PHDS HEALTHCARE RESEARCH Co., Ltd.
The five new regulations for medical devices by CFDA will be implemented simultaneously on October 1.
Release time:
2014-10-01
The five new regulations for medical devices by CFDA will be implemented simultaneously on October 1.
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New
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version Old
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Class I products Old
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Filing systemRegistration system
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Registration and filing subjects
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Enterprises or individuals
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Can only be enterprises
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Encourage innovation
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Special approval channels
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No green channel
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Clinical trial data
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Provide clinical evaluation data
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Provide clinical trial data
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Clinical trial approval time limit
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63
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working days to complete
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No such requirementTotal registration cycle
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128
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working days (Class III:
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221working days)Special device approvalMedical devices urgently needed for treating rare diseases and responding to public health emergencies: approval first, then complete registration
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No such provision
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No registration for unclassified products
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Can apply as Class III first
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Must first apply for classification definition, rigid
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Sales of registered components
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Under the condition of meeting
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'for the purpose of replacing consumables, after-sales service, maintenance, etc.'
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components can be sold separately2Interpretation of the 'Regulations on the Registration of In Vitro Diagnostic Reagents'Validity period of registration certificate4
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New
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versionOld
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Class I products Old
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Research reagents
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5year
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Cancelledyear
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Only for research, not for clinical diagnosis
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Used for research does not require registration
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Quality standards
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Product technical requirements2Product registration requirementsValidity period of registration certificate
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Timing of registration and clinical trials
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Class II and III products can only conduct clinical trials or apply for registration after passing registration inspection
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Start preparing clinical trial work as soon as product development is successful
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Clinical trials
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Obtain qualifications from clinical trial institutions, and also need to file first
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Provincial health medical institutions do not need to file
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3
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Interpretation of the 'Regulations on the Supervision of Medical Device Production'
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Production license
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Attached registration form, stating product name, registration number, etc.
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New
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versionOld
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Class I productsOld
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As long as the production scope is the same, no need to increase the application
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Setting up factories across provinces
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Can apply as Class III first
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Should apply separately for medical device production license
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Commissioned production
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The entrusted party is responsible for quality; except for special approvals, the entrusting party also needs production license and registration certificate
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Should indicate
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Entrusted production
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Can apply as Class III first
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words and the period of entrusted production
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Resumption of production
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words and the period of entrusted production
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Having similar products produced can be regarded as not having continuous suspension of production2After one year of suspension, verification is required to resume productionValidity period of registration certificateSelf-inspection system
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Can apply as Class III first
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Those who do not submit quality management self-inspection reports as required will be punished according to regulations
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Interpretation of the 'Regulations on the Supervision of Medical Device Operations'
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停产一年后，需核查才能恢复生产
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自查制度
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未按规定提交质量管理自查报告的，按规定处罚
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Can apply as Class III first
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New
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version Old
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Class I products Old
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Category Management
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Category I does not require a license or filing, Category II requires filing management, Category III requires licensing management
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Not clearly defined
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Entrusted storage
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If all medical devices are entrusted to other enterprises for storage, a warehouse does not need to be established
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Product Information Management
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Third-class medical device operating enterprises must have a compliant computer information management system to ensure product traceability
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Applicant entity
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Those engaged in the operation of third-class medical devices must have legal person qualifications
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Only2Name pre-approval noticeValidity period of registration certificateCan be
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Sales
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Sales personnel must have2Authorization letterValidity period of registration certificate, individuals without a license are not allowed to sell
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New business premises
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Should separately apply for medical device operating license or filing
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Can apply as Class III first
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自查制度
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Third-class medical device operating enterprises must submit an annual quality management self-inspection report
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Resume business
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If the business has been suspended for more than one year, it must report to the drug regulatory department when resuming operations
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Can apply as Class III first
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Wholesale and retail
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The new regulations distinguish between the wholesale and retail of medical devices
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Keyword:
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