Witness the record, the test personnel signature must be a person with a tester's certificate?
Strictly speaking, it must be a certified person and it must be a person of record.
All tests performed by your testing department require you to be certified. Whether it is sampling or other, check not strict even if, check strictly you sign this piece is a problem, people can say you do not have the appropriate documents, do not have the qualifications of sampling. And sampling is the most important part of the test, directly affecting the accuracy of your results. To put it a little less seriously, we have been asked to do so here.
Medical device filing regulations?
Chapter I General Provisions
Article I In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations.
The second in the Chinese people *** and the State engaged in the development of medical devices, production, operation, use of activities and their supervision and management shall comply with these regulations.
Article 3 the state council food and drug administration is responsible for the supervision and management of the national medical devices. The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug administration department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of national medical device industry planning and policy.
Article 4 of the state of medical devices in accordance with the degree of risk to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The food and drug administration department under the state council is responsible for formulating the classification rules and classification directory of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification directory. The formulation and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and refer to the international medical device classification practice. Classification catalog of medical devices shall be published to the community.
Article V The development of medical devices shall follow the principles of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, play the role of market mechanism, promote the popularization and application of new technology of medical devices, and promote the development of medical device industry.
Article VI of the medical device products should be consistent with the mandatory national standards for medical devices; there is no mandatory national standards, should be consistent with the mandatory industry standards for medical devices.
Disposable medical device directory by the State Council food and drug supervision and management department in conjunction with the State Council department in charge of health planning to develop, adjust and publish. Repeated use can ensure the safety and effectiveness of medical devices, not included in the single-use medical device catalog. Repeated use due to design, production process, sterilization technology and other improvements can ensure the safety and effectiveness of medical devices, should be adjusted out of the directory of single-use medical devices.
Article VII of the medical device industry organizations should strengthen industry self-discipline, promote the construction of integrity system, supervise enterprises in accordance with the law to carry out production and business activities, and guide enterprises to be honest and trustworthy.
Chapter II Medical Device Product Registration and Filing
Article VIII of the first class of medical devices to implement product filing management, the second and third class of medical devices to implement product registration management.
Article IX Class I medical device product filing and application for Class II, Class III medical device product registration, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product specifications and labeling samples;
(F) and product development, production-related quality management system documents;
(VII) to prove that the product is safe, effective and other information required.
Applicants for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted.
Article X of the first class of medical device products for the record, by the filer to the municipal people's government of the location of the food and drug supervision and management department to submit the record information. Among them, the product inspection report can be the filer's self-inspection report; clinical evaluation information does not include clinical trial report, can be through the literature, clinical use of similar products to obtain data to prove that the medical device is safe and effective information.
To export Class I medical devices to the territory of China's foreign manufacturers, by its representative body established in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the filing information and the filer's country (region) competent authorities to authorize the sale of the medical device on the market documents.
Filing information contained in the matter of change, should be filed to the original record department to change the record.
Article XI of the application for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Food and Drug Administration.
To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up by its representative body in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration and the registration of the applicant's country (region) competent authorities to authorize the sale of the medical devices on the market documents.
The second class, the third class of medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.
Article XII of the food and drug supervision and management department shall accept applications for registration within three working days from the date of acceptance of the application for registration information will be forwarded to the technical review body. Technical review body shall complete the technical review to the food and drug supervision and management department to submit the review.
Article XIII of the food and drug supervision and management department shall accept applications for registration within 20 working days from the date of receipt of the review comments to make a decision. To meet the safety and efficacy requirements, granted registration and issue a medical device registration certificate; does not meet the requirements, not registered and a written explanation of the reasons.
The State Council Food and Drug Administration in the organization of the technical review of imported medical devices that it is necessary to verify the quality management system, should be organized to check the quality management system technical institutions to carry out quality management system verification.
Article XIV has been registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, methods of use and other substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for a change in the registration procedures; non-substantive changes that do not affect the safety and effectiveness of the medical device, the changes should be made to the original registration department for the record. To the original registration department for the record.
Article XV of the medical device registration certificate is valid for five years. The expiration of the validity of the need to renew the registration, should be valid for six months before the expiration of the original registration department to apply for renewal of registration.
Except for the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiration of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
One of the following circumstances, not renewed:
(a) the registrant did not apply for renewal of registration within the specified period;
(b) the mandatory standards for medical devices have been revised, apply for the renewal of registration of medical devices can not meet the new requirements;
(c) used for the treatment of rare diseases and to deal with public **** health emergencies Urgent need for medical devices, medical device registration certificate is not completed within the specified period of time the matters set out.
Article XVI of the newly developed medical devices have not been included in the classification of the catalog, the applicant can apply directly for product registration in accordance with the provisions of this regulation relating to the registration of Class III medical devices, but also based on the classification rules to determine the product category and apply to the State Council food and drug supervision and management department of the category confirmed in accordance with the provisions of this regulation to apply for registration or product filing.
Directly apply for registration of Class III medical device products, the State Council Food and Drug Administration shall determine the category in accordance with the degree of risk, the registration of medical devices granted in a timely manner into the classification catalog. Application for category confirmation, the State Council Food and Drug Administration shall accept the application from the date of 20 working days to determine the category of the medical device and inform the applicant.
Article 17 of the first class of medical device products for the record, do not need to conduct clinical trials. Application for registration of Class II, Class III medical device products, should be clinical trials; however, one of the following circumstances, can be exempted from clinical trials:
(a) the working mechanism is clear, the design is finalized, the production process is mature, and has been listed in the same variety of medical devices for many years of clinical application and no record of serious adverse events, do not change the routine use;
(b) through non-clinical evaluation can prove that the medical device is safe and secure. Clinical evaluation can prove that the medical device is safe and effective;
(C) through the clinical trials of the same variety of medical devices or clinical use of the data obtained by analyzing and evaluating, can prove that the medical device is safe and effective.
Exempted from clinical trials of medical devices catalog by the State Council Food and Drug Administration to develop, adjust and publish.
Article 18 to carry out clinical trials of medical devices, should be in accordance with the requirements of the quality management standard for clinical trials of medical devices, clinical trials in qualified institutions, and to the clinical trial of the proposed location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department for the record. Accept the record of clinical trials of food and drug supervision and management department shall inform the clinical trial organization where the same level of food and drug supervision and management department and the competent department of health and family planning.
Medical device clinical trial organization accreditation conditions and clinical trial quality management standards, by the state council food and drug supervision and management department in conjunction with the state council department in charge of health planning to develop and publish; medical device clinical trial organization by the state council department of food and drug supervision and management department in conjunction with the state council department in charge of health planning to identify and publish.
Article 19 of the third class of medical devices for clinical trials on human beings with a higher risk, shall be approved by the State Council food and drug administration department. Clinical trials on the human body has a higher risk of third-class medical device directory by the food and drug administration department of the State Council to develop, adjust and publish.
The food and drug administration of the State Council for approval of clinical trials, should be to undertake clinical trials of medical devices, equipment, professionals and other conditions of the institution, the risk level of the medical device, the clinical trial implementation plan, clinical benefit and risk of comparative analysis of the report for a comprehensive analysis. Permitted to carry out clinical trials, should be informed of the clinical trial proponent and the clinical trial organization where the provincial, autonomous regions and municipalities directly under the Central People's Government of the food and drug supervision and management department and the competent department of health and family planning.
Project acceptance record management regulations?
Article 1 in order to strengthen the management of the quality of housing construction projects and municipal infrastructure projects, according to the "Construction Engineering Quality Management Regulations", the formulation of these measures.
The second in the Chinese people *** and the country's new construction, expansion, alteration of all types of housing construction projects and municipal infrastructure projects for the record of the completion of acceptance, the application of these measures.
Article 3 of the State Council administrative department in charge of construction is responsible for the national housing construction projects and municipal infrastructure projects (hereinafter collectively referred to as the project) of the completion of the acceptance of the record management.
Local people's governments at or above the county level is responsible for the construction of the administrative area of the completion of the acceptance of the project for the record management.
Article 4 of the construction unit shall, within 15 days from the date of acceptance of the completion of the project, in accordance with the provisions of these measures, to the construction of the local people's government at or above the county level of the local people's government (hereinafter referred to as the filing authority) for the record.
Article 5 of the construction unit for the record of acceptance of completion of the project shall submit the following documents:
(a) the record of acceptance of completion of the project form;
(b) the report of acceptance of completion of the project. Completion acceptance report shall include the date of construction report, construction permit number, construction plan design document review comments, survey, design, construction, engineering supervision and other units were signed by the quality of qualified documents and acceptance of the original documents signed by the acceptance of acceptance, municipal infrastructure, the relevant quality testing and functional test information and the record-keeping authority believes that the need to provide the relevant information;
(iii) Laws and administrative regulations shall be issued by the planning, public security, fire prevention, environmental protection and other departments of the recognition of the document or permit the use of the document;
(d) construction unit signed by the warranty of quality of the project;
(e) regulations, rules and regulations provide that must be provided to the other documents.
Commercial housing should also be submitted to the "Residential Quality Warranty" and "Residential Use Instructions".
Article VI of the record authorities received the construction unit to submit the completion of the acceptance of the record documents, verify that the documents are complete, should be in the project completion of the acceptance of the record form on the signature of the receipt of documents.
Project completion and acceptance of the record form in duplicate, a copy of the construction unit to save, a copy of the filing authority to stay on file.
Article VII of the project quality supervision organization shall, within five days of the date of completion and acceptance of the project, to the record-keeping organ to submit the project quality supervision report.
Article VIII of the record-keeping authority found that the construction unit in the completion of the acceptance process in violation of state regulations on quality management of construction works, shall be received in the completion of the acceptance of the record documents within 15 days, ordered to stop the use of re-organization of the completion of the acceptance.
Article IX construction unit in the completion of the project acceptance within 15 days of the date of completion of the project did not handle the acceptance of the record, the record-keeping authority ordered to make corrections within a certain period of time, impose a fine of 200,000 yuan or more than 300,000 yuan.
The tenth construction unit will be filing authority decided to re-organize the completion and acceptance of the project, before re-organizing the completion and acceptance of the project, unauthorized use, the record-keeping authority ordered to stop the use of more than 2% of the contract price of the project, a fine of 4% or less.
Article XI of the construction unit using false documents for the record of completion and acceptance of the project, the completion and acceptance of the project is invalid, the record-keeping authority ordered to stop using the re-organization of the completion and acceptance of the project, impose a fine of 200,000 yuan or more than 500,000 yuan; constitutes a crime, shall be investigated for criminal responsibility.
Article XII of the record organ decided to reorganize the completion inspection and ordered to stop using the project, the construction unit has been put into use before the record or the construction unit without authorization to continue to use the loss caused by the user, by the construction unit shall bear the responsibility for compensation.
Article XIII of the completion and acceptance of the complete record of documents, the record organ and its staff do not handle the record procedures, the relevant authorities shall order correction, the directly responsible personnel to give administrative sanctions.
Article XIV of the rescue and disaster relief projects, temporary housing construction projects and farmers to build their own low-rise residential projects, does not apply to this approach.
Article XV of the military housing construction project completion acceptance record, in accordance with the relevant provisions of the Central Military Commission.
Article XVI of the people's governments of provinces, autonomous regions and municipalities directly under the Central People's Government of the construction administrative department can be based on these measures to formulate implementation details.
Article XVII of these Measures shall be interpreted by the competent department for construction administration of the State Council.
Article 18 of these measures shall come into force on the date of publication.
What is the meaning of BE filing?
BE test filing refers to the whole process that the applicant for the filing of BE test for chemical generics carries out and completes the BE test on its own after submitting the filing information in accordance with the requirements on the information platform designated by the State Food and Drug Administration in the process of the research of chemical generics and obtaining the filing number.
Generic drugs are alternative drugs with the same active ingredients, dosage forms, routes of administration and therapeutic effects as the generic drug, which have important economic and social benefits such as lowering medical expenditures, improving drug accessibility, and upgrading the level of medical services.