Guangdong Drug Administration Office 2022 133number

Relevant units

In order to do a good job in the verification of medical device registration quality management system,according to Regulations on the supervision and administration of medical devices Administrative measures for registration and filing of medical devices Administrative measures for registration and filing of in vitro diagnostic reagents Verification procedures for the quality management system of class III medical device registration in China ,Combined with the actual situation of the province,Guangdong Provincial Drug Administration Hereinafter referred to as the Provincial Bureau The organization revised Verification procedure of registration quality management system of class II medical devices in Guangdong Province ,It is hereby issued,Effective today.Relevant work requirements are notified as follows

one Provincial Bureau evaluation and Certification Center Hang the brand of drug inspection center Hereinafter referred to as the evaluation center Be responsible for and undertake the verification of class II medical device registration quality management system,At the same time, undertake the technical review of the verification of the registration quality management system of class III medical devices On site inspection and data review.After the evaluation center receives the verification materials of class III medical device system transferred by the Provincial Bureau,Should be25Complete the verification within working days and put forward the verification conclusion.Requiring review after rectification,After the registration applicant submits the rectification report25Review shall be completed within working days.After the provincial bureau receives the verification conclusion of the evaluation center,Issue the notice of system verification results and submit it to the medical device technical evaluation center of the State Drug Administration.

two In case of special circumstances such as epidemic prevention and control,The evaluation center can carry out system verification in flexible ways such as online or offline combination.

enclosure Verification procedure of registration quality management system of class II medical devices in Guangdong Province

Office of Guangdong Provincial Drug Administration

2022year4month27day

enclosure

Verification procedure of registration quality management system of class II medical devices in Guangdong Province

Article 1  In order to verify the registration quality management system of class II medical devices,according to Regulations on the supervision and administration of medical devices Administrative measures for registration and filing of medical devices Administrative measures for registration and filing of in vitro diagnostic reagents Verification procedures for the quality management system of class III medical device registration in China ,Combined with the actual situation of Guangdong Province,Develop this procedure.

Article 2  This procedure is applicable to the verification of class II medical device registration quality management system within the jurisdiction of Guangdong Province.

Article 3  Guangdong Provincial Drug Administration Hereinafter referred to as the Provincial Bureau Take charge of the verification of the registration quality management system of class II medical devices in the province and carry out efficiency evaluation.Provincial Bureau evaluation and Certification Center Hang the sign of inspection center Hereinafter referred to as the evaluation center Be specifically responsible for and undertake the technical review in the verification process of class II medical device registration quality management system On site inspection Data review Conclusion validation and result notification.

Article 4  Verification of systems involving inter provincial commissioned production,The evaluation center may request the Provincial Bureau to negotiate with the provincial drug regulatory department where the entrusted production enterprise is located to jointly carry out or entrust to carry out on-site inspection.

Article 5  The evaluation center shall start from the date of receiving the application materials for medical device registration10Start system verification within working days,After startup30Complete all verification work within working days.After rectification,After the registration applicant submits the rectification report20Review shall be completed within working days.

Article 6  The evaluation center shall follow the medical device production quality management specifications and relevant appendices The requirements of the verification guide for registered quality management system and product development Verification of quality management system related to production.

During the verification process,At the same time, the authenticity of the registration applicant's inspection products and clinical trial products shall be verified.Focus on consulting the relevant records of implementation planning and control in the design and development process,Purchase records for product production Production record Inspection records and sample observation records, etc.

Submission of self inspection report,The ability of the registration applicant or the entrusted institution in the development process shall be inspected Focus on the inspection results.

Article 7  The evaluation center shall, according to the specific conditions of the registration applicant Supervision and inspection The comparison of production conditions and processes between the products applied for registration and the previously verified products,Arrange the contents of on-site inspection as appropriate,Avoid double checking.

The products have the same working principle Intended use,And has basically the same structural composition Production conditions Of production process,During on-site inspection,Only the authenticity of the enterprise's inspection products and clinical trial products can be verified,Focus on consulting the relevant records of implementation planning and control in the design and development process,Purchase records for product production Production record Inspection records and sample observation records, etc.

Article 8  Meeting one of the following conditions,In principle, only data review shall be conducted,Carry out on-site inspection if necessary

one Annual quality creditAClass production enterprise hereinafter referred to asAClass enterprise Application for registration of class II medical devices

two The original production address shall pass the system verification within one year Including the third type of system verification ,The application is applicable to the appendix of the same production quality management specification Specific appendix,See Appendix for customized denture,The same below ,Or the system verification that belongs to the first level product category of the classification catalogue and the product type is the same Product type refers to active passive sterile Custom denture Independent software, etc,The same below

three Medical device change registration It does not include on-site verification of self inspection capability and major production process changes that may affect the safety of medical devices Effective situation

four Other circumstances requiring only data review.

Article 9  Self inspection report submitted by registration applicant,Meeting one of the following conditions,In principle, only data review shall be conducted,Carry out on-site verification when necessary

one The relevant inspection scope of the self inspection laboratory has passed the China National Accreditation Commission for conformity assessment CNAS approval

two Within one year, products belonging to the first-class product category of the classification catalogue and of the same product type have passed the on-site verification of self inspection ability

three It has passed the self inspection capability verification organized by the Provincial Bureau

four All items in the self inspection report are inspected by qualified medical device inspection institutions

five The Evaluation Center believes that the self inspection items of the enterprise are relatively simple,Low requirements for inspection instruments and test methods

six Other circumstances requiring only data review.

Article 10  Has passed the system verification Including the third type of system verification ,When applying for system verification applicable to the appendix of the same production quality management specification within two years,On site inspection can only check the authenticity of products.

Article 11  Comply with Article 8 nine Circumstances specified in Article 10,The evaluation center shall verify the instructions and relevant certificates submitted by the registration applicant in the verification materials of the registration application system.

Article 12  On site inspection shall be carried out under the following circumstances:

one First application for initial registration of a new enterprise

two First registration application for production at new address barringAClass enterprise

three Carry out system verification according to the appendix of production quality management specification that has not been applied in the past barringAClass enterprise

four If the key items do not meet the requirements, recheck after rectification

five Other circumstances in which the on-site inspection should be carried out in the process of technical review.

Article 13  The evaluation center shall formulate an on-site inspection plan before carrying out on-site inspection.The on-site inspection plan includes: Basic information of the enterprise Check variety Inspection purpose Inspection basis On site inspection time Schedule Inspection items Inspection team members and division of labor, etc.The on-site inspection time is generally1to2day,as2The inspection cannot be completed within days,The time can be extended appropriately.

The inspection team shall be composed of2Above name contain2name Composition of inspectors,The drug regulatory department at the municipal level divided into districts where the enterprise is located may send1Observers attended the on-site inspection.When necessary,The evaluation center may invite relevant experts to participate in on-site inspection.For submitting self inspection report,Personnel familiar with the inspection shall be selected to participate in the inspection.

Article 14  The inspection team leader responsibility system shall be implemented for on-site inspection.The inspection team leader is responsible for organizing the first meeting of on-site inspection Final meeting and internal meeting of the inspection team,Be responsible for summarizing on-site inspection data,Review on-site inspection conclusion.

Article 15  At the beginning of site inspection,The first meeting shall be held.The first meeting shall be held by the members of the inspection team observer Person in charge of the enterprise and/Or management representative Participation of relevant personnel.The content includes confirming the scope of inspection Implement the inspection schedule Announce inspection discipline and precautions Determine enterprise liaison personnel, etc.

Article 16  The inspector shall inspect according to the inspection plan,Truthfully record the problems found in the inspection.

Article 17  During site inspection,The inspection team shall hold an internal meeting,AC inspection,Study difficult problems and put forward handling suggestions,Evidence shall be obtained when necessary.Before inspection,The inspection team shall hold an internal meeting,Summarize evaluate,And record truthfully.During the internal meeting of the inspection team,Enterprise personnel shall avoid.

Article 18  At the end of the site inspection,The final meeting shall be held.The final meeting shall be held by the members of the inspection team observer Person in charge of the enterprise and/Or management representative Participation of relevant personnel.The content includes that the inspection team informs the enterprise of the on-site inspection,The enterprise confirms the on-site inspection.Having objections to the problems found in the inspection,The enterprise shall provide written explanation and relevant evidence and supporting materials,The inspection team leader shall return it to the evaluation center together.

Article 19  The inspection team shall issue suggestions and conclusions for on-site inspection,The proposed conclusions are divided into clear through Recheck after rectification Failed inspection Three cases.

Article 20  The evaluation center shall start from the end of the on-site inspection5Review the on-site inspection data submitted by the inspection team within working days,Put forward verification conclusions,The verification conclusion is Through verification Recheck after rectification Failed verification Three cases.For those that need to be rechecked after rectification,The evaluation center shall inform the registration applicant of the contents to be rectified.

Article 21  Recheck after rectification,The evaluation center can verify through the data and the enterprise has no key project defects,In principle, on-site review will not be conducted.Registration applicant in6Time to complete rectification and submit rectification report within months,Not included in the review time limit.

Failing to submit the rectification report within the specified time limit,And still fail to meet the requirements after rectification and review Through verification Required,The verification conclusion is Failed to pass the verification after rectification .Passing the verification after rectification,The verification conclusion is Pass the verification after rectification .

Article 22  Due to force majeure,The registration applicant fails to accept the on-site inspection,The evaluation center may submit a written application to the registration applicant,One extension within the processing time limit.The registration applicant refuses to accept the on-site inspection of the quality management system without reason,The verification conclusion is Failed verification .

Article 23  The evaluation center makes a decision Through verification or Pass the verification after rectification or Failed verification or Failed to pass the verification after rectification After conclusion,The registration applicant shall be informed of the results by sending prompt SMS or providing web query.

Article 24  Failing verification,The evaluation center puts forward the evaluation opinions on the non registration of class II medical devices,The Provincial Bureau made a decision not to register.

Article 25  After the registration applicant completes the product inspection,Adjustment due to planning The production address needs to be changed for special reasons such as house demolition,The applicant may apply to the registration center in writing,Carry out product authenticity and corresponding system verification in advance before change.

Article 26  The verification of the quality management system shall strictly comply with laws and regulations Verification discipline,Keep state secrets and the secrets of the units under inspection,Comply with relevant requirements of integrity.

Article 27  The Provincial Bureau strengthened the supervision and guidance of the system verification,Find the deficiencies in the work in time,Further improve the working mechanism,Continuously improve the quality and efficiency of system verification.Dereliction of duty in work muddle with one 's duty Prevarication and procrastination,Causing adverse consequences,Seriously investigate the responsibility according to law.

Article 28  These procedures shall come into force as of the date of promulgation.The previous provisions are inconsistent with this procedure,This procedure shall prevail.Former Office of Guangdong food and Drug Administration On printing and distributing the verification procedures for the registration quality management system of class II medical devices in Guangdong Province provisional s%s s%s 2015 552s%s s%s.