ArticleI The procedures are drawn up according to the relevant regulations of MedicalDevice Registration and Management Measures (CFDA Order No. 4) and In VitroDiagnostic Reagents Registration Management Measures (CFDA Order No. 5) so asto execute the examination and verification of medical device registrationquality management system.
ArticleII The procedures are applicable to the examination and verification ofdomestic class III medical device registration and quality management system.
ArticleIII Food and drug administration departments of provinces, autonomous regionsand municipalities directly under the Central Government are responsible forthe examination and verification of domestic class III medical deviceregistration and quality management system, and if necessary, the technicalappraisal institutions of China Food and Drug Administration (hereinafterreferred to as CFDA) participate in the examination and verification.
ArticleIV The technical appraisal institutions of CFDA shall notify the correspondingfood and drug administration departments of provinces, autonomous regions andmunicipalities directly under the Central Government to carry out theexamination and verification of the registration quality management systemwithin 30 working days upon receiving the materials of domestic class IImedical device registration application materials. In case that the technicalappraisal institutions of CFDA are involved in the examination andverification, the food and drug administrations departments of all provinces,autonomous regions and municipalities directly under the Central Governmentshall be notified.
ArticleV The registration applicants shall submit the system examination andverification materials to food and drug administration departments ofprovinces, autonomous regions and municipalities directly under the CentralGovernment within 10 working days after the registration application ishandled. The registration applicants shall be responsible for the authenticityof the content of the submitted materials.
ArticleVI Food and drug administration departments of provinces, autonomous regionsand municipalities directly under the Central Government shall carry out thequality management system examination and verification related with product developmentand manufacturing according to Medical Device Production Quality ManagementRegulations and the requirements of related annexes.
Duringthe examination and verification, the authenticity of the samples registeredand tested by the examination and verifications and the samples for the use ofclinical trial shall be examined and verified simultaneously. Emphasis shall belaid to review the records related with the schemes and controls implementedduring the design and development, the purchase records used for sampleproduction, production records, testing records and sample reservation andobservation records.
ArticleVIII Food and drug administration departments of provinces, autonomous regionsand municipalities directly under the Central Government check the examinationsof the system examination and verification submitted by the registrationapplicants; the contents of site inspection are arranged according to thespecific circumstances and avoid repeated inspections according to theenterprise conditions, supervision and inspection, the products to beregistered in this application and production conditions and process comparisonof the products that pass the examination and verification.
In casethat the products have the same working principles and expected applicationsand share the basically same structural composition, production conditions andproduction process, only the authenticity of the samples to be registered andtested and the samples for the use of clinical trial shall be examined andverified in site inspection. Emphasis shall be laid to review the recordsrelated with the schemes and controls implemented during the design anddevelopment, the purchase records used for sample production, productionrecords, testing records and sample reservation and observation records.
ArticleVIII Where the system examination and verification materials submitted by theregistration application conform to the requirements, the food and drugadministration departments of provinces, autonomous regions and municipalitiesdirectly under the Central Government shall complete the quality managementsystem examination and verification within 30 working days upon receiving thenotice of system examination and verification. Where the registration applicantcannot submit the satisfying system examination and verification materials andsubsequently the system examination and verification cannot be carried out, thedelayed time shall not be included into the working time of examination andverification.
In casethat the technical appraisal institutions of CFDA are involved in theexamination and verification, the food and drug administrations departments ofall provinces, autonomous regions and municipalities directly under the CentralGovernment shall notify the CFDA appraisal institutions in the written form 5working days before the site inspection.
ArticleIX The inspection group shall formulatethe site inspection scheme before the implementation of site inspection. Thecontents of site inspection scheme include: enterprise basic situations,varieties to be inspected, inspection purpose, inspection basis, time of siteinspection, schedule, inspection items, and members and duties of inspectiongroup. The duration of site inspection is 1 to 3 days; in case the inspectioncannot be completed within 3 days, the time can be prolonged properly.
Theinspection group shall consist of 2 or more inspectors, and the municipal foodand drug administration department in the region where the enterprise islocated may designate one observer to participate in the site-inspection. Ifnecessary, food and drug administration departments can invite relevant expertsto participate in the site-inspection.
ArticleX The leader of the inspection group shall assume the responsibility of siteinspection. The leader of the inspection group shall organize the firstconference and last conference of site-inspection and the internal conferenceof inspection group, and assume the responsibility of the summarization ofsite-inspection materials, and examine and approve the conclusions of thesite-inspection.
ArticleXI When the site-inspection is started, the first conference shall be held. Thefirst conference shall be attended by members of inspection group, observers,enterprise persons-in-charge and / or management representatives, and relevantpersonnel. The contents include range of confirmatory inspection, schedule ofinspection implementation, announcement of inspection disciplines andprecautions, and confirmation of enterprise contacts.
ArticleXII The inspectors shall carry out the inspection according to the inspectionschemes, and shall record any problem that is found during the inspection.
ArticleXIII During the site-inspection, the inspection group shall hold an internalconference to exchange opinions about the inspection, study the difficultproblems and propose the solutions, and collect evidence if necessary. Beforethe end of the inspection, the inspection group shall hold an internal conferencefor summarization and evaluation, and record the true information. During theinspection group internal conference, the enterprise staffs shall withdraw.
ArticleXIV At the end of the site-inspection, the final conference shall be held. Thefinal conference shall be attended by members of inspection group, observers,enterprise persons-in-charge and / or management representatives, and relevantpersonnel. During the conference, the inspection group shall report thesite-inspection details to the enterprise, and the enterprise shall confirm thedetails of the site-inspection. In case of any objection to the questionsdetected during the inspection, the enterprise shall provide writteninstructions.
ArticleXV The inspection group shall issue suggestions and conclusions for thesite-inspection, and the suggestions and conclusions are categorized into threeparts: “pass inspection”, “recheck after rectification” and “not passinspection”.
ArticleXVI Food and drug administration departmentsof provinces, autonomous regions and municipalities directly under the CentralGovernment shall examine and verify the site-inspection materials submitted bythe inspection group, and propose the examination and verification conclusions;the conclusions are categorized into three parts: “pass examination andverification”, “recheck after rectification” and “not pass examination andverification”.
ArticleXVII In case of the need of recheck after rectification, the enterprise shallsubmit the recheck application and rectification report in one time to theoriginal examination and verification department within 6 months. The originalexamination and verification department shall complete the rechecks within 30working days upon receiving the recheck application.
If therecheck application and rectification report are submitted within the timelimit and the requirement of “pass examination and verification” cannot bereached after rectification and rechecks, the examination and verificationconclusion is “not passing examination and verification after rectification”.In case of passing examination and verification after rectification, theexamination conclusion is “passing examination and verification afterrectification”.
ArticleXVIII Food and drug administrationdepartments of provinces, autonomous regions and municipalities directly underthe Central Government shall sent the original copy of examination andverification result notice to the technical appraisal institution of CDFAwithin 10 working days after obtaining the conclusion of “passing examinationand verification”, “passing examination and verification after rectification”,“not passing examination and verification” and “not passing examination andverification after rectification”.
ArticleXIX If the examination and verification are not passed, the technical appraisalinstitution will not give the appraisal and comments on the registration, andthe food and drug administration departments will not make the decisions onregistration
ArticleXX The procedures shall come into effect as of the date of its promulgationFood and drug administration departments of provinces, autonomous regions andmunicipalities directly under the Central Government can formulate theexamination and verification of domestic class II medical device registrationand quality management system according to the procedures.
Issuedon June 08, 2015
