enclosure1 

On optimizing the second class medical devices in Guizhou Province

Several measures for review and approval

       To conscientiously implement the newly revised Regulations on the supervision and administration of medical devices And its supporting regulations,Continue to promote the reform of medical device evaluation and approval system,Adhere to innovative development,advance Pipe laying suit reform,Optimize the review and approval process of our province,Further improve the efficiency of review and approval,Promote the high-quality development of medical device industry in our province,The following measures are proposed.

one Reduce the time limit for review and approval

The registrant applies for the first registration of class II medical devices Change registration Continuation of registration,The application materials submitted are complete,Without correction,The processing time limit is reduced to42Working days.

two Optimize review procedures

Comprehensively accelerate the registration and declaration process Improve the efficiency of registration review.Mature design Products with clear technical requirements shall adopt internal review mode No application in the province No review guidelines The product structure principle and scope of application are complex Clinical trials and other products with certain safety risks are required Such as active medical devices In vitro diagnostic reagents and other products ,External experts need to be invited to participate in the review,Establish an early communication and coordination mechanism with external experts,Technical review compressed to30Completed within working days.

three Optimize on-site inspection procedures

one Having passed the inspection of the quality management system and obtained the registration certificate at the first registration,Apply for the same production range again at the original production address within two years  Classification catalogue of medical devices  Secondary product category Product registration,Or the products applied for the first registration have the same production conditions as the products for which the enterprise has obtained the registration certificate Production process,Exempt from on-site inspection or simplify on-site inspection items,Focus on product traceability information and production inspection capability.

two except It is a product registered for the first time by a newly established enterprise Products with new production range Products that provide registration self-test reports Commissioned products outside,The verification of medical device registration quality management system is carried out through data review,Carry out on-site system assessment when necessary.

three When the registrant applies for the first registration of multiple products at the same time,It is necessary to carry out on-site verification of the medical device registration quality management system at the same production address,Parallel connection is an on-site inspection.

four Carry out package service

When the registrant applies for the first registration of class II medical device products,Applying for the production license of medical devices or increasing the production scope at the original production address,And when the registrant applies for continued registration of class II medical device products,Applying for change registration of this product,Trial synchronous application,Parallel approval.

five Establish a research review linkage communication service mechanism

Registrant in the process of product development,Establish a working mechanism for communication and coordination with registrants and liaison officers,Through early intervention Specially assigned person On site guidance Provide technical assistance to registrants through whole process tracking and other methods,Product development in progress Registration declaration On site inspection and other aspects of point-to-point help enterprises,Reduce correction work,Improve the efficiency of registration review.

six Support the landing of high-quality medical device products from other provinces and cities in Guizhou

Medical device manufacturer that has obtained product registration certificate in other provinces and cities,Bringing registered products to the province for production,When applying for the first registration of such products in our province,Except product inspection report Biocompatibility and other research test data,Relevant application materials at the time of registration of raw products can be used.

seven Support the development of third-party inspection and testing institutions

Support the capacity building and development of third-party inspection and testing institutions,Strengthen cooperation with third-party inspection and testing institutions,Complementary to the inspection and testing capabilities of the provincial medical device testing center,Expand the scope and coverage of medical device inspection and testing in our province,Improve inspection efficiency.

eight Encourage and guide registrants to self check

Provincial medical device testing center through technical assistance Select and call the personnel of production enterprises to participate in the study of relevant variety inspection and hold training meetings,Promote production enterprises to improve the quality management ability of product life cycle inspection and testing.

nine Promote electronic review and approval

Strengthen information construction,Promote the registration of class II medical devices Paperless review and approval shall be fully implemented for production licensing matters,Implementation Review Examine and approve the data exchange and sharing of all links.

ten Strengthen supervision during and after the event

one The registrant shall organize the inspection within one month after obtaining the production license qualification of the first registered product or carrying out the entrusted production activities,It is found that there are illegal acts such as concealing the true situation or providing false materials,Handle strictly and severely according to law.

two Applying for the renewal of the production license of medical devices,After the enterprise submits relevant legal materials and makes a written commitment to carry out production activities in accordance with the medical device production quality management norms,stay2Make a decision on whether to grant the extension within working days.At the same time, after making a decision15Carry out on-site inspection within working days,For those who do not meet the requirements of medical device production quality management specifications,Handle according to law.

enclosure2

Some measures on optimizing the review and approval of class II medical devices in Guizhou Province Policy interpretation

        Some measures on optimizing the review and approval of class II medical devices in Guizhou Province  hereinafter referred to as  Several measures   Already on2022year6month29Daily release,Now Several measures Introduction background of Grasp the key points and main contents as follows

one Introduction background

    in recent years,The state has successively revised and issued Opinions on deepening the reform of evaluation and approval system and encouraging the innovation of drugs and medical devices  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  Measures for the supervision and administration of medical device production ,The registrant system has been established.Apply the rights and obligations undertaken by the registrant according to law to the development of medical devices production management Use full lifecycle,Make the safety of medical devices Effectiveness and quality controllability were further consolidated.In order to continuously promote the reform of medical device evaluation and approval system,Adhere to innovative development,advance Pipe laying suit reform,Optimize the review and approval process of our province,Further improve the efficiency of review and approval,Promote the high-quality development of medical device industry in our province,Our bureau has studied and drafted Several measures .

two primary coverage

     Several measures Focus on optimizing the review and approval time limit Improve the review and approval service system,Help enterprises transform technology into products,Quickly put into production,Simplify the approval process Less material Shorter time limit Better service,Strengthen supervision departments at all levels Guidance and communication between technology department and enterprise before applying for license,Strengthen supervision during and after the event,Promote the combination of supervision and service,Improve approval efficiency and service quality,Accelerate the transformation and upgrading of the medical device industry in our province High quality development.

three Key interpretation

     one Comprehensively reduce the time limit for review and approval,Optimize review and approval procedures.When the registrant applies for the registration license of class II medical devices,The application materials submitted are complete,Without correction,The time limit for technical review is reduced to30Working days,The approval time limit is reduced to12Working days,The total time limit for handling is determined by the statutory158Working days compressed to42Working days External experts need to be invited to participate in the review,Reduce the time limit for technical review of external experts that are not included in the work time limit to30Completed within working days.

     two Under the premise of combining the on-site verification of production license with the verification of product registration system,In depth optimization of on-site inspection procedures. Several measures Clarify the circumstances that can be exempted from on-site inspection or simplify on-site inspection items,And carry out an inspection Multiple coverage,Avoid double checking.

     three Trial parallel approval,Synchronous certificate issuance.Registrants can synchronously apply for product registration and production license according to their needs Registration change and renewal registration,The provincial drug administration carried out the review and approval work at the same time,At the same time, the medical device registration certificate shall be issued Registration change document and medical device production license,Improve the efficiency of government services,Shorten the transition time of enterprise production.

     four Chemical technology guidance service,Promote high-quality industrial development with policy optimization,Create a good business environment with high-quality services.Change service mode,Establish a research review linkage communication service mechanism,Early involvement in R & D and planning stage,In standard setting Provide technical support for plant construction, etc,And set up an expert service team to provide on-site services,Solve key and difficult problems in project construction for enterprises Support the introduction of high-quality medical device products from other provinces and cities to Guizhou,Relevant application materials at the time of registration of raw products can be used,Shorten the time when products are put into production Support the development of third-party inspection and testing institutions,Encourage and guide registrants to self check,Shorten the preparation time of registrants in our province before application Orderly promote paperless approval.

     five Implement the renewal commitment,Strengthen supervision during and after the event. Several measures Emphasize the supervision of registrants after carrying out production activities,At the same time, the renewal procedure of medical device production license was optimized,After the manufacturer submits relevant legal materials and makes a written commitment to carry out production activities in accordance with the medical device production quality management specifications,Make a decision in a short time,Strengthen post event supervision,Strengthen the punishment of illegal acts.