1. To apply for "Class I medical device product registration" in Changchun City, you need to bring the following materials to apply:

1. In general, you need to provide: Safety risk analysis report (paper and electronic version: 1 original; 0 copy; 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. Product registration materials should be submitted together with the electronic version if there are no special instructions. The seal shall be signed by the filing person. “Signature” refers to: the filing person’s seal, or the signature of the legal representative or person in charge plus the company’s seal. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3. Medical devices should be prepared in accordance with the relevant requirements of YY 0316 "Application of Medical Device Risk Management to Medical Devices", mainly including the determination of the intended use and safety-related characteristics of the medical device, the determination of hazards, and the estimation of the risks of each hazardous situation. ; For each identified hazardous situation, evaluate and decide whether risk reduction is needed; the implementation and verification results of risk control measures, and reference to testing and evaluation reports when necessary; the acceptability assessment of any one or more residual risks, etc. , form a risk management report. In vitro diagnostic reagents should deal with all aspects of the product life cycle, including determination of intended uses, possible use errors, safety-related characteristics, known and foreseeable hazards, and estimation of patient risks. Based on risk analysis, risk evaluation and corresponding risk control, a risk management report is formed)

2. General requirements: product technical requirements (paper and electronic version: 1 original; copy). 0 copies; 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration materials should be signed and sealed by the filing person. "Signature and seal" refers to: the seal of the filing person, or the signature of the legal representative or person in charge plus the seal of the company. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3. Product technical requirements should be in accordance with the "Medical Treatment". "Guiding Principles for Writing Technical Requirements for Device Products")

3. Generally, product inspection reports (paper and electronic versions: 1 original; 0 copies; 1. Filing materials should be complete. , clear, printed and bound on A4 paper, and the copy shall be stamped with the official seal and submitted together with the electronic version. 2. If there is no special instructions in the product registration information, the "signature" means the signature of the filing person. Seal, or the signature of the legal representative or person in charge plus the seal of the company. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3. The product inspection report should be a product full performance self-inspection report or a commissioned inspection report. The product should be typical. )

4. In general, it is necessary to provide: product instructions and minimum sales unit label design sample (paper and electronic versions: 1 original; 0 copies; 1. Filing The materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there is no special instructions for the product registration information, it should be signed and sealed by the filing person. "Signature and seal" refers to: the seal of the filing party, or the signature of its legal representative or person in charge plus the seal of the enterprise. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3. Medical devices should comply with the requirements of the "Medical Device Instructions and Label Management Regulations". 4. In vitro diagnostic reagent products should comply with the relevant requirements of the "Guiding Principles for Writing Instructions for In Vitro Diagnostic Reagents" and refer to relevant technical guidelines to prepare product instructions. )

5. In general, you need to provide: Class I medical device registration form (electronic version: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, The copy shall be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration information shall be signed by the filing person or the person in charge. The registration form must be signed and stamped by the company. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3. Complete the filing form and fill it out in strict accordance with the "Form Filling Instructions", and attach the electronic file of the filing form and the information contained therein. Excel electronic document of the contents of the filing form). )

6. In general, it is necessary to provide: Declaration of conformity (paper and electronic versions: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and copied The document shall be stamped with the official seal and submitted together with the electronic version. 2. If there is no special instructions in the product registration information, it shall be signed and sealed by the person filing the document.

"Signature and seal" refers to: the seal of the filing party, or the signature of its legal representative or person in charge plus the seal of the enterprise. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3.1 Declare that this product complies with the relevant requirements for medical device registration; 3.2 Declare that this product complies with the relevant contents of the Category I medical device product catalog or the corresponding in vitro diagnostic reagent classification subcatalog; 3.3 Declare that this product complies with current national standards and industry standards and provide a list of compliance with the standards ;3.4. Declare the authenticity of the filing materials submitted. )

7. In general, it is necessary to provide: clinical evaluation data (paper and electronic versions: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and copied The document shall be stamped with the official seal and submitted together with the electronic version. 2. If there is no special instructions, the product registration information shall be signed by the filing person or his legal representative or person in charge. Signature and company seal. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. 3.1 Describe the intended use of the product, including the functions provided by the product, and describe its applicable medical stage (such as post-treatment monitoring, Rehabilitation, etc.), the target users and the skills/knowledge/training they should have to operate the product; the devices expected to be used in combination with it 3.2 Detail the intended use environment of the product, including the locations where the product is expected to be used such as hospitals, medical/clinical laboratories. , ambulances, homes, etc., as well as environmental conditions that may affect its safety and effectiveness (such as temperature, humidity, power, pressure, movement, etc.) 3.3 Detail the product’s applicable population, including information on the target patient population (such as adults). , children or neonates), information on patient selection criteria, as well as parameters to be monitored and factors to be considered during use. 3.4 Detailed description of product contraindications and, if applicable, diseases or conditions in which use of the device is prohibited. 3.5 Already. Comparative description of clinical use of similar products on the market 3.6. Description of adverse events of similar products)

8. General requirements: Enterprise business license (original and copy) (paper: 0 original; copy. 1 copy; 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration materials should be signed and sealed by the filing person. "Signature and seal" means: the seal of the filing person, or the signature of the legal representative or person in charge plus the seal of the company. The seal must be the official seal of the filing person, and the special seal for registration is not allowed)

9. .In general, you need to provide: Catalog of application materials (paper and electronic versions: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and merged with the electronic version. 2. If there are no special instructions in the product registration materials, the "signature" means the seal of the filing party, or the signature of the legal representative or person in charge and the seal of the company. It must be the official seal of the filing person, and the special seal for registration is not allowed. 3. The information catalog includes the first-level and second-level titles of the entire application materials, and the volume and page number of each item are stated in a table)

10. In general, you need to provide: production and manufacturing information (paper and electronic versions: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and combined with the electronic version. Submit. 2. If there are no special instructions in the product registration materials, "signature" means: the signature of the filing person, or the signature of the legal representative or person in charge plus the seal of the company. It is the official seal of the filing person, and the special seal for registration is not allowed. 3. An overview of the relevant circumstances of the production process. For passive medical devices, the product production and processing technology should be clearly defined, and key processes and special processes should be noted. Active medical devices should provide descriptive information on the production process of the product, which can be in the form of a flow chart, which is an overview of the production process. In vitro diagnostic reagents should outline the main production process, including: description and determination basis of solid phase carrier, color development system, etc. The reaction system includes sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration method (if necessary ), quality control methods, etc. The actual situation of the development and production sites should be summarized. )

11. In general, you need to provide: Power of attorney (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and copied The document shall be stamped with the official seal and submitted together with the electronic version. 2. If there is no special instructions in the product registration information, it shall be signed and sealed by the person filing the document.

"Signature and seal" refers to: the seal of the filing party, or the signature of its legal representative or person in charge plus the seal of the enterprise. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. )

2. Charges for this matter:

No charge

3. Processing time limit

1 working day

4. Application address

Note: If the government service center or public service center in the administrative area where your registered place of residence is located is not among the outlets listed, please first call the government service center or the public service center of your registered place of residence. Public Service Center.

Network name: Third floor of Nong'an County Government Service Center Branch address: No. 1616, Debia Street, east of Longfu Square, Nong'an County, Changchun City, Jilin Province Telephone: 0431-83279001 Office hours: Winter: 8:30 -16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Outlet name: Jingyue Development Zone Government Service Center Outlet address: 6666 Ecological Street, Jingyue District, Changchun City Branch telephone number: 0431-85213531 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Outlet name: Shuangyang District Government Affairs Service center outlet address: South outlet of Dinglu Plaza, Shuangyang District, Changchun City Tel: 0431-84285756 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays)

Network name: Jiutai District Government Service Center Branch address: Minsheng Building, the intersection of Changtong Road and Fulin Street, Jiutai District, Changchun City, Jilin Province Branch phone number: 0431-81367322 Office hours: Winter: 8:30- 16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Network name: Yushu Municipal Affairs Service Center Branch address: Yushu Municipal Affairs Service Center (southeast of Yushu Municipal Government) Branch phone number: 0431-83835541 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Outlet name: Dehui City Affairs Service center address: Dehui City, 100 meters westbound from the intersection of Dexing Road and Huixin Road. Branch phone number: 0431-87000815 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Sunday Five (except statutory holidays)

Outlet name: High-tech Zone Government Service Center Outlet address: Changchun High-tech Zone Mass Entrepreneurship Center Outlet phone: 0431-82532700 Office hours: Winter: 8:30-16:00 Summer : 8:30-16:30 Monday to Friday (except statutory holidays)

Outlet name: Chaoyang District Government Service Center Outlet address: No. 1149 Yan'an Street, Changchun City, Jilin Province Outlet phone: 0431-85090718 Office Time: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Outlet name: Erdao District Government Service Center Outlet address: Changchun City No. 799 Huigong Road, the intersection of Huigong Road and Guangde Street, Erdao District Tel: 0431-89177966 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (statutory Except holidays)

Outlet name: Changchun Municipal Affairs Service Center Outlet address: No. 3177 Puyang Street, Changchun City Outlet phone number: 0431-88779017 Office hours: Winter: 8:30-16:00 Summer: 8: 30-16:30 Monday to Friday (except legal holidays)

Outlet name: Nanguan District Government Service Center Outlet address: East branch of Nanguan Traffic Police Team, No. 399 Jiayuan Road, Nanguan District, Changchun City Tel: 0431-89682700 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Outlet name: Kuancheng District Government Service Center Branch address: No. 228, Fucheng Road, Kuancheng District, Changchun City Branch phone: 0431-89991639 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays)

Outlet name: Lianhuashan District Government Service Center Outlet address: No. 1, Wujiu Road, Quanyan Town, Lianhuashan Resort

Branch phone number: 0431-81336520 Office hours: Winter: 9:00-16:30 Summer: 9:00-17:00 Monday to Friday (except legal holidays)

Outlet name: Qikai District Government Affairs Service center address: No. 7766 Dongfeng Street, Qikai District, Changchun City Qikai District Management Committee branch phone number: 0431-81501237 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Sunday Five (except legal holidays)

Outlet name: Green Park Government Service Center Outlet address: No. 6665, Xi'an Road, Changchun City, Jilin Province Outlet phone: 0431-89625000 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays)

Outlet name: Third floor of Nong'an County Government Service Center Outlet address: East side of Longfu Square, Nong'an County, Changchun City, Jilin Province Phone number of the branch at No. 1616 Biao Street: 0431-83279001 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays)