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Why is it difficult to pass the medical device registration verification and build a good quality management system to pass the last pass on the market?

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  • Time of issue:2017-12-15
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(Summary description)With the introduction of the concept of full life cycle management of medical devices,the standardization level of my country's medical device industry supervision has been continuously improved,and scientific supervision methods have begun to be implemented and improved one by one.According to statistics,since 2016,nearly 300 products have been actively withdrawn during the registration phase."The main reason is that there are defects or deficiencies in R&D compliance,risk management,clinical authenticity,and production specifications."Jiang Haihong,director of the medical device supervision department of Shanghai Medical College,explained it.

Why is it difficult to pass the medical device registration verification and build a good quality management system to pass the last pass on the market?

(Summary description)With the introduction of the concept of full life cycle management of medical devices,the standardization level of my country's medical device industry supervision has been continuously improved,and scientific supervision methods have begun to be implemented and improved one by one.According to statistics,since 2016,nearly 300 products have been actively withdrawn during the registration phase."The main reason is that there are defects or deficiencies in R&D compliance,risk management,clinical authenticity,and production specifications."Jiang Haihong,director of the medical device supervision department of Shanghai Medical College,explained it.

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2017-12-15
  • Views:0
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  With the introduction of the concept of full life cycle management of medical devices,the standardization level of my country's medical device industry supervision has been continuously improved,and scientific supervision methods have begun to be implemented and improved one by one.According to statistics,since 2016,nearly 300 products have been actively withdrawn during the registration phase."The main reason is that there are defects or deficiencies in R&D compliance,risk management,clinical authenticity,and production specifications."Jiang Haihong,director of the medical device supervision department of Shanghai Medical College,explained it.


  Recently,the first medical device registration verification key points and post-marketing supervision summit forum was held in Kunming.At the meeting,Yang Guang,deputy director of the Administrative Licensing Department of Guangdong Food and Drug Administration,who has been responsible for the registration of medical device products for a long time,said:"The verification of the quality management system for medical device registration is the last pass for product listing,which determines whether the product can be Registration and listing also undertakes the verification of a quality management system that guarantees the authenticity,safety,stability and reliability of listed products.The construction of a quality management system should arouse great attention from Chinese medical device companies."


  It is difficult to pass the registration verification once!


  The core of the medical device registration quality management system verification(hereinafter referred to as"registration verification")is to extend the inspection of the overall quality system of the enterprise through the verification of the research and development management,storage management,production management,inspection management,and department responsibilities of the applied product samples.The establishment and operation of the company can determine whether the quality management system established by the company can effectively analyze and control product risks,and then draw a conclusion on the authenticity of the company’s application for product samples.


  "From the actual situation,the one-time pass rate of the product registration verification of medical device enterprises is almost zero,even companies like Shenzhen Mindray have not passed the one-time pass."Yang Guang lamented.


  According to reports,in 2016,the Guangdong Provincial Bureau completed more than 700 registration verifications for Class II devices,plus 170 domestic Class III device registration verifications commissioned by the State Food and Drug Administration,and completed more than 870 product listing registrations.Verification work.Among them,10%were completely rejected once,and the rest basically had to go through"re-examination after rectification"before passing the inspection.


  Lin Feng,Director of the Medical Device Registration Division of the Shanghai Food and Drug Administration,also stated that most of the Shanghai medical device registration verification requires a“re-check after rectification”.Registration is granted.In the end,for a very small number of“failed to pass the verification”,the technical examination and approval department put forward an evaluation opinion for disapproval of registration.Product registration cannot be passed at one time.Enterprises that need to review after rectification should submit a review application and rectification report to the original inspection department at one time within 6 months.This not only wastes regulatory resources,but also delays the time to market products.


  "key item"is the key


  "After the implementation of the"Regulations on the Supervision and Administration of Medical Devices"revised in 2014,the original device quality management system assessment was changed to the registration quality management system verification,which is more demanding."Yang Guang introduced that based on the registration verification is the pre-market quality management system for medical devices The last pass of the verification is to shoulder the major responsibility of on-site verification of authenticity.Therefore,the registration verification has a veto power over whether the medical device can be successfully registered and listed.


  "Even if other registration materials and registration inspections are done well,it will not help."Yang Guang emphasized that after being rejected by one vote,the company needs to re-apply for registration,wasting valuable time and registration fees.Especially time to market,because all processes have to be re-queued.


  The 4 guiding principles of the"Medical Device Manufacturing Quality Management Regulations"and related appendices have more than 200 clauses.Among them,if one of the key items marked with a"*"does not meet the requirements,it is"failed the inspection";other non-critical items The project allows 3 to 5 items that do not meet the requirements,but the review suggested conclusion is"re-examination after rectification"."This means a lot of pressure for enterprises."Yang Guang said.


  According to Qiu Wanyu,deputy general manager and manager of Beijing Fuller Technology,the company accepts an average of 2 new product registration checks every year."In the"Guiding Principles for the On-site Inspection of Implantable Medical Devices in the Manufacturing Quality Management of Medical Devices",there are nearly 300 requirements for orthopedic materials,46 of which are key items,and each item must be treated with caution.One is not passed,This time the application for registration is completely abandoned."He said that any minor problems in the quality management system,even non-critical items,must be rectified as required,and registration is allowed only after passing the review.This will inevitably affect the time to market.


  According to Guangdong’s experience in medical device product registration and verification in recent years,it can be found that most companies are prone to problems in the following aspects:First,there are deviations in the understanding of the terms,such as not paying attention to the production address information,environmental monitoring report approval,and technical requirements are not divided Testing and type testing,etc.;second,there are problems in the application materials,such as the application product development and production address is not clear,the application product has not yet completed the design and development,does not meet the corresponding production conditions,and the hardware has serious defects;third,it is found to be irregular during on-site inspection Items such as the inability of the quality management system to meet product risk management,the lack of effective control over design and development,and the lack of substantive R&D activities.


  Quality management must be"systematized"


  Yang Guang said:"In order to meet the strict requirements of supervision,medical device companies must extend the management chain.Especially small and medium-sized enterprises,if they are tired of dealing with the increasing technical and business thresholds,they will easily fail to understand the importance of the quality management system.Neglect of management.Problems in the system mean that there are hidden dangers in quality.Companies must pay attention to this."


  "If it is to correct a hardware project,it will take a long time for the rectification and construction;if it encounters a key project defect,it will not be possible to pass the registration verification;if it is a soft clause problem such as document preparation and on-site operation,it is relatively easy to correct.Correct and scientific management concepts,cultivating outstanding full-time manager representatives,and doing a good job in the construction of a quality management system are the fundamental solutions."Yang Guang said.


  The Beijing Food and Drug Administration issued the"Beijing Medical Device Manufacturing Enterprise Manager Representative Management System(Trial)"on November 14,requiring that from January 1,2018,Beijing medical device manufacturing enterprises implement manager representative system.A clearly defined manager representative refers to a manager who has corresponding professional background or technical qualifications,and corresponding work experience in a medical device manufacturer,authorized by the person in charge of the manufacturer,and is fully responsible for the effective operation of the quality management system.Prior to this,Guangdong and Shanghai had respectively issued management measures on the management representatives of medical device manufacturers in 2010 and 2015.


  "Many start-ups only value the production technology itself,but ignore the establishment of a quality management system,lack of professional quality system management personnel,and the management system is full of loopholes."Li Yong,the manager of Shanghai MicroPort Medical Devices(Group)Co.,Ltd.,believes It is very necessary for medical device manufacturers to set up full-time manager representatives,and professional people should do professional things.Manager representatives can keep a record of the supporting documents of the system,and participate in the whole life cycle management of products from R&D,clinical,and production to post-market adverse reaction monitoring,follow-up and product recall.


  Yang Guang reminded that managers representatives of medical device manufacturers should strengthen their learning and understanding of laws and regulations and regulatory documents;supervisory authorities should also strengthen communication between supervisory inspectors and enterprises,promote mutual promotion of inspection efficiency,and speed up the approval and listing of medical devices.

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