In order to implement our policy Some measures on optimizing the registration, review and approval of class II medical devices requirement,Continuous deepening Tube release suit reform,Continuously optimize the business environment,Promote the high-quality development of medical device industry in our province,according to Regulations on 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  State Drug Administration Announcement on matters related to the production of imported medical device products by enterprises in China  2020Year104number ,Combined with the former State Food and Drug Administration Announcement on matters related to handling product registration and production license when domestic medical device manufacturing enterprises set up new enterprises across provinces  2015Year203number Document requirements,Our bureau has formulated Guidelines for registration and application of listed class II medical devices in Guangdong Trial  ,The relevant contents are as follows:

one Scope of application

Inter provincial merger Reorganized or provincial enterprises belonging to the same group,Apply for moving the products that have obtained the registration certificate of class II medical devices outside the province to our province for registration,No substantial change in product.

two Declaration requirements
 Provincial bureaus establish communication channels,Organize the evaluation department to communicate with enterprises in need,See the attachment for the communication and consultation methods before acceptance.Those that fall within the scope of application of these guidelines after communication,The review department shall intervene in advance,Organize the verification of the quality management system for medical device registration.Verified,Registration application materials submitted by enterprises and verification results of registration quality management system.

one Application materials

The applicant for registration shall Announcement on publishing the requirements of medical device registration application materials and the format of approval certificates  State Drug Administration2021Year121number   Announcement on publishing the requirements for registration and application materials of in vitro diagnostic reagents and the format of approval certificates  State Drug Administration2021Year122number Such as submitting registration application materials.among,medical apparatus and instruments/Overview of in vitro diagnostic reagent products Non clinical data Excluding registered inspection report  Clinical evaluation data,Certified medical devices can be submitted/Original registration application data of in vitro diagnostic reagents.

For products to be registered,Those that continue to be produced in the original production enterprise,And production conditions Including production address Production factors, etc Unchanged,The registered inspection report can be submitted as the report submitted when the original certificate was obtained.

two Technical review

Clear product classification Clinical evaluation evidence is sufficient,During the technical review, the integrity of mandatory standards can be adopted only for the product inspection report Review the applicable national standards for reagent products,The time limit for technical review shall not exceed5Working days.Unclear product classification or insufficient clinical evaluation evidence,Technical review shall be carried out according to normal procedures.

three Registration verification

The applicant for registration shall ensure that the main production process for the production of the included products,It also promises that the main raw materials and production processes will not change,Provide product production quality management system to meet Medical device production quality management specifications And self inspection report in Appendix.

During the registration verification, we should focus on whether the system changes brought by the change of production process will generate new risks,Change of registered items.Self produced by the registration applicant,The review department shall The verification procedures for the registration quality management system of class II medical devices in Guangdong Province clearly include: ,s%s.s%s,s%s s%s  s%s 2022 21s%s s%s.

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