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What are the requirements for the storeroom for the business filing of Class II medical devices in Shanghai?

Many enterprises that want to apply for the business record of Class II medical devices will be baffled by the address problem. For example, President Yang, the registered address is in Minhang, and the actual address is also in Minhang, which is not in the same place, but he does not want to change the address. After all, it is an old enterprise, and it is too troublesome to change it. So he specially called the teacher and communicated with him. The teacher said, in this case, you can apply without changing the address.

Application instructions:

All China Netcom Office:

1. For paperless processing, the application form will be automatically generated after the information is filled in online, and submitted after the online signature and seal of the Legal Person One Pass;

2. The original documents shall be scanned and uploaded in pdf format, and other materials shall be uploaded in Office format. All uploaded documents shall be clear and accurate, and shall be submitted after being signed and sealed online by Legal Person One Certificate;

3. The application materials shall be in Chinese. For the application materials translated from foreign language materials, the original text shall be provided at the same time.

Paper materials:

1. The application materials shall be complete, clear, accurate, and shall be sealed or signed at the place where they are altered, and those required to sign shall be signed, stamped with the official seal of the enterprise, printed or copied on A4 paper, and bound into a volume according to the order of the application materials;

2. Where a copy of the application materials is required, the applicant must sign on the copy for confirmation (this copy is the same as the original), indicate the date and affix the official seal of the enterprise;

3. The application materials shall be in Chinese. For the application materials translated from foreign language materials, the original text shall be provided at the same time.

Handling method:

1. Receiving. The applicant submits the application materials through the comprehensive window of the enterprise service center, the unified acceptance platform of "All in One Network", logistics express, etc. The receiving staff shall review the application materials submitted by the applicant according to the catalogue and form standards of the application materials.

2. Acceptance. The acceptance staff shall review the application materials according to the acceptance conditions, and accept the application materials that are complete and conform to the legal form; If the application materials are incomplete or do not conform to the legal form, the applicant shall be informed of all the contents that need to be supplemented and corrected at one time.

3. Review. The handling personnel shall review the application materials on the spot.

4. Decision. If the application materials are complete and conform to the legal form, the handling personnel shall make a decision to approve the application on the spot.

5. Certificate preparation and service. The handling personnel shall, according to the approval decision, prepare the Class II Medical Device Business Filing Certificate on the spot and deliver it to the applicant (or deliver it by logistics express or other means as required by the applicant).