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Looking for a path of reform and innovation in the medical device industry

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  • Time of issue:2017-11-18
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(Summary description)If it is said that the"Opinions on Reforming the Review and Approval System for Drugs and Medical Devices"has opened the curtain for the reform of review and approval of drugs and medical devices,then the"Regarding the Encouragement of Deepening the Reform of the Review and Approval System"issued by the"Two Offices"recently"Opinions on Innovation of Pharmaceutical and Medical Devices"will further promote the structural adjustment and technological innovation of the pharmaceutical and medical devices industry.

Looking for a path of reform and innovation in the medical device industry

(Summary description)If it is said that the"Opinions on Reforming the Review and Approval System for Drugs and Medical Devices"has opened the curtain for the reform of review and approval of drugs and medical devices,then the"Regarding the Encouragement of Deepening the Reform of the Review and Approval System"issued by the"Two Offices"recently"Opinions on Innovation of Pharmaceutical and Medical Devices"will further promote the structural adjustment and technological innovation of the pharmaceutical and medical devices industry.

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2017-11-18
  • Views:0
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  If it is said that the"Opinions on Reforming the Review and Approval System for Drugs and Medical Devices"has opened the curtain for the reform of review and approval of drugs and medical devices,then the"Regarding the Encouragement of Deepening the Reform of the Review and Approval System"issued by the"Two Offices"recently"Opinions on Innovation of Pharmaceutical and Medical Devices"will further promote the structural adjustment and technological innovation of the pharmaceutical and medical devices industry.


  In the past two years,with the introduction of a series of reform policies,the review and approval standards and transparency have been continuously improved,the ecological environment of R&D registration has been effectively purified,a batch of innovative drugs and medical devices have been approved for listing first,the backlog of drug reviews has been basically resolved,and generic drugs The quality and efficacy consistency evaluation work continues to advance,the basic work of medical device classification has been consolidated,and the pilot work of the drug marketing authorization holder system is progressing smoothly...However,the deeper the reform,the more deep-seated contradictions will be encountered.Looking back on the past and looking to the future,how will the reform of the medical device review and approval system advance?How should enterprises seize development opportunities?On November 8,at the medical device summit seminar held during the 29th National Medical Economic Information Conference,experts spoke freely.


  Six key points of regulatory reform after the listing of medical devices


  Kong Fanpu Director of the Medical Device Supervision Department of the State Food and Drug Administration


  Kong Fanpu,Director of the Medical Device Supervision Department of the State Food and Drug Administration,introduced at the meeting the"Opinions on Deepening the Reform of the Review and Approval System and Encouraging Drug and Medical Device Innovation"(hereinafter referred to as the"Opinions")issued by the"Two Offices"in early October.The State Food and Drug Administration will establish a system for direct reporting of adverse events by marketing license holders,improve the re-evaluation system for medical devices,implement inspection responsibilities throughout the entire process,and establish a team of professional inspectors,etc.,To deepen the post-marketing regulatory reform of medical devices from six aspects:improving the regulatory system after listing,direct reporting of adverse events,re-evaluation system,implementation of full-process inspection responsibilities,building professional inspectors,and strengthening supervision and management of import agents.


  Elevate medical device supervision to the legal level


  Kong Fanpu pointed out that in terms of improving post-marketing regulatory regulations,the long-term task is to summarize experience,incorporate core content into the scope of the revision of the"Drug Administration Law",add a special chapter"Special Provisions for Medical Devices",and strive to raise the regulatory level of medical devices to the legal level,Strengthen the authority of supervision and intensify the crackdown on illegal medical devices.The immediate task is to implement the"Opinions",amend the"Regulations on the Supervision and Administration of Medical Devices,"and amend and improve supporting regulations and normative documents.Including the revision of the"Regulations on the Supervision and Administration of Medical Devices",the formulation and revision of the"Measures for the Supervision and Administration of Medical Device Network Operations",the"Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events",and the"Measures for the Supervision and Administration of Medical Device Production".


  Implement the main responsibility of the registrant or filing person


  In terms of improving the system for registrants or filing parties to directly report adverse events,Kong Fanpu said that the"Medical Device Adverse Event Monitoring and Re-evaluation Management Measures"that is being revised will focus on the implementation of the registrant or filing party’s main responsibility and focus on solving registrants or filing Provisions are made on issues such as what responsibilities a person should perform,how to implement responsibilities,and penalties for violations of regulations.


  Including:The main body responsible for controlling product risks should take the initiative to carry out the monitoring of adverse events of medical devices.It should be equipped with monitoring institutions and personnel commensurate with its products and scale,and actively carry out adverse event monitoring for its products.After receiving the adverse event report,it shall conduct investigation,analysis,and evaluation,and report the evaluation results in time to actively control product risks.Those who fail to carry out adverse event monitoring or report adverse events in accordance with the requirements and fail to cooperate with the work may be given a warning,fine,and ordered to suspend production and business,until the original issuing authority revokes the medical device production license and medical device business license.


  Improve and revise the re-evaluation system for medical devices


  Regarding the improvement of the medical device re-evaluation system,Kong Fanpu revealed that the"Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events"that is being revised will stipulate that the re-evaluation can be initiated by the registrant or filing person,or by the food and drug regulatory authority.The registrant or the filing person shall be ordered to carry out,or organized by the food and drug regulatory authority,and the registrant or filing person shall be the main initiative to implement the main responsibility of the enterprise.If the result of the re-evaluation shows that there is a defect that endangers personal safety that cannot be eliminated or controlled,or the risk-benefit ratio is unacceptable,the registrant or recorder shall take the initiative to apply for cancellation of the marketing license and announce it to the public in a timely manner.If the registrant or filing person should file an application for cancellation but not,the original registration or filing department shall make a decision to cancel the registration certificate or cancel the filing.


  Implement inspection responsibilities according to power


  Regarding how to implement inspection responsibilities throughout the entire process,Kong Fanpu introduced that in terms of the division of inspection powers,the General Administration will strengthen on-site inspections of overseas enterprises and carry out unannounced inspections of domestic production enterprises.The provincial bureau will strengthen the supervision of production enterprises,carry out inspections and unannounced inspections on business and use units,and supervise third-party platforms for network operations.The Municipal Bureau will strengthen the supervision of operating enterprises and user units,focusing on strengthening the supervision of third-class operating enterprises and second-level and above(including)medical institutions,and carry out cause-related inspections and unannounced inspections on operating and user units.County bureaus make good use of the power of grassroots supervision offices to strengthen supervision of first-and second-class operating enterprises and medical institutions below second-class.


  Kong Fanpu emphasized that those who violate the law will be punished.Regarding the registrants,record holders,production and operation enterprises,and user units that violate the provisions of the Regulations in one of the following circumstances,including deliberately committing illegal acts or committing gross negligence,the circumstances of the illegal acts are serious,the nature is bad,and the illegal acts cause serious In case of consequences or other serious adverse social impacts,in addition to penalizing the unit,the legal representative,the main person in charge,the directly responsible person in charge,and other directly responsible persons may also be fined 30%or more and less than one time of their previous year’s income.


  Speed​​up the construction of a team of full-time inspectors


  In terms of building a team of professional inspectors,Kong Fanpu stated that he will speed up the establishment of a team of full-time inspectors at the national and provincial levels,set the ratio,qualifications and conditions of inspectors based on the workload of the two levels,and implement hierarchical and classified management of inspectors.Incentive and restraint mechanisms such as assessment,salary,promotion,etc.,enable outstanding talents to be recruited and retained.The focus of the General Administration is to build a team of high-level full-time inspectors with international inspection capabilities,enrich inspectors,guarantee inspection funds,increase inspection efforts,and strive to achieve full coverage of imported high-risk products.The provincial level also estimates the inspection workload,and scientifically calculates the ratio of inspectors in accordance with the number of first,second,and third types of production enterprises and the annual inspection frequency of various enterprises.Localities can make calculations based on the production enterprises in their jurisdictions and with reference to the calculation methods of the General Administration.


  Formulate rules for the supervision of imported medical equipment agents


  Regarding the supervision and management of import agents,Kong Fanpu introduced that the"Measures for the Supervision and Administration of Imported Medical Device Agents"are currently being formulated.


  The specific ideas mainly include:clarify the quality responsibility of the import agent;fully reflect and implement the specific provisions of the agent for the quality responsibility of imported medical device products,clarify that the agent is responsible for the authenticity and legality of the products they represent,and the products they represent Quality and safety assume corresponding legal responsibilities;clarify the legal relationship.The foreign registrant or recorder’s authorization of the agent must be certified by the country’s notary office and certified by the Chinese embassy or consulate in that country,or fulfill the requirements of the certification procedures stipulated in the relevant treaty between my country and the country where the evidence is located to ensure The legal effect of the power of attorney;realizing the full life cycle supervision of imported medical devices.Put forward regulatory requirements for pre-marketing registration agents and post-marketing product traceability,adverse event monitoring,re-evaluation,recalls,etc.,and emphasize the establishment of a quality management system.Agents are required to know the sales situation of the imported products they represent in my country to ensure that the product flows can be traced;conditions are set for agent access.Through restrictions on access capabilities,personnel,and scale,clarify the responsibilities and obligations of the agent,improve the ability of the agent to bear legal responsibilities in the industry,and clarify the work requirements of the supervisory department.Clarify the responsibilities and rights of the food and drug regulatory authorities at all levels,empower the supervisors with supervision and inspection rights,and put forward specific requirements for the implementation of supervision work.


  Speeding up medical device review and approval


  Xu Wei,Deputy Director,Medical Device Technology Review Center,State Food and Drug Administration


  At the medical device summit seminar,Xu Wei,deputy director of the Medical Device Technology Review Center of the State Food and Drug Administration,summarized the medical device technology application approval work in recent years,and introduced the next key work of the device review center.


  Efficient completion of medical device review


  Xu Wei pointed out that in recent years,the device review center has overcome difficulties and successfully completed the medical device review task despite the increase in work tasks and the shortage of manpower.In the past three years,the number of tasks received by the Medical Device Technical Evaluation Center of the State Food and Drug Administration was 11,129 in 2015,10,815 in 2016,and 6,848 in the first nine months of 2017.Through the efforts of the center,10,629 tasks have been completed.,10917 items and 8153 items,which basically ensured the balance of entry and exit of product review items.In July of this year,the center smoothly undertook the administrative examination and approval of the third-class,imported medical device licensing items and renewal of registration.As of the end of September 2017,a total of 1,893 products had been administratively examined and approved.


  In terms of encouraging medical device innovation,Xu Wei said that since the start of the priority review process in January 2017,the Device Review Center has received 33 applications for limited priority review and 687 applications for special approval for innovative products by the end of September.Items,143 administrative approvals were passed.


  Xu Wei introduced that the Device Evaluation Center vigorously promoted the review mechanism reform,optimized the review mechanism and process,and comprehensively reviewed the center's existing review process.Steadily carry out innovation review review and priority review review.Actively promote the construction of the review quality system,formulate and issue the"Medical Device Technical Review Quality Management Specification(Trial)",and continuously improve the review management system.Standardize the management of the expert advisory committee,formulate the"Administrative Measures for the Medical Device Technical Review Expert Advisory Committee",revise the"Expert Consultative Committee Operation Specification",actively carry out external communication,and the center has issued the"Medical Device Technical Review Consulting Management Specification",Issued the"Medical Device Review Communication Management Measures"to comprehensively promote the reform of the personnel system,continuously strengthen the support of informatization,and further expand the content of medical device review information publicity.


  Deepen the reform of the review mechanism


  Regarding the focus of the next step of the device review center,Xu Wei said that after the"two offices"opinions are released,the center will further deepen the review mechanism reform,including establishing a project manager system,continuing to improve the project team review system,and improving clinical evaluation related Review requirements,actively promote the construction of the review quality management system,and implement the expert advisory committee system.


  At the same time,the center will vigorously encourage the research and development of innovative medical devices,continue to do a good job in the review of innovative products,and further revise and improve the"Innovative Medical Device Special Approval Application Review Operational Specification"and"Medical Device Priority Review Application Review Operational Specification(Trial)",To do a good job in the review of special medical devices that require clinical treatment,in particular to strengthen the technical support role of the review,strengthen the revision of the guidelines,and organize the completion of the 200 technical review guidelines for medical devices required by the"13th Five-Year Plan"The preparation of 52 guidelines for medical devices in 2017.Cooperate with the General Administration in the revision of relevant laws and regulations,and actively participate in international regulatory exchanges.Promote the reform of the personnel system,study and review the construction of a new system,continue to promote the selection and employment of talents,and carry out the management of all-staff positions.In addition,it will continue to improve the future-oriented informatization of medical device review,optimize the reengineering review system,research and carry out online application review,establish a complete medical device data file,and actively promote the public service of device review informatization.


  The"Golden Decade"of medical equipment has considerable market potential


  Tao Jianhong,Deputy Director of CFDA Southern Institute of Pharmaceutical Economics,Editor-in-Chief of"Pharmaceutical Economic News"


  According to statistics,my country's medical device industry as a whole is characterized by multiple,small,scattered,and low levels.Among the 15,000 medical device manufacturers,more than 90%are small and medium-sized enterprises with a scale of less than 20 million yuan,and there are only about 300 to 400 companies with an annual output value of more than 100 million yuan.The industry concentration is low.Regional development is unbalanced.The industry is mainly concentrated in the Yangtze River Delta,which is dominated by disposable equipment and consumables.The Beijing-Tianjin-Bohai Bay where digital medical equipment such as DR,MRI,and digital ultrasound is developing rapidly,is based on comprehensive high-tech medical equipment products.The strengths of the Pearl River Delta.Enterprises have insufficient R&D investment,large gap in strength,and low local share of high-end equipment.


  However,these objective problems,in the view of Tao Jianhong,deputy director of the CFDA Southern Institute of Pharmaceutical Economics and editor-in-chief of"Pharmaceutical Economics",are also opportunities for the industry.Tao Jianhong pointed out that compared with the 1:1 ratio of devices and drugs in the US market,the Chinese market is only 1:5.my country's medical device industry has a very large room for growth,and there are many undeveloped blank markets.The endogenous market growth potential is very considerable.Demand urgently needs to be released.


  The pace of innovation accelerates


  From the"Thirteenth Five-Year Plan"of the pharmaceutical industry in recent years,the"Opinions on Reforming the Review and Approval System of Drugs and Medical Devices",and the"Announcement on Priority Approval Procedures for Medical Devices(2016 No.168)",we can see that,Innovative products with obvious clinical advantages have become the direction of policy encouragement,and innovation has become a hot word in the medical device industry.On the one hand,my country's medical device companies have gradually shifted their development perspective to research and development,and investment in innovative technology research and development has continued to increase;on the other hand,affected by the bidding and fee control policies,the pace of import substitution of high-end medical devices such as cardiovascular stents and imaging equipment has accelerated.


  Tao Jianhong pointed out that with the emergence of technological innovation and import substitution trends in the high-end medical device industry,the logic of rapid industry growth will be mainly driven by four major factors:the aging of the medical insurance payment will bring continuous market expansion and demand release;Domestic medical equipment has gradually achieved breakthroughs in technical barriers and product updates;hierarchical diagnosis and treatment,encouraging social capital to run doctors to drive the demand for equipment procurement in the grassroots market and private hospitals,financial support has continued to increase;China’s health expenditure and national equipment use accounted for There is still much room for improvement.


  Cultivate corporate competitiveness


  In addition,the"two-invoice system"has gradually begun to be applied to the field of high-value consumables and other medical devices,which places higher requirements on operating companies,such as improving quality standards and establishing a traceability system.Companies that are difficult to adapt to the new situation will usher in mergers.Restructuring,capable companies can concentrate their capital to carry out industry mergers and acquisitions.


  In fact,whether it is a manufacturing company or an operating company,learning from the small-to-large-scale development experience of leading European and American medical device companies,mergers and acquisitions have always been an important means of development.Building a whole industry chain platform integrating equipment,medicines,medical services,and mobile medical services through endogenous extension may form a stronger competitiveness.


  The next ten years will be the golden decade of China's medical device industry.How to fully grasp the opportunities in it and actively seek its own development to the greatest extent is a proposition that every company should think about.

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