2025深圳第三类医疗器械经营许可证办理

2025深圳第三类医疗器械经营许可证办理 2025深圳第三类医疗器械经营许可证办理 本文主要介绍2025年如何办理深圳第三类医疗器械经营许可证吗，以及办理条件和所需材料及流程。

one、深圳三类医疗器械经营许可证办理材料

1. "Medical Device Business Enterprise License Application Form"
2. "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department。
3. Application report。
4. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。
5. Business premises、Warehouse layout plan。
6. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。
7. List and academic qualifications of technical personnel、Copy of professional title certificate。
8. Business quality management specification document directory。
9. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。
10. Warehousing Facility Equipment Catalog。
11. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.;
12. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or person in charge himself，The enterprise should submit a "Power of Attorney"。
13. Apply for a confirmation letter of "Medical Device Business Enterprise License"。

two、深圳医疗器械经营许可证的办理

Require

1. The "Medical Device Business Enterprise License Application Form" submitted by the operating enterprise should be signed by the legal representative or stamped with the official seal of the enterprise.;
2. The items filled in the "Medical Device Business Enterprise License Application Form" should be filled in completely、precise，The content to be filled in should comply with the following

Require

。 A、"Company name"、The "registered address" is the same as the "Industrial and Commercial Business License" or "Notice of Pre-Approval of Enterprise Name"。

B、The business scope to be applied for shall be filled in according to the first-level catalog of the "Medical Device Classification Catalog" issued by the State Food and Drug Administration in 2002.。 C、"Registered Address"、When filling in the "warehouse address", the specific house number should be clearly stated.、Floor and room number。

1. Proof of identity of legal representative、Certificate of academic qualifications and professional title、The appointment document should be valid;
2. The copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department should be the same as the original，Copy to confirm and keep，Originals returned;
3. Property certificate、House rental certificate(The lessor must provide proof of property ownership)should be valid;
4. Business person in charge、Quality manager resume、Educational qualification certificate or professional title certificate should be valid;
5. Enterprises should establish medical device quality management files or forms based on their own actual conditions。
6. The self-guarantee statement on the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the company.，If there is no official seal，The signature or seal of the legal representative must be。
7. All application materials need to be submitted with copies，applicant(unit)The copy must be marked with the words "This copy is consistent with the original" or a text description，Date，Stamped with the official seal of the unit;Individual applications must be signed or stamped。
8. Application materials should be complete、clear、signature，And stamp each copy with the official seal，All application forms are typed and filled out by computer，Print on A4 paper，Use A4 paper for copying，Bind into a volume according to the order of the application materials catalog。

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