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Enterprise Operating Qualifications Requirements

Last updated: 2024-11-29 14:18:29

Enterprise customers applying to purchase and use TRP need to refer to the following enterprise operating qualifications requirements. Submit the corresponding materials through the Assurance Platform Management Backend for audit. Purchase and use can be completed only after the Assurance Platform audit is passed.
If the industry and business operations of the enterprise involve categories not covered in this document, sensitive categories, or if there are local special provisions or other special requirements (subject to the evaluation and audit of the Assurance Platform), the Assurance Platform will conduct additional special audits and evaluations, and the enterprise needs to cooperate by providing relevant materials.
All qualification documents need to provide scanned originals or photocopies (with the corporate seal). Provide a copy of the legal representative's ID card (the copy needs to include the legal person’s signature). The products sold must be within the permitted range of qualifications, all qualifications must be within the validity period, and the enterprise must ensure the qualifications remain valid during the use of the Assurance Platform.
Primary Category
Secondary Category
Qualification Requirements
Food
Primary Agricultural Products
None
Fresh Fruits and Vegetables
1. Please provide a <Food Business License> or a <Food Production License> or a <Border Port Health License>
2. For the sale of prepackaged food only, provide the <Prepackaged Food Filing Certificate> or <Business License> (the business scope must include prepackaged food)
3. Imported goods must submit the <Entry-exit Inspection and Quarantine Certificate> or <Entry-exit Inspection and Quarantine Sanitary Certificate>
Snacks
1. Please provide a <Food Business License> or a <Food Production License> or a <Border Port Health License>
2. For the sale of prepackaged food only, provide the <Prepackaged Food Filing Certificate> or <Business License> (the business scope must include prepackaged food)
3. Imported goods must submit the <Entry-exit Inspection and Quarantine Certificate> or <Entry-exit Inspection and Quarantine Sanitary Certificate>
Tea and Alcoholic Beverages
1. Please provide a <Food Business License> or a <Food Production License> or a <Border Port Health License>
2. For the sale of prepackaged food only, provide the <Prepackaged Food Filing Certificate> or <Business License> (the business scope must include prepackaged food)
3. Imported goods must submit the <Entry-exit Inspection and Quarantine Certificate> or <Entry-exit Inspection and Quarantine Sanitary Certificate>
General Food
1. Please provide a <Food Business License> or a <Food Production License> or a <Border Port Health License>
2. For the sale of prepackaged food only, provide the <Prepackaged Food Filing Certificate> or <Business License> (the business scope must include prepackaged food)
3. Imported goods must submit the <Entry-exit Inspection and Quarantine Certificate> or <Entry-exit Inspection and Quarantine Sanitary Certificate>
Grains, Oils, Rice, Flour
1. For businesses not selling salt, provide the <Food Business License> or <Food Production License>
2. For businesses selling salt, provide the following qualification materials:
(1) <Designated Production Enterprise Certificate for Salt>, <Food Business License>, or <Food Production License>
(2) <Designated Wholesale Enterprise Certificate for Salt> or <Salt Wholesale License [including transfer (substitute) wholesale]>
Poultry, Meat, Eggs
1. Domestic goods must provide: <Animal Epidemic Prevention Qualification Certificate>, <Quarantine Qualification Certificate>
2. Imported goods must provide: <Entry-exit Inspection and Quarantine Certificate> or <Entry-exit Inspection and Quarantine Sanitary Certificate>
Ready-to-cook Meals/Semi-finished Dishes
Provide the <Food Production License>, <Food Business License>, or <Prepackaged Food Sales Filing Certificate>
Tonic Health Products
Nutritive Supplements (Only General Food)
Please provide a <Food Business License> or <Food Production License>
Health Food
1. Please provide a <Food Business License> that includes health food sales, or a <Health Food Production Enterprise Hygiene License>, or a <Health Food GMP Certificate>
2. Health food that requires registration by law needs to provide a <Health Food Registration Certificate>
3. Health foods that require filing by law must provide Health Food Filing Information, Imported Health Food Filing. For health food production, also provide a <Food Production License>
Medical Health
Medical Devices
1. For Class I medical devices, please provide a Business License with the scope of business including this category
2. For Class II medical devices, please provide a <Class II Medical Device Filing Certificate> and a <Medical Device Online Sales Filing Certificate>. For the production of Class II medical devices, please submit a <Medical Device Production License>
3. For Class III medical devices, please provide a <Medical Device Business License> and a <Medical Device Online Sales Filing Certificate>. For the production of Class III medical devices, please submit a <Medical Device Production License>
4. If engaged in online sales of medical devices, the business license, filing status, and the registration or filing status of the medical devices being sold need to be reviewed. For self-built websites, the <Internet Information Service Value-Added Telecommunication Business License (ICP License)>, <Internet Drug Information Service Qualification Certificate>, and <Online Data Processing and Transaction Processing Value-Added Telecommunication Business License (EDI License)> (if involving online transactions) must be provided
5. Internet display information, if classified as an advertisement, requires the <Medical Device Advertising Approval Number>; if classified as a product display page, a prominent position must provide the <Medical Device Production and Operation License> or <Medical Device Registration Certificate> or the filing certificate, and the number should be displayed in text form
Over-the-Counter Drugs
1. Provide the <Drug Business License> and <Pharmacist Practice Permit/Registration Certificate>, <Drug Registration Certificate>
2. Those engaged in drug production activities need to provide the <Drug Production License>
3. Those engaged in drug retail need to provide the <Drug Business License> and also need to verify the business category and provide a <Business License> containing the specific business scope
Prescription Drugs
1. Provide the <Drug Business License> and <Pharmacist Practice Permit/Registration Certificate>, <Drug Registration Certificate>
2. Those engaged in drug production activities need to provide the <Drug Production License>
3. Those engaged in drug retail need to provide the <Drug Business License> and also need to verify the business category and provide a <Business License> containing the specific business scope
4. Enterprises engaged in online drug sales must continuously display their drug production or business license information prominently on their main business page
Traditional Chinese Medicine Pieces
Provide the <Drug Business License> and <Pharmacist Practice Permit/Registration Certificate>
Publications
Books/Newspapers/Periodicals/Books/Audio-Visual Products/Electronic Publications
Please provide the <Publication Business License>