Information related to the application of Class III medical device business license

Detailed introduction to Class III medical devices. Licensing application and business license application related information. A medical device business license is a license certificate that companies operating Class III medical devices must have.。Because Class III medical devices have a great impact on human health，The state also has very strict control over it，There are also many related directories。

If you are not sure about the classification of the medical devices you operate，You can contact Hong Kong Xintong customer service for detailed catalog reference.，This article will not go into details，It mainly introduces relevant information about application for Class III medical devices.。 Application focus

Registration process

Prepare information for application：Through the Guangdong Provincial Government Service Network，Search the name of the approval item "Medical Device Registration Approval"，Select "Issuance of Class II Medical Device Registration Certificate"。

Fill in the application information online，and upload relevant electronic documents。

1. Acceptance of materials submitted on site：The handling agency will confirm acceptance within 5 working days after receiving the application.。Materials are incomplete or do not comply with legal forms，Notify the applicant of all the necessary supplements and corrections within five days，Failure to notify after the due date，The application will be accepted from the date of receipt of the application materials.。
2. Waiting to get the processing result：You can log in to the Guangdong Provincial Food and Drug Administration website to check the processing progress.。

Electronic certificates have been implemented for this matter，No additional paper certificates will be issued，Applicants can apply for certification themselves，You can also go to the provincial bureau acceptance hall with your digital certificate to print the certificate yourself.。

Materials to prepare

1. Prepare the registered company；
2. Office address rental certificate，office、The actual usable area is more than 80㎡、floor plan；
3. legal representative、supervisor、Shareholder identity certificate；
4. legal representative、Business person in charge、Certificate of education or professional title of the quality manager、Medical certificate；
5. Relevant certificates for professional and technical personnel；
6. Medical device-specific system software；License period
7. Medical device business license (including in vitro diagnostic reagents) renewal；
8. New application and changes of medical devices (including in vitro diagnostic reagents)；
9. Class II medical devices need to be registered and deregistered；
10. Medical device online transaction service third-party platform’s first registration service；
11. According to the innovation needs of enterprises across the entire industry chain，Provide personalized consultation and services；

Application process

① Sign a service contract； ②Prepare application materials； ③Submit to the competent authority for review； ④ Pass the preliminary review； ⑤ Appointment specialist for on-site review，review； ⑥ Get the certificate after passing the reexamination；

About Hong Kong Xintong

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