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　　The Measures for the Rapid Review and Approval of Medical Devices in Beijing have been deliberated and adopted at the 5th Director’s Office Meeting of Beijing Food and Drug Administration in 2018, and are hereby issued, please follow them.

Beijing Food and Drug Administration

February 9, 2018

Measures of Beijing Municipality for the Examination and Approval of Rapid Review of Medical Devices

　　the first　According to the requirements of the Notice of the General Office of the State Council City, the General Office of the Central Committee of the CPC on Printing and Distributing Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Medicines and Medical Devices (Z.Z. [2017] No.42), according to the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of the Registration of Medical Devices, the Measures for the Administration of the Registration of In-vitro Diagnostic Reagents and the Policy Matters of the Food and Drug Administration on Supporting the Supervision and Industry Development of Zhongguancun, In order to encourage innovation, encourage the transformation of scientific and technological achievements, improve the efficiency of examination and approval of medical devices in Beijing, and promote the rapid development of medical device industry in Beijing, these measures are formulated.

　　the second　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for approval of innovative medical devices:

　　(1) Having relevant national and Beijing scientific research projects, and the patents of core technology inventions involved have been made public or authorized.

　　(2) The invention patent of the core technology, which is the first in Beijing, has the leading product technology in China, has great clinical application value and is involved, has been made public or authorized.

　　(3) Patents for core technology inventions produced by key enterprises in Beijing, such as the 100-thousand-cultivation project and the Beijing Biomedical Industry Leap-forward Development Project (G20), have been made public or authorized.

　　(four) included in the national or Beijing major science and technology projects, key research and development plans;

　　Article　For the implementation of innovative medical devices in accordance with the provisions of Article 2 of these Measures, the person in charge shall be responsible, and early intervention, whole-process counseling, priority registration and testing, priority review and approval, priority registration quality system verification and priority production license matters shall be handled. See Annex 1 for the application requirements of innovative medical devices in Beijing.

　　Article 4　According to the application of the enterprise, Beijing Medical Device Technology Evaluation Center provides pre-consulting services for innovative clinical trial schemes of medical devices that meet the requirements of Article 2 of these Measures.

　　Article 5　For innovative medical devices that meet the requirements of Article 2 of these Measures, enterprises may entrust Beijing medical device manufacturing enterprises to produce products, and the medical device production license of the entrusted party shall obtain the corresponding production scope.

　　Article 6　For innovative medical devices, a cross-disciplinary joint evaluation method can be implemented.

　　Article 7　For innovative medical devices in Beijing that have been listed in the first registration cycle, all adverse medical device events of the product shall be reported and a summary report on monitoring, analysis and evaluation of adverse medical device events shall be submitted to the Beijing medical device adverse event monitoring technical institution and the food and drug administration department in the jurisdiction every year.

　　Article 8　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for priority approval of medical devices:

　　(1) It is urgently needed in clinic, and there is no product of the same variety approved for registration in China;

　　(two) the varieties of medical devices belonging to the Beijing medical materials reserve unit and the unique and frequently-occurring diseases of children or disabled people;

　　(3) Diagnosing or treating rare diseases with obvious clinical advantages;

　　(four) for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs;

　　(5) Intelligent rehabilitation apparatus;

　　(six) Beijing innovative medical device products to improve the production process.

　　Article 9　For medical device products that meet the requirements of Article 8 of these Measures, priority shall be given to registration and testing, priority shall be given to review and approval, priority shall be given to the verification of registration quality system, and priority shall be given to the handling of production licensing matters. Please refer to Annex 2 for the application requirements for priority approval of medical devices in Beijing.

　　Article 10　For the change of medical device registration license matters, the specification of product name, product technical requirements, scope of application, etc. does not involve substantial content changes, which can be combined with the renewal of registration.

　　Article 11　If the recommended standards, the guiding principles of registration technology review and the norms of registration technology review change in the renewal registration of medical devices, the enterprise may not change the licensing matters.

　　Article 12　If the specifications and models of medical devices are reduced, they can be handled in accordance with the registration procedures.

　　Article 13　For in vitro diagnostic reagent products, it is not necessary to submit analytical performance evaluation data, risk analysis data related to product changes, product technical requirements, product specifications and label samples by increasing the packaging specifications with different loading quantities (only the loading differences) and adding the changes of licensing items for applicable models with the same degree of automation. The time limit for registration review was shortened to 30 working days.

　　On the basis of strictly implementing the requirements of the quality system, the enterprise completes relevant risk analysis, performance evaluation, design changes, etc., and keeps records for future inspection.

　　Article 14　Those who fail to apply for registration renewal six months before the expiration of the validity period shall be registered for the first time. If the product has not changed, the latest registered clinical data, registration test report and system verification results may be submitted.

　　Article 15　Formulate the technical guidelines for clinical evaluation of medical devices in Beijing, study the comparison methods of similar medical devices, and simplify the clinical evaluation data of the same variety of medical devices.

　　Article 16　Beijing Medical Device Technology Evaluation Center has established a communication mechanism for enterprises to solve the difficult problems encountered by enterprises in the registration and evaluation stage of medical devices.

　　Article 17　Integrate the on-site inspection of the registered quality system verification and the on-site inspection of the production license. In principle, after the on-site inspection of the new product registration quality system verification has passed and the medical device registration certificate has been obtained, the products added to the Medical Device Production License can be exempted from the on-site inspection.

　　Article 18　For enterprises that have obtained production licenses, applying for the registration of Class II medical devices that do not involve new methodology or new technology may be exempted from on-site inspection or optimization of on-site inspection items and processes in the process of registration quality system verification.

　　Article 19　If the contents of the change of medical device registration license items do not involve the change of production process, the on-site inspection may be exempted or the on-site inspection items and processes may be optimized in the process of registration quality system verification.

　　Article 20　For those who have passed the on-site inspection of registered quality system verification at least once in two years, and the products applied for inspection this time have the same or similar working principles and expected uses compared with those that have passed the inspection, and have basically the same structural composition, production conditions and production processes, they are exempted from on-site inspection or optimized on-site inspection items and processes in the process of registered quality system verification.

　　Article 21　If the production address is reduced and the production process changes are not involved, the on-site inspection can be exempted or the on-site inspection items and processes can be optimized during the approval of the production license.

　　Article 22　In principle, on-site re-inspection is not required if no key project defects are found in the on-site inspection of the registered quality system, and the number of general project defects accounts for less than 10% of the total number of general projects that should be inspected.

　　Article 23　If the on-site inspection of the production license requires the enterprise to carry out rectification, the enterprise may be required to submit rectification report and rectification data according to the situation of the on-site inspection and the rectification items, and the on-site re-inspection is not required if it can be verified through the data.

　　Article 24　Optimize the registration examination and approval procedures, and cancel the following examination and review links in the administrative examination and approval of medical device registration:

　　(1) First registration of Class II medical device products (including in-vitro diagnostic reagents) that fully implement the guiding principles of product registration technology review issued by china food and drug administration or the product registration technology review norms issued by Beijing Food and Drug Administration;

　　(two) the second class of medical devices (including in vitro diagnostic reagents) continued registration;

　　(three) the second kind of medical devices (excluding in vitro diagnostic reagents) product description changes;

　　(four) the second kind of medical devices (including in vitro diagnostic reagents) product registration certificate error correction.

　　Article 25　These Measures shall not apply to domestic applicants who apply for approval of innovative medical devices to Beijing Food and Drug Administration according to the Notice of the General Administration of Food and Drug Administration on Printing and Distributing Special Approval Procedures for Innovative Medical Devices (Trial) (No.13 [2014] of the Food and Drug Administration).

　　Article 26　These Measures shall be interpreted by the Beijing Food and Drug Administration.

　　Article 27　These Measures shall come into force as of the date of promulgation. The Measures for the Examination and Approval of Medical Devices in Beijing (Trial) issued on August 11, 2016 (Beijing Food and Drug Administration [2016] No.36) was abolished at the same time.

　　Attachment: 1. Requirements for reporting innovative medical devices in Beijing.

　　 　 　 　2. Requirements for priority examination and approval of medical devices in Beijing

Annex 1

Requirements for reporting innovative medical devices in Beijing

　　In order to standardize the application for innovative medical devices in Beijing and improve the quality of application materials, this application requirement is formulated in accordance with the Measures for the Examination and Approval of Rapid Medical Devices in Beijing.

　　I. Application materials for innovative medical devices in Beijing

　　(a) Beijing innovative medical device review application form (Annex 1)

　　The applicant shall truthfully fill in all the contents.

　　The contents filled in the product performance structure and composition, main working principle/action mechanism and expected use should reflect all the important information of product characteristics, be concise and to the point, use standardized and professional terms, and avoid ambiguity.

　　(2) Relevant information of previous applications for innovative medical device approval (approval) (if applicable)

　　If the product has applied for innovative medical device products from china food and drug administration or Beijing Food and Drug Administration, for the innovative medical devices that have been applied for again, copies of previous notices shall be provided, and explanations on product changes and improvement of application materials shall be submitted.

　　(3) A photocopy of the business license of the enterprise to which it applies.

　　(four) the intellectual property rights of the products and the supporting documents.

　　1. Provide a description of the intellectual property rights of the core technology of the innovative medical device applied for. If there are many invention patents, it is suggested to display the information such as the name of the invention patent, the patentee and the patent status in a list.

　　2. Provide relevant intellectual property documents.

　　(1) If the applicant has obtained the patent right for invention, it is required to provide the original copy of the patent power of attorney, the patent claim, the specification and the copy of the patent register signed by the applicant.

　　(2) If the applicant has obtained the right to use the invention patent in China through the transferee according to law, in addition to submitting the copy of the patent authorization, patent claim, specification and patent register held by the patentee, it is also necessary to provide the original Certificate of Filing the Patent License Contract issued by the patent administrative department.

　　(3) If the application for a patent for invention has been made public by the patent administration department of the State Council and is not authorized, it is necessary to provide a copy of the proof document of the publication of the invention patent signed by the applicant (such as the notice of publication of the application for a patent for invention, the notice of publication of the application for a patent for invention and the notice of entry into the substantive examination stage, etc.) and a copy of the published version of the claim and specification. In the process of examining an application for a patent for invention, if the patent claim and specification are modified at the request of the patent examination department, the modified text shall be submitted; Where the patentee changes, the certifying documents issued by the competent patent department, such as a copy of the notice of conformity, shall be submitted.

　　(V) Summary of product development process and results

　　Summarize the original intention of product research and development, laboratory research, animal experimental research, clinical research and results, and submit a comprehensive report on product research and development including design input, design verification and design output. Information on patient selection criteria, as well as parameters to be monitored and factors to be considered during use.

　　(6) Product technical documents, which shall at least include:

　　1. The intended use of the product;

　　(1) It should be made clear that the treatment and diagnosis expected to be provided by the product conform to the purpose defined in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and the applicable medical stage (such as monitoring and rehabilitation after treatment) can be described;

　　(2) explain whether the product is used once or repeatedly;

　　(3) A description of the equipment expected to be used in combination with it;

　　(4) Information of the target patient population (such as adults, children or newborns).

　　2. Working principle/action mechanism of the product;

　　Elaborate the working principle/mechanism of the product to achieve its expected use, and provide relevant basic research data.

　　3. Make clear the main technical indexes of products and the basis for determination, the index requirements of main raw materials and key components, the main production process and flow chart, and the inspection methods of main technical indexes.

　　(seven) certification documents of product innovation, which shall at least include:

　　1. Novelty retrieval report issued by information or patent retrieval institutions.

　　It should be a sci-tech novelty report issued by information retrieval institutions in China or a novelty report issued by patent retrieval institutions. The contents of the report should be able to prove the innovation point, innovation level and reasons of the product. The novelty retrieval report is valid for one year.

　　2. Summary of academic papers, monographs and documents published in core journals that can fully explain the clinical application value of products (if any)

　　Can provide product literature, but also provide overseas literature of similar products.

　　3. Analysis and comparison of the application of similar products listed at home and abroad.

　　(1) Provide a description of the retrieval of similar products that have been listed in China. Generally, it should include the retrieval database, retrieval date, retrieval keywords and the results retrieved by each keyword, and analyze the differences between the applied innovative medical devices and similar products on the market in terms of working principle/mechanism.

　　(2) Provide an explanation of the application of similar products listed overseas, compare and analyze the similarities and differences with this product, and provide comparative analysis data to support this product to be at the international leading level in technology.

　　4. The innovative content of the product and its remarkable value in clinical application.

　　(1) Overview of innovative medical devices applied for.

　　This paper expounds the innovative contents of the applied medical device, and discusses that the device has been significantly improved in terms of safety, effectiveness and economy compared with the existing products or treatment methods through innovation, and has significant clinical application value.

　　(2) Provide relevant supporting materials.

　　(eight) product safety risk management report.

　　1. Based on the research results of the risk management process carried out by the product.

　　2. Prepared according to YY/T 0316 "Application of Medical Device Risk Management to Medical Devices".

　　(9) Product description (sample draft).

　　It shall comply with the relevant requirements in the Regulations on the Administration of Instructions and Labels of Medical Devices (Order No.6 of the General Administration).

　　(ten) other documents that prove that the product conforms to Article 2 of the Measures for the Examination and Approval of Medical Devices in Beijing.

　　1. If the product or its core technology has won national and Beijing municipal science and technology awards, please explain and submit copies of relevant supporting documents;

　　2. The approval certificate of key supporting enterprises in Beijing, such as the 100 thousand cultivation project and the Beijing biomedical industry leap-forward development project (G20).

　　3 included in the national or Beijing major science and technology projects, key research and development plan documents.

　　(eleven) the self-assurance statement of the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the review of innovative medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous application for examination of innovative medical devices, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for innovative medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall formally review the application materials, and issue a receipt document (Annex 2) within 5 working days; The device will be reviewed by relevant experts within 40 working days, and the applicant and product name will be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties to be included in Beijing’s innovative medical devices. If there is no objection after the publicity period, a final review opinion will be issued, and a notice of review of innovative medical devices in Beijing (Annex 3) will be made to inform the applicant in writing.

　　Attachment: 1. Application Form for Review of Innovative Medical Devices in Beijing

　 　 　 　　2. Beijing Innovative Medical Devices Review Receipt Certificate

　 　 　 　　3. Notice of Review Opinions on Innovative Medical Devices in Beijing

Annex 1 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Annex 2 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Beijing Innovative Medical Device Review Receiving Material Voucher

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Innovative Medical Device Review Receiving Material Voucher

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Notice of Beijing Municipality on Review Opinions of Innovative Medical Devices

　　(No.:_ _ _ _ _)

　　The application for examination of innovative medical devices in Beijing submitted by your company (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

Annex 2

Requirements for Priority Approval and Declaration of Medical Devices in Beijing

　　In order to standardize the application for priority approval of medical devices and improve the quality of application materials, this application requirement is formulated in accordance with the Measures of Beijing Municipality for Rapid Review and Approval of Medical Devices (Revised).

　　First, Beijing gives priority to the examination and approval of medical device application materials.

　　(1) Application Form for Priority Approval of Medical Devices (Annex 1)

　　Clearly explain the circumstances specified in Article 14 of the Measures for the Rapid Review and Approval of Medical Devices in Beijing (Revised), and briefly describe the reasons for priority approval.

　　(two) a copy of the application form for registration of medical devices.

　　(three) in accordance with the "Beijing medical device rapid review and approval measures" eighth cases of medical device priority approval application, should provide information according to the following requirements:

　　1 clinical needs, and there is no product of the same variety approved for registration in China.

　　(1) Summary of the clinical treatment status of the indications of this product, explaining the reasons for urgent clinical need;

　　(2) The overseas approval and clinical use of this product and similar products;

　　(3) Provide a description of the search, which proves that there are no related products of the same variety approved for registration in China at present, and there is no equivalent alternative diagnosis or treatment method at present.

　　2. The medical device reserve varieties belonging to the Beijing medical material reserve unit and the medical device varieties used by children or disabled people with unique and multiple diseases.

　　(1) the certificate of entering the catalogue of medical material reserve units in Beijing;

　　(2) The indication of this product belongs to the supporting data of unique and frequently-occurring diseases of children or disabled people;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description and relevant supporting materials proving that the product is specially used for diagnosing or treating unique and frequently-occurring diseases of children or disabled people, and has obvious clinical advantages compared with existing products or treatment methods.

　　3 diagnosis or treatment of rare diseases, and has obvious clinical advantages.

　　(1) Incidence data of the indications of this product and relevant supporting data;

　　(2) Supporting data to prove that the indication is a rare disease;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description of the obvious clinical advantages of this product compared with the existing products or treatment methods and relevant supporting materials.

　　4 for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs.

　　(1) To prove that the indication belongs to the urgently needed supporting information for treating diseases that are seriously life-threatening and have no effective treatment methods, and public health;

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　5. Intelligent rehabilitation apparatus

　　(1) Medical devices that meet the definition of intelligent rehabilitation devices in the "Thirteenth Five-Year Plan for Scientific and Technological Innovation of Health Industry" (No.149 [2017] of National Science and Technology Development Agency);

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　6. Improve the production process of innovative medical device products in Beijing.

　　(1) Notice of Review Opinions on Innovative Medical Devices in Beijing;

　　(2) Description of production process changes of new and old products.

　　(4) A self-assurance statement on the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the examination and approval of priority medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous priority examination and approval of the medical device application, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for the priority approval of medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall conduct a formal review of the application materials, and issue a receipt document (Annex 2) within 5 working days; The device shall be reviewed by relevant experts within 40 working days, and the applicant and product name shall be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties of medical devices to be approved in Beijing. If there is no objection after the publicity period, a final review opinion will be issued, and a notice (Annex 3) for the review of medical devices with priority approval in Beijing will be made, and the applicant will be informed in writing.

　　Attachment: 1. Application Form for Priority Approval of Medical Devices in Beijing

　 　 　 　　2. Beijing Municipality gives priority to the examination and approval of medical devices, and receives the certificate of materials.

　　 　 　 　3. Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

Annex 1 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Annex 2 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Beijing Municipality gives priority to the examination and approval of medical devices.

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Municipality gives priority to the examination and approval of medical devices.

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

　　(No.:_ _ _ _ _)

　　Your application for the examination of medical devices in Beijing with priority approval (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

Profile picture: Russian President Vladimir Putin

　　　　The British media recently revealed that some powerful people in the Russian government hope that Putin can re-serve as Russian president one year after the end of his presidency in March next year. The analysis believes that Putin’s political achievements during his presidency give him reason to become president again.

　　　　Is expected to serve as president until 2023.

　　　　Russian political "power tycoons" composed of former KGB officials expressed their hope that Putin will serve as president for at least another eight years, and even continue until 2023 if possible. Members of this power group include Igor Xie Xin, deputy director of the President’s Office, and Victor Ivanov, Putin’s senior adviser. These officials believe that once Putin leaves office, they are likely to be "kicked out" of the Kremlin.

　　　　Last week, Putin expressed the possibility of becoming Russian prime minister in the future, which surprised his aides. However, according to the plan of the "power tycoons", Putin will return to the presidency after a short term as prime minister. Because there is a short interval between the second and third terms, this practice is not unconstitutional. Once in the Kremlin again, Putin will be able to continue to legally complete the other two presidential terms.

　　　　A source close to Putin’s office said: "For more than two years, the outside world has always believed that Putin will withdraw from Russian politics after his term ends. But now earth-shaking changes have taken place. " "There is no doubt that Putin now wants to stay in politics, either as prime minister or return to the presidency. Such a move has also been supported by Russian political circles and most people. "

　　　 On October 1, Russian President Vladimir Putin spoke at the Eighth Congress of the United Russia Party held in Moscow. On the same day, Putin said that he would lead the United Russia Party campaign group to participate in the new State Duma (lower house of parliament) election on December 2, but he refused to become a member of the party. Xinhua News Agency/AFP

　　　　Putin may amend the constitution after becoming prime minister

　　　　Russia’s "power tycoon" had hoped to keep Putin as president by amending the constitution, but Putin himself did not agree with this practice. Putin said that he hopes to extend the term of a single president to five or seven years, but he will not amend the constitution during his presidency.

　　　　It is speculated that Putin’s statement implies that he will amend the constitution after becoming prime minister. Theoretically, Putin can serve as president for another 14 years after the constitutional amendment. If this plan is finally realized, Putin will serve as Russian president for 22 years.

　　　　Experts say that even as prime minister, Putin can remain in power, and all he needs to do is to transfer part of the president’s power to the prime minister through parliamentary voting. Zubcov, the new Russian Prime Minister, was previously regarded as a popular candidate for the next president. However, due to the lack of power base, Zubcov is likely to be just a "caretaker" of the government.

　　　　The "Putin era" has just begun

　　　　Nikonov, head of the Russian government think tank, said: "At present, it is only the beginning of the Putin era." The famous Russian political critic Pozner said: "Most Russians hope that Putin will continue to serve as president. They believe that Putin has brought them pride again. "

　　　　During his presidency, Putin has brought great changes to Russia, avoiding the turmoil that occurred in Latin American countries in Russia. For example, in saratov, a small town near Moscow, commerce has gradually begun to be established, and manufacturing industries, including furniture factories, can also meet the daily consumption needs of local residents. These developments have solved the problems that have existed since the Soviet era. In addition, local universities are equipped with the best computers, and agriculture has also improved.

　　　　One of Putin’s most important achievements is that the shadow brought by the Chechen issue has gradually dissipated under the guidance of a series of policies. Some media who "don’t like" Putin also admit that Grozny, the capital of Chechnya, has finally begun the process of reconstruction after 20 years of turmoil. The local tourism in Chechnya is also developing vigorously at present, and the tension caused by Chechen terrorists has become a thing of the past.

　　　　The commentary believes that if the Russian people affirm Putin’s political achievements and Russia is indeed in the process of re-emergence, then Putin, as a successful president, has every reason to extend his term again. (Zhong Long)

Editor: Li Xiuwei

A few days ago, Dongfeng officially announced that its Xiaolong armor model was officially launched, and the new car launched two models, with a guide price of 768,000 yuan and 868,000 yuan respectively. The car is a production version co-branded with the movie "Dragon Action". The new car is equipped with a brand-new roof extension platform and trailer system, and is equipped with an extended range power system.

The appearance of the new car follows the "bold" design concept of the warrior family, with a straight waterfall grille and an engine cover that can be equipped with high-position spotlights. Personalized customization is provided, and many places are made of carbon fiber, with a coverage rate of 22.3%. There is a T-MAX electric winch in the front with a pulling force of 12,500 pounds. Standard desert storm yellow military paint, available in ancient silver, Niger black and Fanjing green. Wide side design, sharp lines, closed rims, carbon fiber side hanging storage box, C window hanging plate, roof expansion platform and transparent fuel tank cover. There is a carbon fiber multifunctional spare tire bracket at the rear of the car, which can be hung for storage.

In terms of interiors, the new car comes standard with a moon shadow gray interior, which has two modified colors: frost white and red orange. Equipped with three screens, Napa leather seats, suede roof, interior wood grain can be changed to carbon fiber. The power is extended range power. The maximum power of the 1.5T engine is 197 HP, the total power of the three motors is 816 HP, the torque is 1050 Nm, and the pure electric battery life is 200km. It is equipped with the world’s first electric drive assembly with integrated differential lock and two-speed gearbox, with electronically controlled differential lock, etc., and supports various off-road modes. The rear wheel angle is 10.6, the turning radius is 5.1 meters, and there are K-MAN coil spring nitrogen reduction, multifunctional rear trailer hook, etc. The maximum traction is 2.5 tons.

Rumors about Xu Jiayin finally settled. On the evening of September 28, China Evergrande issued an announcement saying that the company had received a notice from relevant departments that Xu Jiayin, the executive director and chairperson of the board of directors of the company, had been taken compulsory measures according to law for suspected illegal crimes.

On the morning of the same day, China Evergrande, Hengda Automobile, and Hengda Property, three Hengda companies, announced that the company’s shares had temporarily stopped trading at 9 a.m., and the three Hengda companies had resumed trading shortly thereafter.

The three companies collectively suspended their trading, which made the market speculate that something big might happen to Evergrande. Unexpectedly, the relevant rumors about Xu Jiayin’s situation came true.

Many industry insiders believe that, as the head of Evergrande, Xu Jiayin was forced to take measures, which will affect the progress of the workout.

China Evergrande announced that Xu Jiayin, the executive director and chairperson of the board of directors of the company, has been taken compulsory measures according to law on suspicion of illegal crimes. Photo/IC photo

Lawyers say this could be just the beginning

Since September 23, news of Xu Jiayin’s situation has been circulating in the public. On September 28, China Evergrande, Evergrande Automobile and Evergrande Property suspended trading on the Hong Kong Stock Exchange, which caused many discussions.

Hengda did not respond to the reason why Xu Jiayin was taken coercive measures for suspected crimes.

Wang Yushen, director of Beijing Jinsheng Law Firm, analyzed that from the announcement, Xu Jiayin’s suspected crime has been "real" and coercive measures have been taken. This shows that the public security organs have relatively sufficient evidence of Xu Jiayin’s suspected crime, otherwise they will not take coercive measures against him.

Wang Yuchen further said that in the past, Hengda executives were investigated and now Xu Jiayin has been taken coercive measures, which all shows that Hengda has now entered a period of great crisis. Xu Jiayin’s coercive measures are probably just the beginning, and there may be a series of big moves in the future.

On the evening of September 16, the Nanshan Branch of Shenzhen Public Security Bureau announced that recently, the public security organs have taken criminal compulsory measures against Du and other suspected criminals of Evergrande Financial Wealth Management (Shenzhen) Co., Ltd. If investors need to report the case, they can register the case.

It is understood that on August 31 this year, Hengda Wealth official Weibo announced that because the company’s asset disposal progress was less than expected and no asset disposal funds were obtained, the company was unable to carry out this month’s redemption, and subsequent redemption arrangements will be announced separately.

For the Xu Jiayin incident, in the opinion of Yan Yuejin, Chief Research Officer of E-House Research Institute, the announcement issued by Evergrande this time confirms the fact that Evergrande’s debt problem is not a simple financial and economic dispute, but involves a large financial default and illegal operation. From this perspective alone, the anti-corruption work of real estate enterprises began with the incident of Hengda’s accountability, and other real estate enterprises have no chance of getting lucky.

Evergrande workout or face variables

Xu Jiayin was forced to take measures, the ongoing Hengda workout, or face variables.

Zhang Hongwei, founder of Mirror Consulting, said that without a decision-maker, Evergrande’s workout is expected to be interrupted for a period of time, and things will be delayed. Relevant departments are expected to take measures soon, such as a large enterprise hosting Evergrande.

Wang Yuchen believes that Xu Jiayin’s coercive measures may affect Evergrande’s workout. After all, Xu Jiayin, as the chairperson of Evergrande’s board of directors, has a significant impact on Evergrande’s future direction and the future development of Evergrande.

In fact, before this, Hengda workout has seen bad news.

On September 24, China Evergrande issued an update on overseas workout information, saying that in view of the investigation of Evergrande Real Estate, the current situation cannot meet the eligibility for the issuance of new notes. This means that Evergrande’s workout may face variables.

The announcement shows that all new bills to be issued under the proposed restructuring must comply with the "Trial Measures for the Administration of Overseas Issuance of Securities and Listing of Domestic Enterprises" issued by the China Securities Regulatory Commission and the "Measures for the Administration of the Examination and Registration of Medium and Long-term Foreign Debt of Enterprises" issued by the National Development and Reform Commission according to their applicable circumstances. China Evergrande must prove that it meets the relevant requirements. In view of the above reasons, China Evergrande’s current situation cannot meet the eligibility for the issuance of new bills.

Previously on August 16, Hengda Real Estate announced in the Shenzhen Stock Exchange that it had received the "Notice of Filing" issued by the China Securities Supervision Commission, because the company was suspected of information disclosure violations, according to the "Securities Law of the People’s Republic of China" and the "Administrative Punishment Law of the People’s Republic of China" and other laws and regulations, the China Securities Supervision Commission decided to file a case against Hengda Real Estate.

The issuance of new notes is an important part of China Evergrande’s workout plan. In the March workout plan this year, Evergrande Agreement Arrangement Plan 1 stated that the agreement arrangement creditors can obtain new notes at a conversion ratio of 1:1 of their recoverable amount. The new notes have a term of 10-12 years and will be repaid over time. Under Option 2, the agreement arrangement creditors can choose to convert their recoverable amount into: 5-9 years New Notes to be issued by the company.

In addition, under the Jingcheng Arrangement, creditors will receive five new notes issued by Jingcheng with a term of 4-8 years for a total principal amount of $6.50 billion. Under the Space-based Arrangement, creditors will receive four new notes issued by Space-based with a term of 5-8 years for a total principal amount of $800 million.

In addition to the blockage of new note issuance, China Evergrande’s overseas workout-related meetings have also been postponed again. According to China Evergrande’s announcement released on September 22, China Evergrande’s sales since March 22 this year have not been as expected. Based on the current situation of China Evergrande and its consultations with its advisors and creditors, China Evergrande believes that it is necessary to re-examine the terms of the proposed restructuring to match its objective situation and creditors’ demands. Therefore, the relevant agreement and arrangement meetings on the proposed restructuring originally scheduled for September 25 and September 26 will not be held. This is the third postponement.

The market is also concerned about whether Xu Jiayin’s coercive measures will affect "Baojiaolou"? Wang Yuchen said that Evergrande has many subsidiaries all over the country, and each company is relatively independent. Therefore, for buyers who bought Hengda houses but encountered unfinished business, as well as investors who invested in Evergrande, they need to pay close attention to the next direction of Evergrande, but do not worry too much. Now that the state has taken action, and the "Baojiaolou" involving so many ordinary people, there should eventually be a corresponding solution.

Duan Wenping, reporter of Beijing News

Editor, Yang Juanjuan, Proofreader, Yang Xuli

　　On August 18th, Jinan Hi-tech wanda plaza was full of people. On this cool summer day, the launch conference of BYD Hanbei region Jinan stood here as scheduled. As the flagship model of BYD Dynasty series, Hanhan attracted attention from all walks of life at the beginning of its listing. This event is the first listing conference of Han in Shandong, and well-known local media have come to participate.

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