First type medical device preparation information requirements and instructions 3
Attachment1 First types of medical device preparation requirements and description First, filing information
(1) The first type of medical device
(2) Safety risk analysis report The medical device should be prepared according to the relevant requirements of YY 0316 "Medical Device Risk Management on the Application of Medical Devices", mainly including the expected use of medical devices and judgments and hazards of safety, and estimates the risk of each hazard. Each judging hazard situation, evaluation, and decision need to be reduced risk; the implementation and verification results of risk control measures, it is necessary to reference the detection and evaluation report; an acceptability assessment of any one or more residual risks, etc. Risk management report. In vitro diagnostic reagents respond to all aspects of the product life cycle, from expected use, possible use errors, related features, known and foreseeable hazards, and risk analysis, risk assessment And the corresponding risk control, forming a risk management report.
(3) Product technical requirements Product technical requirements shall be prepared in accordance with the "Mechanical Requirements for Medical Device Products".
(4) Product inspection report The product inspection report shall be a product full-performance self-test report or entrustment inspection report, and the product that is inspected should have typical.
(5) Clinical evaluation information 1. Details Product expectations, including the functions provided by the product, and describe their applicable medical phases (such as monitoring, rehabilitation, etc.), target users and their operations should have skills / knowledge / training; Expected instruments used in combination thereof. 2. Details The product is expected to use the environment, including the location of the product, such as hospitals, medical / clinical laboratories, ambulances, families, etc., and environmental conditions that may affect their safety and effectiveness (such as temperature, humidity, Power, pressure, movement, etc.). 3. Details Products Applicable population, including information (such as adults, children or newborn), information about the standards of patients, and the parameters that need to be monitored during use, consider the factors. 4. Details of the product contraindication, if applicable, the disease or condition of the device is prohibited. 5. Alignment of clinical use of similar products listed. 6. Instructions for adverse events of similar products.
(6) Product instructions and minimum sales unit label design Medical instruments should meet corresponding regulations. Imported medical equipment products should submit the original text and Chinese translation of the instructions approved or approved by the competent government authorities. In vitro diagnostic reagent products shall be based on the relevant requirements of the "Preparation Guidance Principles" in vitro diagnostic reagent specification, and refer to the relevant technical guidelines. Imported inport diagnostic reagents should submit the original text and Chinese translation of the instructions approved or approved by the competent authorities of the overseas government.
(7) Production and Manufacturing Information An overview of the relevant situation of the production process. Passive medical equipment should clear the product production and processing technology, indicating key processes and special processes. An active medical device should provide a descriptive data for the product production process, which can be used in the form of a flowchart, an overview of the production process. In vitro diagnostic reagents should outline the main production process, including: solid phase carrier, color development system, etc., the reaction system includes sample acquisition and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration method (if needed) ), Quality control methods, etc. The actual situation of the development and production site should be summarized.
(8) Certification documents 1. The domestic filings provide: Copy of the company's business license, organizational code card copy. 2. Overseas filings provide: (1) Overseas filings enterprise qualification certificate. (2) Overseas filing registration or production address The national (region) medical device authority departments allowed product listing for certification documents. The country (region) where the filing is registered or the production address does not use the product as medical device management. certified documents. If the certificate is copied, it shall be notned by local notarization authorities. (3) The overseas filings have designated the approved agent of the agent in China, and the agent committed the book and the copy of the business license copy copy or the agency registration certificate.
(9) Compliance statement
1. Declare the relevant requirements of medical device preferences;
2. Declare that this product complies with the relevant content of the first type of medical device product catalog or the corresponding body diagnostic reagent classification subdirectory;
3. Disclaimer This product is in line with the current national standards, industry standards and provides a list of standards;
4. Declare the authenticity of the submitted filing information. Second, change filing information
(1) Change status and related certification documents The change statement describes the list of content compared to the list of information tables. If the product technology requirements are related to the requirements, the product technology requirements are required to change the content ratio table. Change the product name (in vitro diagnostic reagent is the product classification name, the following) Among them, the product name should be the same as the contents of the directory; the product description, expected use, should be the same or less directory content as the contents of the directory. The corresponding proof documents should be detailed, comprehensive and accurate.
(2) Certification documents
1. Internal filings provide: copy copy of the enterprise business license, a copy of the organization code certificate.
2. Overseas filings provide:
(1) If the change is registered in the country or the country (region) where the production address is located, the new medical device shall be issued to allow the product listing sales certificate, and the new listing document shall be submitted. If the certificate is copied, it shall be notned by local notarization authorities.
(2) The overseas filings have a copy of the approved by the agent in China, and the agent committed the book and the copy of the business license or a copy of the agency registration certificate.
(3) Compliance statement Declare to the medical
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