Several measures of Guangdong Drug Administration on optimizing the registration, review and approval of class II medical devices

In order to implement the Implementation plan for promoting high-quality development of medical device industry in Guangdong Province  Guangdong Office letter 2021 366number ,Promote the comprehensive reform of medical device supervision in our province,Innovate the service mode of review and approval,Continuously improve the quality and efficiency of review and approval,Stimulate enterprise development power and market vitality,Promote the high-quality development of medical device industry,Better meet the needs of the public for safe use of machinery,Put forward the following work measures.

one Further optimize the review and approval process

1.Overall acceleration of review and approval.Realize the average reduction of the time limit for technical review of class II medical device registration in the province compared with the legal time limit50%.The time limit for the first registration review shall be determined by law60Days compressed to40Working days,Supplementary information of the applicant is required,The time limit for technical review after supplementary information shall be determined by law60Days compressed to30Working days.The time limit for administrative examination and approval shall be prescribed by law20Days compressed to10Working days.

2.Improve acceptance service efficiency.Scientific and reasonable formulation Unified and standardized acceptance standards and service guidelines,First registration,Check the integrity of the application materials in the acceptance process Compliance Guidance on consistency examination.Optimize acceptance services,Improve the electronic declaration function,Confirm that the applicant has submitted materials that meet the requirements,Avoid duplicate submissions Repeated correction,Improve the quality and efficiency of declaration.

3.Improve the sub path review mechanism.According to the difficulty and complexity of product review,Rational allocation of review resources,Implement sub path review.Continuously optimize the assignment rules of review tasks,Develop the product catalogue included in the simple review process,Establish independent review channel,Implement rapid review,Focus on product classification technical requirement Inspection report instructions Clinical evaluation and other relevant data.No product category adjustment Renewal registration items of mandatory standard changes,In principle, the time limit for technical review shall not exceed5Working days.

4.Improve the pre-trial service of correction.Unblock online consultation and communication channels,Guide the applicant to accurately understand the correction requirements,Improve the accuracy of correction.Improve the pre-trial management of supplementary and corrected materials,On major technical differences in communication,Expert consultation meeting or expert demonstration meeting shall be held.In the correction link, you can apply for the pre-trial inspection service of correction data,It can also directly submit correction data for technical review.The review department shall start from the date of receiving the pre-trial application15Reply within working days.For those who have passed the pre-trial,The pre-trial data is supplemented and corrected by default.

5.Optimize on-site inspection process.Improve the verification procedures of the registered quality management system,Carry out technical review and verification of registered quality management system in parallel.Combined with the daily supervision and quality credit of the enterprise,Adopt the combination of on-site inspection and data review,Whether to specify the specific situation of on-site inspection,Avoid double checking.Explore the combination of online and offline registration verification mode.On submitting self inspection report,Self inspection capability verification shall be carried out together with system verification.

6.Implement master document registration system.Gradually carry out the master document registration of class II medical devices in the province,Construction of main document registration platform and database.Develop a master document information guide for registration applicants,Simplified declaration materials,Standardize declaration behavior.For first registration Change registration applies to master document registration,After the evaluation department receives the registration application of related medical devices,Review the main documents together,Reduce repeated evaluation of raw materials and key components.

7.Simplified product registration and approval.Support listed imported products and products outside the province to move into our province for registration.The registrant of overseas medical devices shall be wholly-owned Enterprises established in our province in the form of joint venture or cooperation,And cross provincial mergers Reorganization or provincial enterprises belonging to the same group,When applying for the registration of class II medical devices,Relevant application materials at the time of registration of raw products can be used.Clear product classification The evidence of clinical evaluation is sufficient,During the technical review, the standards can be implemented only for the products Review the inspection report,In principle, the review time limit shall not exceed5Working days,The verification time of quality management system shall be calculated separately.

8.Unified technical review standards.Establish a technical review oriented,check Registration management technology system supported by inspection,Strengthen the preparation and revision of technical review points and inspection points of common products in the province.For inclusion List of medical devices exempted from clinical evaluation Some technologies in are mature Class II products with low risk,Exemption from submission of clinical evaluation data.Establish a working mechanism for multi-party consultation,Regularly coordinate and solve the review Technical problems encountered in inspection,Unified technical evaluation criteria for medical devices.

9.Strengthen product classification management.Highlight the basic role of product classification in the whole chain supervision,Establish classified consultation mechanism,Implementation Review test supervise Linkage and information sharing of all links of law enforcement,Timely study and solve the typical problems encountered in classified management.Optimize classification and definition workflow,improve work efficiency.Actively sort out common problems in classification and definition,Strengthen guidance,Reduce duplicate classification and definition applications.

two Strong support for innovation priorities

10.Whole chain support innovation projects.Projects applying for special approval procedures for innovation,intervention ahead of time,implementation one-on-one Special technical guidance.Products included in the special approval channel for innovation,In inspection assess The approval and other links shall be queued separately,On arrival inspection Trial on arrival Batch upon arrival.Strengthen advance service,Provide technical support for performance index evaluation and inspection method verification,Provide docking of clinical trial institutions for projects requiring clinical trials Clinical trial scheme guidance and other services.

11.Increase support for key projects.Belong to the country Provincial Party committee Projects supported by the provincial government's medical device industry development policies and new projects declared for the first time in the province,Included in the priority approval procedure,Compression time limit,Stand alone in line,Priority inspection and detection Registration verification Review and approval,Accelerate the listing of projects.

12.Establish the linkage working mechanism of research and review.Actively connect with emergency product registration Innovative product registration and other key supported projects,The applicant is allowed to submit R & D materials in a rolling manner according to the phased research progress,Inspection and review with delivery.Carry out on-site pre review,Strengthen face-to-face communication with enterprise R & D personnel.Realize the deep integration of technical review and on-site inspection,Adhering to science Speed up the work progress on the basis of ensuring safety,Lifting inspection Pertinence and efficiency of technical review.

13.Promote the innovation of medical device supervision in Dawan District.Expand the scope of clinical devices imported from Hong Kong and Macao designated medical institutions in Guangdong and Macao,Reduce the approval time limit for the first application of urgently needed clinical instruments,Optimize the non initial declaration process,Simplified application materials,Improve approval efficiency.Promoting clinical real world research of medical devices,Research data The results meet the requirements of the guiding principles,It can be used for registration and declaration of medical devices.

three Improve inspection efficiency through multiple channels

14.Optimize registration and inspection services.Implement whole process information management,Optimize registration inspection workflow,Parallel inspection Collaborative inspection,Improve inspection efficiency,Classification specification product inspection cycle,Open inspection time limit and progress,Strengthen the supervision of inspection time limit.A small number of projects for which the enterprise does not have the ability of self inspection Supplementary inspection items,Implement separate queuing,Check it out.

15.Standardize third-party inspection services.The Provincial Bureau website publishes the list of qualified third-party medical device inspection institutions,Update data regularly.Open registration and declaration system interface,Third party inspection institutions are encouraged to connect electronic inspection reports,It can be automatically obtained when the registration applicant submits materials.Establish inspection and consultation mechanism,Standard operating procedures for unified inspection items.

16.Improve the self inspection ability of enterprises.Build a communication platform for self inspection capability,Organize professional institutions to carry out training,Help enterprises improve the quality management ability of inspection and testing.The laboratory carrying out self inspection has passed the China National Accreditation Commission for conformity assessment CNAS Approved,Or the existing varieties have passed the self inspection ability verification or ability verification organized by the Provincial Bureau,The combination of data verification and on-site verification can be adopted,Focus on product technical requirements Differences in test methods,Avoid double checking.

four Comprehensively improve the licensing service level

17.Expand review and inspection resources.Support industrial concentration Qualified regions and provincial bureaus jointly build industrial service stations spot ,Strengthen regulatory capacity-building,Undertake consulting services and other review and inspection related work.Play the role of evaluation training base,Strengthen personnel training,Continuously enrich the review and inspection team.Further strengthen the management of local inspectors,Integrate inspection resources,Improve inspection efficiency.

18.Improve license information management.Further improve the province's electronic declaration system for medical device registration,Implementation inspection assess Approve the data exchange and sharing of all rings,Improve the Internet+Government service level.Add information confirmation link of medical device registration certificate,Reduce the error correction rate of registration certificate.Simplify the certification process,The certificate can be prepared and issued synchronously after approval.Sort out structured review data by category,Strengthen effectiveness evaluation,Continuous optimization and improvement.

19.Strengthen technical cooperation in review.Southern Institute of pharmaceutical economics Dawan sub center for technical review and inspection of medical devices of the State Administration of health and other departments shall establish a normalized cooperation mechanism,Jointly carry out research on innovative policy mechanism of review and approval Research and evaluation of cutting-edge technologies Preparation and revision of standards.Actively strengthen data analysis In depth docking of review and inspection,Drive and improve the ability of medical device registration, review and approval.

20.Broaden communication channels.Timely revise the communication system,Provide more convenient appointment consultation channels,Strengthen cooperation with enterprises Normal contact of social organizations such as trade associations,Allocate business backbone to participate in the review and answer questions on common problems,Promote the advancement of review and approval services.Enrich the staff of the consulting team,Through online communication,Provide coverage inspection register Full chain consulting service before clinical listing,Strengthen technical guidance to applicants.