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Q：
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Is on-site verification mandatory for the filing of Class II medical device business operations?
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A：
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It is no longer a "mandatory inspection" and has been adjusted to be carried out "when necessary". On-site inspections will only be initiated for enterprises with high risks or those that have received complaints and reports, and routine filings can be completed immediately upon submission.
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Q：
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Is the quality supervisor required to be full-time when applying for a Class III medical device business license?
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A：
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The quality supervisor must sign a labor contract with the enterprise and have social security contributions paid continuously for more than 6 months. Part-time arrangements or "name lending" (unauthorized affiliation) will directly result in the license application being rejected.
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Q：
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Are there rigid requirements for the area of the business premises and warehouse when operating Class III medical devices?
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A：
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There are clear requirements. The usable area of the business premises for Class III medical devices shall not be less than 30 square meters, and the usable area of the warehouse shall not be less than 40 square meters. The warehouse must be set up independently and shall not be shared with other enterprises.
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Q：
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Can the filing of Class II medical device business operations be completed on the spot?
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A：
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Applications with complete and compliant materials can be reviewed and approved on the spot to finish the filing. The drug regulatory authority will carry out on-site verification as needed within 3 months after the filing. Those that fail to meet the requirements will be ordered to rectify or have their filing cancelled.
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Q：
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What is the processing time limit for applying for a Class III medical device business license?
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A：
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The district-level drug administration department shall complete the material review and on-site inspection within 5 working days from the date of accepting the application, and make a licensing decision within 20 working days. The rectification period is not included in the review time limit.
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