I. Introduction.
As an important tool to ensure public health and safety, the filing process of sterilized instruments is very important. In order to ensure the safety and effectiveness of sterilized equipment, the relevant filing department requires the applicant to submit a series of materials. In this article, we will introduce in detail the list of materials and requirements required for the filing of disinfection equipment to help applicants successfully complete the filing process.
2. List of materials for the filing of disinfection equipment.
2.1. Introduction to the basic situation of the enterprise: including the name, address, legal representative and other information of the enterprise to prove the legitimacy and basic information of the enterprise.
2.2. Product manual: The structure, function, method of use, scope of application, precautions, etc. of the sterilized instrument should be described in detail, so that the filing department can understand the performance and use of the product.
2.3. Technical parameters of sterilized instruments: including the main technical parameters of sterilized instruments, such as power, voltage, current, frequency, etc., to ensure that the products meet the relevant standards and requirements.
2.4. Disinfection effect test report: The disinfection effect test report issued by an authoritative organization should be provided to prove that the disinfection effect of the sterilized instrument meets the relevant standards.
2.5. Safety assessment report: The safety of sterilized equipment should be evaluated, including electrical safety, chemical safety, biological safety, etc., to ensure that the product will not cause harm to personnel and the environment during use.
2.6 Clinical trial report (if any): If the sterilized device needs to be clinically conducted, the clinical trial report issued by the medical institution should be provided to prove the effectiveness and safety of the product in practical application.
2.7. Quality management system documents: The quality management system documents of the enterprise should be provided, including quality manuals, program documents, work instructions, etc., to prove that the enterprise has a sound quality management system.
2.8. Other relevant supporting documents: Depending on the specific situation, other relevant supporting documents may be required, such as product patent certificates, environmental protection certification certificates, etc.
3. Requirements for submission of materials.
3.1. All submitted materials should be true, accurate and complete, and there should be no false or misleading content.
3.2. The materials should be organized in the order of the list and packed in folders or file bags for the inspection of the filing department.
3.3 The materials should be printed or copied on A4 paper with clear handwriting and should not be altered.
3.4. All submitted materials should be stamped with the official seal of the enterprise and signed and confirmed by the legal representative.
3.5. If necessary, the filing department may verify the submitted materials, and the enterprise should actively cooperate.
4. Introduction to the filing process.
4.1. The applicant shall prepare all filing materials as required.
4.2. Submit the materials to the acceptance window designated by the filing department.
4.3. The regulatory authority will conduct a preliminary review of the submitted materials, and if the materials are incomplete or do not meet the requirements, the applicant will be notified to supplement or amend.
4.4. After the preliminary examination is passed, the filing department will conduct a technical assessment and safety assessment of the sterilized equipment.
4.5. After the technical assessment and safety assessment are passed, the filing department will issue a record certificate for disinfection equipment.
4.6. After the applicant obtains the record certificate, the formal production and sale of disinfection equipment can be made.
V. Conclusion. The filing of disinfection equipment is an important part of ensuring public health and safety, and applicants should prepare and submit materials in strict accordance with the filing requirements. Through the introduction of this article, I believe that applicants have a clearer understanding of the materials required for the filing of disinfection equipment. Hopefully, this article will help applicants successfully complete the filing process.