1. basic project situation

(i) project name: research and development of digital pathology and artificial intelligence-assisted diagnostic equipment

(ii) project location: jinfeng laboratory

(iii) purchase method: inquiry

(iv) procurement content:

tutoring the project results of the research group in accordance with the requirements of the medical device gmp system and the registration and application requirements of the class ii medical device in chongqing.

1. product inspection

assist party a in preparing relevant inspection materials in accordance with the inspection requirements of the inspection institute. the specific service content is as follows:

(1) product technical requirements;

(2) instructions for use;

(3) risk management report;

2. system tutoring

party b will in accordance with the requirements of gb/t 19001-2016 idt iso 9001:2015 "quality management system requirements", gb/t 42061-2022 idt iso 13485:2016 "medical device quality management system used for regulations" and "guiding principles for independent software on-site inspection of quality management specifications for medical device production quality management specifications", to ensure that party a's quality management system operates normally and passes the on-site verification of the registration system of the contract project.

3. registration and declaration

party b provides party a with complete registration application information in accordance with the requirements of the "guiding principles for the technical review of medical device software registration", "management measures for the registration and filing of medical devices" and announcement no. 121.

2. supplier qualification requirements

(1) qualification conditions for article 22 of the government procurement law of the people's republic of china:

1. have the ability to bear civil liability independently;

2. have good business reputation and a sound financial accounting system;

3. have the equipment and professional technical capabilities necessary to perform the contract;

4. have a good record of paying taxes and social security funds in accordance with the law;

5. within three years before participating in government procurement activities, there were no major illegal records in business activities;

6. other conditions stipulated by laws and administrative regulations.

note: article 1 requires a business license, organization code certificate, tax registration certificate or legal person certificate of public institution. only a business license is provided if the three certificates are integrated; please refer to the statement for details in paragraphs 2-6.

(ii) have experience in gmp system guidance and product registration application:

1. be able to guide and establish a quality management system in accordance with the requirements of gb/t 19001-2016 idt iso 9001:2015 "quality management system requirements", gb/t 42061-2022 idt iso 13485:2016 "medical device quality management system used for regulatory requirements" and "guiding principles for independent software on-site inspection of quality management specifications for medical devices production" to ensure that the quality management system operates normally and passes the on-site verification of the project registration system;

2. provide complete registration application materials in accordance with the requirements of the "guiding principles for technical review of medical device software registration", "management measures for registration and filing of medical devices" and announcement no. 121.

3. inquiry schedule

(i) inquiry release time: 17:00 on september 1, 2025

(2) inquiry deadline: 17:00 on september 4, 2025

the supplier should send the quotation list and related attachments (need to be stamped with official seal and scanned in color) to the contact email address 1360191768@qq.com before the inquiry deadline. those who have not quoted before the inquiry deadline will be deemed to have automatically given up.

related attachments are as follows:

1. copy of business license or proof documents of other organizational entities;

2. certificate of qualification of legal representative (appendix 1);

3. authorization letter of the legal representative (appendix 2);

4. statement (appendix 3);

5. quotation list;

6. others.

4. quotation list

5. contact information

contact person and contact information:

contact address:

attachment.docx