Product Compliance
Test/Filing/Registration
Product Compliance
Test/Filing/Registration
Notice of Guangdong Provincial Drug Administration on the official launch of the medical device production supervision system To further implement the new version Regulations on the supervision and administration of medical devices Measures for the supervision and administration of medical device production requirement,deepen internet+supervise work,Improve regulatory efficiency,Guangdong Province Intelligent drug supervision The construction and testing of the medical device production supervision system have been completed,The official version will be released on6month10Officially launched on August.Provincial medical device registrant Filed by Entrusted production enterprises can log in to the exclusive website of Guangdong intelligent food and Drug Administration Enterprises https://qy.gdfda.gov.cn/)-click Data submission - Legal person login - medical apparatus and instruments Menu to report the production variety information of medical devices Medical device enterprise report information Stop production Resumption of labor Major changes Escalation. Provincial medical device registrant Filed by The entrusted production enterprise shall Measures for the supervision and administration of medical device production Relevant requirements,Fill in relevant information carefully,Upload relevant materials,And the legality of the submitted materials real accuracy Responsible for completeness and traceability.In case of system operation and technical problems during the use of the system,Can call 020-37886123 Or joinQQgroup 719256878 Conduct consultation,For relevant policy issues, please contact the medical device supervision division of the provincial drug administration.
It is hereby notified. Guangdong Provincial Drug Administration 2022year6month7day |
Annex I User manual of medical device production supervision system-Enterprise sideV1.0
http://mpa.gd.gov.cn/zwfw/ywlcsm/ylqx/content/post_3945070.html Viewable
Annex II FAQ of medical device production supervision systemV1.0
Medical device production supervision system
frequently asked questions
Enterprise exclusive web page
Prepared by Digital Guangdong Network Construction Co., Ltd
Date of preparation 2022year5month
1. frequently asked questions
1.1. Business type problems
1 Approval date How to define the effective date
answer Registration certificate obtained in accordance with the new registration management measures,According to the approval date on the new registration certificate Fill in the effective date
Registration certificate obtained according to the old registration management measures,Approval date is the same as the effective date.
2 register keep on record card In the upload column,Whether to upload registration keep on record Change documents within the validity period of the certificate
answer No upload required.
3 Product technical requirements In the upload column,Whether it is necessary to upload the change document of product technical requirements
answer No upload required.
4 Only for new version Measures for the supervision and administration of medical device production Post implementation products,Or is it also required to way Report the information of production products before implementation,Including product information before implementation,be Commissioned production quality agreement In the upload column,in the light of2022year5month1Products for which the entrusted production record has been handled before September,Only entrusted production contract/agreement,Yes upload Record certificate of entrusted production still Commissioned production contract/agreement ,Or according to Guidelines for preparation of quality agreement for entrusted production of medical devices requirement,Supplementary commissioned production quality agreement
answer Approval completed on2022year5month1Future information of class II medical devices approved in Guangdong Province and all class II medical devices outside Guangdong Province Class I medical device products Class III medical device products.Approved on2022year5month1Class II medical device products approved in Guangdong Province recently,The system then synchronizes the product registration information of the license system Enterprises check and improve Supplement and upload relevant attachments to complete filling.
The production method is Commissioned production Commissioned production Need to upload Commissioned production quality agreement enclosure,no Commissioned production contract .
1.2. CACertificate issues
1.2.1. CACertificate login problem
1 The latest version of is installedCAassistant Netcom client4.3.0.5edition,Or prompt to download the latest versionCAassistant
answer It is recommended to reinstall the previous versionCAassistant.The installation package can be found in theQQGroup Group file Download in,Or add technical support personnelQQ 3378622150
2 CAAfter certificate renewal,Historical report data can not be seen,What should I do?
answer CAAfter certificate renewal,The certificate thumbnail is updated,stay CACertificate change registration form Registration information,Wait for technicians to handle it,CABinding information registration form CABinding information registration form
3 CAThe enterprise name of the certificate is inconsistent with the actual license enterprise name,The historical report data cannot be seen,What should I do?
answer Need to contact the technical personnel of Netcom,takeCAThe enterprise name on the certificate can be modified to be consistent with the enterprise name on the license.
Customer Service Hotline 400-830-1330
customer serviceQQ 4008301330
Official website of Netcom Guangdong e-commerce certification Co., Ltd (cnca.net)
4 Log in using a digital certificate,Tips This certificate is not supported by this platform,Please use the certificate supported by this platform
Or prompt Signature verification failed Signing failed
Confirm to use digital certificate CAcertificate Sign in.If yes,Follow the steps below
1 Press simultaneously win+r key,The run window appears in the lower left corner,inputmmcClick OK
Follow the above steps,Select all certificates,Right click Delete
Reinsert digital certificate,Refresh browser page,Log in.
1.2.2. Account and password login problem
1 If prompted after login Failed to obtain enterprise information ,What should I do?
Use legal person account Namely Enterprise account number Sign in.
2 How to retrieve the forgotten password
1.2.3. Provincial unified authentication account
1 Change of enterprise name,How to modify the enterprise name of a provincial unified authentication account
Click on the Enterprise name ,choice Account management - Modify data ,Fill in the graphic verification code SMS verification code,click determine ,Modify the enterprise name after successful authentication.
1.3. System operation problems
1 Product information filling page,After entering the registration certificate number of the product,Unable to get product name automatically Approval date Expiry date information.
answer Non system function problems,Incomplete database data,Except for class II medical devices approved in Guangdong Province,Other types of products can be filled in by the enterprise itself according to the actual situation.
2 Import attachment points many times,Exception in display request upload interface,Wait a little longer or more times to upload.
answer When the file size is large,Wait for a while to upload successfully.
3 Only the last product can be identified during batch uploading,Can't identify all.
answer The second line of the original import template is a prompt,Delete not allowed,By default, the system judges the import from the third line.After deleting the prompt in the second line,So the product in the second line does not recognize the import.
4 When submitting the second category products approved in Guangdong Province,Tips Product information cannot be searched in the system database,Please contact the technician ,Unable to submit,as follows
answer Class II medical device products in the province register keep on record Certificate number starts with Guangdong ,If not available,Provide product registration certificate documents,Feedback to the Consulting Group QQgroup 719256878 Technician handling.
5 Fill in product information Upload product attachments When clicking submit,Tips Background interface request exception ,What should I do?
answer 1 Check whether the uploaded attachments exceed20M,If yes,Compress the attachment or change to image format before uploading
2 Clean up browser cache,Login and upload again
3 Change to Google Chrome 360browser MicrosoftedgeBrowser upload again.
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+8618620497606