of the reported data. Medical institutions without procurement needs should report the estimated demand as "0". (3) After the system opening time, no supplementary reports or modifications will be accepted. June 17, 2021

May Day, Labor Day! Labor is glorious!

Now Hiring!!!

Now Hiring!!!

Regulations on the Supervision and Administration of Medical Devices

Regulations on the Supervision and Administration of Medical Devices Order of the State Council of the People’s Republic of China No. 739 The Regulations on the Supervision and Administration of Medical Devices, as revised and adopted at the 119th executive meeting of the State Council on December 21, 2020, are hereby promulgated and shall come into force on June 1, 2021. Premier Li Keqiang February 9, 2021 Regulations on the Supervision and Administration of Medical Devices (Promulgated by Order No. 276 of the State Council of the People’s Republic of China on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; revised in accordance with the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices of May 4, 2017; revised and adopted at the 119th executive meeting of the State Council on December 21, 2020) Chapter 1 General Provisions Article 1 These Regulations are formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry. Article 2 These Regulations shall apply to the research, production, operation, and use of medical devices within the territory of the People’s Republic of China, as well as their supervision and administration. Article 3 The State Council’s drug supervision and administration department shall be responsible for the national supervision and administration of medical devices. Relevant departments under the State Council shall be responsible for the supervision and administration related to medical devices within their respective responsibilities. Article 4 County-level and above local people’s governments shall strengthen the leadership of the supervision and administration of medical devices within their administrative regions, organize and coordinate the supervision and administration of medical devices and emergency response work within their administrative regions, strengthen the capacity building for the supervision and administration of medical devices, and provide guarantees for medical device safety work. The departments responsible for drug supervision and administration of county-level and above local people’s governments shall be responsible for the supervision and administration of medical devices within their administrative regions. Relevant departments of county-level and above local people’s governments shall be responsible for the supervision and administration related to medical devices within their respective responsibilities. Article 5 The supervision and administration of medical devices shall follow the principles of risk management, full process control, scientific supervision, and social governance. Article 6 The State shall implement classified management of medical devices according to the level of risk. Class I medical devices are those with low risk levels, whose safety and effectiveness can be ensured through routine management. Class II medical devices are those with moderate risk levels, which require strict control management to ensure their safety and effectiveness. Class III medical devices are those with high risk levels, which require special measures and strict control management to ensure their safety and effectiveness. In evaluating the risk level of medical devices, factors such as the intended purpose, structural characteristics, and methods of use of the medical devices should be considered. The State Council’s drug supervision and administration department shall be responsible for formulating the classification rules and catalogue of medical devices, and shall, based on the production, operation, and use of medical devices, timely analyze and evaluate changes in the risks of medical devices, and adjust the classification rules and catalogue. In formulating and adjusting the classification rules and catalogue, the opinions of medical device registrants, filers, production and operation enterprises, as well as users, industry organizations, should be fully solicited, and international medical device classification practices should be referenced. The classification rules and catalogue of medical devices shall be made public. Article 7 Medical device products shall comply with mandatory national standards for medical devices; in the absence of mandatory national standards, they shall comply with mandatory industry standards for medical devices. Article 8 The State shall formulate medical device industry plans and policies, include medical device innovation in development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The State Council’s drug supervision and administration department shall, in coordination with relevant departments under the State Council, implement national medical device industry plans and guiding policies. Article 9 The State shall improve the medical device innovation system, support basic and applied research on medical devices, promote the promotion and application of new medical device technologies, and provide support in terms of scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. Support enterprises in establishing or jointly establishing research and development institutions, encourage enterprises to cooperate with universities, scientific research institutions, and medical institutions to conduct research and innovation on medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation capabilities of medical devices. Article 10 The State shall strengthen the informatization construction of medical device supervision and administration, improve the level of online government services, and provide convenience for medical device administrative licenses and filings. Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credit system, urge enterprises to conduct production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy. Article 12 Units and individuals who have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations. Chapter 2 Registration and Filing of Medical Device Products Article 13 Class I medical devices shall be subject to product filing management, while Class II and Class III medical devices shall be subject to product registration management. Medical device registrants and filers shall strengthen the quality management of the entire life cycle of medical devices and shall bear legal responsibility for the safety and effectiveness of medical devices throughout the research, production, operation, and use process. Article 14 The following materials shall be submitted for the filing of Class I medical device products and the application for registration of Class II and Class III medical device products: (1) Product risk analysis materials; (2) Product technical requirements; (3) Product inspection report; (4) Clinical evaluation materials; (5) Product instructions and label drafts; (6) Quality management system documents related to product research and development and production; (7) Other materials necessary to prove the safety and effectiveness of the product. The product inspection report shall comply with the requirements of the State Council’s drug supervision and administration department, and may be a self-inspection report of the medical device registrant or filer, or an inspection report issued by a qualified medical device inspection institution. Clinical evaluation materials may be exempted from submission if they meet the conditions for exemption from clinical evaluation as stipulated in Article 24 of these Regulations. Medical device registrants and filers shall ensure that the submitted materials are legal, true, accurate, complete, and traceable. Article 15 For the filing of Class I medical device products, the filer shall submit the filing materials to the department responsible for drug supervision and administration of the municipal people’s government where it is located. For overseas filers exporting Class I medical devices to China, the enterprise legal person designated by the overseas filer shall submit the filing materials and the proof document issued by the competent authority of the filer’s country (region) permitting the medical device to be marketed to the State Council’s drug supervision and administration department. Innovative medical devices that have not been marketed overseas may not submit the proof document issued by the competent authority of the filer’s country (region) permitting the medical device to be marketed. The filer shall complete the filing upon submitting the filing materials that comply with the provisions of these Regulations to the department responsible for drug supervision and administration. The department responsible for drug supervision and administration shall, within 5 working days from the date of receipt of the filing materials, publish the relevant filing information to the public through the online government service platform of the State Council’s drug supervision and administration department. If the matters stated in the filing materials change, the original filing department shall be notified of the change. Article 16 For the application for registration of Class II medical device products, the applicant shall submit the registration application materials to the drug supervision and administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where it is located. For the application for registration of Class III medical device products, the applicant shall submit the registration application materials to the State Council’s drug supervision and administration department. For overseas applicants exporting Class II and Class III medical devices to China, the enterprise legal person designated by the overseas applicant shall submit the registration application materials and the proof document issued by the competent authority of the applicant’s country (region) permitting the medical device to be marketed to the State Council’s drug supervision and administration department. Innovative medical devices that have not been marketed overseas may not submit the proof document issued by the competent authority of the applicant’s country (region) permitting the medical device to be marketed. The State Council’s drug supervision and administration department shall formulate regulations on the medical device registration review procedures and requirements, and strengthen the supervision and guidance of the registration review work of the drug supervision and administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government. Article 17 The drug supervision and administration department that accepts the registration application shall review the safety and effectiveness of the medical device and the quality management capabilities of the applicant to ensure the safety and effectiveness of the medical device. The drug supervision and administration department that accepts the registration application shall, within 3 working days from the date of acceptance of the registration application, transfer the registration application materials to the technical review institution. The technical review institution shall, after completing the technical review, submit the review opinions to the drug supervision and administration department that accepts the registration application as the basis for approval. If the drug supervision and administration department that accepts the registration application deems it necessary to verify the quality management system when organizing the technical review of the medical device, it shall organize a quality management system verification. Article 18 The drug supervision and administration department that accepts the registration application shall make a decision within 20 working days from the date of receipt of the review opinions. For those that meet the conditions, registration shall be granted and a medical device registration certificate shall be issued; for those that do not meet the conditions, registration shall not be granted and the reasons shall be stated in writing. The drug supervision and administration department that accepts the registration application shall, within 5 working days from the date of granting registration of the medical device, publish the relevant registration information to the public through the online government service platform of the State Council’s drug supervision and administration department. Article 19 For medical devices used to treat rare diseases, diseases that seriously endanger life and for which there are no effective treatment methods, and urgently needed medical devices for dealing with public health events, the drug supervision and administration department that accepts the registration application may make a conditional approval decision and state the relevant matters in the medical device registration certificate. In the event of a particularly serious public health emergency or other emergency that seriously threatens public health, the State Council’s health authority may, based on the needs of preventing and controlling the event, propose a suggestion for the emergency use of medical devices, which may be used urgently within a certain scope and period after being reviewed and approved by the State Council’s drug supervision and administration department. Article 20 Medical device registrants and filers shall fulfill the following obligations: (1) Establish and maintain the effective operation of a quality management system suitable for the product; (2) Formulate and ensure the effective implementation of post-market research and risk control plans; (3) Conduct adverse event monitoring and re-evaluation in accordance with the law; (4) Establish and implement product traceability and recall systems; (5) Other obligations prescribed by the State Council’s drug supervision and administration department. The enterprise legal person designated by the overseas medical device registrant or filer shall assist the registrant or filer in fulfilling the obligations prescribed in the preceding paragraph. Article 21 For registered Class II and Class III medical device products, if there are substantial changes in their design, raw materials, production processes, scope of application, methods of use, etc., which may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for changes to the registration procedures; for other changes, the provisions of the State Council’s drug supervision and administration department shall be followed for filing or reporting. Article 22 The validity period of a medical device registration certificate is 5 years. If registration needs to be renewed upon expiry, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiry of the validity period. Except for the circumstances stipulated in paragraph 3 of this Article, the drug supervision and administration department that receives the application for renewal of registration shall make a decision to grant the renewal before the expiry of the validity period of the medical device registration certificate. If no decision is made before the expiry, it shall be deemed as granted. Registration shall not be renewed under any of the following circumstances: (1) Failure to submit an application for renewal of registration within the prescribed time limit; (2) Mandatory standards for medical devices have been revised, and the medical device applying for renewal of registration cannot meet the new requirements; (3) For conditionally approved medical devices, the matters stated in the medical device registration certificate have not been completed within the prescribed time limit. Article 23 For newly developed medical devices that are not yet included in the classification catalogue, the applicant may directly apply for product registration in accordance with the relevant provisions of these Regulations on the registration of Class III medical device products, or may determine the product category according to the classification rules and apply to the State Council’s drug supervision and administration department for category confirmation, and then apply for product registration or filing in accordance with the provisions of these Regulations. For direct applications for registration of Class III medical device products, the State Council’s drug supervision and administration department shall determine the category according to the risk level and promptly include the registered medical devices in the classification catalogue. For applications for category confirmation, the State Council’s drug supervision and administration department shall determine the category of the medical device within 20 working days from the date of receipt of the application and inform the applicant. Article 24 Clinical evaluation shall be conducted for the registration and filing of medical device products; however, clinical evaluation may be exempted under any of the following circumstances: (1) The working mechanism is clear, the design is finalized, the production process is mature, the same type of medical device has been on the market for many years with no record of serious adverse events, and the conventional use is not changed; (2) Other non-clinical evaluations can prove the safety and effectiveness of the medical device. The State Council’s drug supervision and administration department shall formulate guidelines for clinical evaluation of medical devices. Article 25 For clinical evaluation of medical devices, based on product characteristics, clinical risks, and existing clinical data, the safety and effectiveness of medical devices can be demonstrated by conducting clinical trials, or by analyzing and evaluating clinical literature and data of the same type of medical devices. In accordance with the regulations of the State Council’s drug supervision and administration department, clinical trials shall be conducted for medical devices whose existing clinical literature and data are insufficient to confirm the safety and effectiveness of the product. Article 26 Clinical trials of medical devices shall be conducted in clinical trial institutions with the corresponding conditions in accordance with the requirements of the quality management specifications for medical device clinical trials, and shall be filed with the drug supervision and administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial applicant is located. The drug supervision and administration department that accepts the filing of clinical trials shall inform the drug supervision and administration department and health authority at the same level where the clinical trial institution is located of the filing situation. Medical device clinical trial institutions shall be subject to filing management. The conditions that medical device clinical trial institutions should meet, as well as the filing management methods and quality management specifications for clinical trials, shall be formulated and published by the State Council’s drug supervision and administration department in conjunction with the State Council’s health authority. The State supports medical institutions in conducting clinical trials, incorporates the evaluation of clinical trial conditions and capabilities into the grading assessment of medical institutions, and encourages medical institutions to conduct clinical trials of innovative medical devices. Article 27 Clinical trials of Class III medical devices that pose a high risk to humans shall be approved by the State Council’s drug supervision and administration department. When approving clinical trials, the State Council’s drug supervision and administration department shall conduct a comprehensive analysis of the conditions of the institutions that will undertake the medical device clinical trials, such as equipment and professional personnel, the risk level of the medical device, the clinical trial implementation plan, and the clinical benefit-risk comparison analysis report, and shall make a decision within 60 working days from the date of receipt of the application and notify the clinical trial applicant. If no notification is given before the expiry, it shall be deemed as consent. If the clinical trial is approved, the drug supervision and administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located shall be informed.

Kangsheng Jiutai wishes every woman a happy Women's Day!

She is as pretty as a peach in spring, and as pure as a chrysanthemum in autumn.

The price of coronary balloon angioplasty used for myocardial infarction patients has dropped significantly. The first patient to benefit saved nearly 20,000 yuan.

In the early morning of March 1st, the emergency department of Zhengzhou Central Hospital admitted a 56-year-old patient with chest pain.

Kangsheng Jiutai wishes everyone a happy Lantern Festival!

One month after a heart stent costing a few hundred yuan was placed, those expected and unexpected outcomes.

At Qian Mu's hospital, an angiography costs 2000 yuan, but only 150 yuan in the department.

Henan Province's first centralized volume procurement of medical consumables successfully opened bids, with an average price reduction of 66.5%

To implement the guiding principles of the Opinions of the Central Committee of the Communist Party of China.