Medical network - July 17 provinces, autonomous regions and municipalities directly under the food and drug administration, the relevant units:
For implementing the "measures for the management of medical instrument standard" (the state food and drug supervision and administration of administration makes no. 33), to further strengthen and standardize the management of medical instrument standard system revision work, food and drug supervision administration device registration department organization revised the "medical devices standards system revision work management specification" (see annex), presently for public opinion, please feedback on August 1, 2017 through the following way:
E-mail: yys-xbs@nifdc.org.cn. Send mail, please indicated in the email subject "medical devices standards work management and revising standard opinion".
Contact: Huang Lunliang 010-88331432
Zheng jia 010-53852598
The food and drug supervision administration device registration department
On July 11, 2017
Medical devices standards system revision work management specification (draft)
The first chapter the general
Article 1 with a view to strengthening the management of medical instrument standard formulation and revision work, establish open, transparent and efficient medical equipment standard system revision operation mechanism, standardize medical devices standards formulated or revised procedures and requirements, improve the quality of medical instrument standard, according to the measures for the administration of medical devices standards such as laws and regulations, formulate this specification.
Article 2 the medical devices standards should be formulated or revised in order to ensure medical equipment is safe and effective, to protect the public health and promote the development of medical equipment industry, for the purpose of harmonious and unified, broad participation, the principle of encouraging innovation and international standards.
Article 3 this specification applies to medical apparatus and instruments of national and industry standards formulated or revised, contains the standards of medical devices, project plans, project management, drafting, authentication, for advice, technical review, check, approve and release, modify, and print, review and evaluation as well as the standards for medical devices industry rapidly and revising process of working procedures and requirements.
Article 4 the standard implement information-based management of medical equipment. Administration of state food and drug supervision and administration of medical devices standards management center (hereinafter referred to as "the tube center") is responsible for medical devices standards system revision information system (hereinafter referred to as the "information system") of the construction and maintenance.
Chapter ii standard
Article 5 of the medical devices standards projects shall practise a system of annual public solicitation. Any engaged in medical equipment development, production, management, use and supervision and management activities of the unit and individual can project proposal is put forward. Units or individuals using information systems as required to fill out the medical devices standards project proposal form (see appendix 1), submit the relevant professional medical equipment standardization technical committee (hereinafter referred to as the "JiWei will"), medical devices standards tumble technical committee (hereinafter referred to as the "points JiWei") under centralized and standardized technology units (hereinafter referred to as the "technology under centralized unit") or the pipe center.
Article 6 the tube center after receiving the project proposal, can entrust the corresponding JiWei JiWei, points or technology under centralized unit carries on the feasibility study. Involving two or more than two JiWei JiWei, points or technology under centralized unit project proposals, the standard tube center is responsible for the coordination, to determine the lead and collaboration JiWei will under centralized unit, points JiWei or technology. Might be, no relevant JiWei JiWei or technology under centralized unit project proposals, the standard tube center is responsible for the coordination, determine technology under centralized unit.
Article 7 JiWei JiWei, points or technology under centralized unit, after receipt of the project proposal shall be in accordance with the requirements of the medical devices standards plan project establishment conditions, the project proposals for further research, fully demonstrated, widely listen to the stakeholders. By will, points JiWei JiWei, project proposal subject to all the committee members review, in principle, more than two-thirds of all the committee members agreed to pass.
By technology under centralized unit under centralized, technology under centralized unit to organization representative not less than 15 units of experts and review, in principle, more than two-thirds of the representatives agree to pass. Each expert or unit with 1 votes to vote.
Review contents include project name, at least, the restraint of applicable scope, standard, the first draft unit, etc.
Article 8 the medical devices standards program planning conditions:
1. In accordance with all current national laws and regulations and the relevant provisions of the standardization work;
2. To standardize the market order, is to support and improve the social and economic benefits;
3. In accordance with the supervision and administration of medical devices and medical equipment industry development needs;
4. Meet the international standards of countries have adopted policies;
5. Promote and perfect the medical devices standards system, in principle, not with the standard of medical apparatus and instruments and has established the project cross, repeat;
6. Belong to the standard of medical devices to be mandatory industry standards plan in principle, the product should obtain medical device registration certificate shall apply.
7. Major r&d projects listed in the national industrial policy, planning, and other support for the development of regulatory and industry standards;
Article 9 the project proposal for approval, will JiWei or technology under centralized unit through the information system for online reporting as required. Points JiWei medical instrument standard plan project application, through the information system JiWei will be reported. JiWei or technology under centralized unit after approval, according to the requirements on the bid quotation tube center.
Article 10 medical equipment production enterprise, use the unit, supervisory department, the testing institutions and the relevant education scientific research institutions, social organizations, etc., you can ask the project proposal under centralized JiWei JiWei, points or technology under centralized unit is put forward as a first draft application. JiWei JiWei, points or technology under centralized units in the project application, according to the principles of openness, justice, merit, combined with the standard content, determine the first drafting unit. As the first draft unit needs to satisfy the following conditions:
1. The business scope and to technical content of the avs standards;
2. With standard project related scientific research and technical ability, in the industry representative and higher authority;
3. Familiar with national medical apparatus and instruments related policies, laws and regulations of technical personnel;
4. Familiar with standard involved in the technology development trend, production level and use requirements of both at home and abroad, the current existing problems and solutions are more understanding of technical personnel;
5. Have the ability to validate the corresponding standard.
Article 11 the tube center of JiWei will or technology under centralized unit to submit the application for medical device standard plan project summary and review. To meet the requirements of the application materials project application in information system by the standard tube center to solicit opinions from the public, for at least 15. Advice at the end of the tube center to coordinate all options, when necessary, the organization expert argumentation. For review by the project application, the tube center recommending medical instrument standard project plan, submitted to the state food and drug administration. Plan project establishment Suggestions for medical apparatus and instruments of national standard, JiWei to or technology under centralized unit in national standard system revision work management information system at the same time submit application materials.
Article 12 the state food and drug supervision and administration bureau of medical instrument standard project plan project proposal for review. Approval of medical devices standards program (hereinafter referred to as "project"), the state food and drug administration of management of the public to the society, the public after 7, and there is no objection, submit it to the competent administrative department for standardization under the state council of the national standard program approval issued according to related regulations; Industry standard project issued by the state food and drug administration bureau approval.
Article 13 the state food and drug supervision and administration bureau issued once a year in principle standards for medical devices industry projects. State food and drug supervision and management of administration can be put forward according to the regulation project plan and project approval issued standards for medical devices industry plan. Medical devices standards projects shall be announced in the information system.
The third chapter project management
Article 14 projects issued after JiWei JiWei, points or technology under centralized unit shall be planned to organize the implementation, and report to the pipe center plan according to the requirement of project implementation. The tube center conducting supervision and inspection of the implementation.
Article 15 the plan approval issued don't do adjustment in principle in the process of project implementation. Is really necessary to cancel or to the project scope, the drafting unit, standard restraint degree, under centralized change and other important items, to undertake the project plan JiWei JiWei, points or technology under centralized units to fill out the standard of medical apparatus and instruments project application form (see attachment 2), according to the requirement of the second article (4) the organization review again. To vote through the adjustment of the application, will JiWei or technology under centralized unit to undertake the project plan will adjust application form submitted the pipe center, points JiWei JiWei will adjust the application form submitted. The tube center after the audit adjustment application and puts forward some Suggestions, submit to the state food and drug supervision and administration management. The state food and drug administration of management review, after adjustment of the national standard program submitted to the competent administrative department for standardization under the state council approved according to related regulations; Industry standard plan adjustment approved by the state food and drug administration administration, and by the pipe center published in information systems. When adjusting the medical devices standards program has not been approved, to undertake the project plan JiWei JiWei, points or technology under centralized units need to be revised in accordance with the original plan to carry out the system work.
Article 16. The project must be completed by the time limit specified in the plans of the project, the completion time will be subject to the pipe center receiving date. If you can't finish, JiWei JiWei will to undertake the project plan, points or technology under centralized unit should be at least 3 months in advance to the pipe center, submit an application for extension. Such as needed to be extended by standard review failed, within a month after the end of the standard review into the pipe center, submit an application for extension. The extension and approved extension tube center audit recommendations, and relevant information will be submitted to the state food and drug administration. For the extension of the national standard program proposal, by the state food and drug administration bureau reported to the competent administrative department for standardization under the state council approved according to related regulations. For industry standards, in the information system by the standard tube center adjust industry standard project time limit.
Article 17 the approved extension project, should be completed in the application of the extended period. The same project in principle can be applied for 1 time delay, the longest delay 1 years.
Article 18 the state food and drug supervision and administration bureau every year to JiWei to or technology under centralized unit to undertake the project plan announced the planned completion. The unfinished projects total 80%, and the project without approval delay JiWei will or under centralized unit, the state food and drug supervision and administration bureau will depend on situation breaks the unit next year's programme.
Chapter iv standard drafting
Article 19 JiWei will to undertake the project plan, "or" JiWei technology under centralized unit shall promptly organize medical instrument standard drafting, the centrally responsible for medical devices standards of quality and technical content.
Article 20 medical equipment production enterprise, use the unit, supervisory department, the testing institutions and the relevant education scientific research institutions, social organizations, etc., to undertake projects of JiWei JiWei, points or technology under centralized unit as drafting unit of the application are put forward. JiWei JiWei, points or technology under centralized unit according to carry out the principle of openness, impartiality and determine to participate in the drafting unit, its composition should be representative, give full play to the supervision departments, enterprises, education, scientific research institutions, testing institutions and clinical use, the role of the social organizations and other interested parties. Project proposal unit priority as drafting unit involved in the standard system revision. Participating in drafting units need to fill out the medical devices standards drafting unit registration form (attachment 3), in JiWei to undertake the project plan to, "or" JiWei technology under centralized unit for the record. Participate in the drafting unit change, subject to JiWei JiWei will to undertake the project plan, points or technology under centralized unit and for the record.
Article 21 JiWei will to undertake the project plan, "or" JiWei technology under centralized unit organization draft recommended standards writers, and set up standard drafting group. Standard drafters shall be drafted by the unit has a rich professional knowledge and practical experience of technical personnel. Writers need to fill out the medical devices standards writers registration form (attachment 4), in JiWei to undertake the project plan will be, "or" JiWei technology under centralized unit for the record. Change in the drafters, subject to JiWei JiWei will to undertake the project plan, points or technology under centralized unit and for the record.
Article 22 the standard drafting group is responsible for drafting, and determine the remainings together, be responsible for the standard drafting specific writing, coordination, etc. Standard first remainings should meet the following conditions:
1. In principle, compulsory standards first remainings should have senior professional and technical titles or a technical position, voluntary standards first remainings to have intermediate professional and technical titles or equivalent technical position;
2. As a technical product inspection or quality work;
3. Has a certain standardization and legislation;
4. Good writing power of expression and a higher level of English;
5. Have good organization and management and coordination capacity;
6. Not seen no reason not to finish standard work tasks.
Article 23 the standard draft of extensive investigation and in-depth analysis of the working party, actively learn from relevant international standards, on the basis of fully demonstrated the content of the technology, and according to GB/T1 "guidelines for the standardization, GB/T 20000 standards such as the standardization work guide written draft draft standard specification requirements.
The fifth chapter standard authentication
Article 24 to undertake the project plan JiWei JiWei, standard or technical specification requirements under centralized unit according to the validation work organization conditional units to verify this draft standard, and the validation results were analyzed, and the conclusion are given.
Article 25 in the standard of medical devices need to test to determine the technical requirements and methods of test shall be conducted. For the entire standard does not need to test, indicate free test.
Article 26 before the test, you should plan a test program, determine the test purpose, requirement, test object, test method, test instruments, equipment, tools, used in the work place, work environment, and validation should pay attention to matters, etc., to ensure that test the reliability and accuracy.
DiShiErQiTiao to be limited by the industry or domestic situation, can't or inconvenience to test project, you should know the basis of their type on the international technical requirements using and data, and actively seek to replace the similar method verified, guarantee the scientific nature, the rationality of the standard and advanced.
Article 28 the same validation program should be carried out in different enterprises or testing institutions. Mandatory standard authentication unit should include at least a testing institution and a production enterprise.
Article 29 JiWei, JiWei or technology under centralized unit intact to verify related information. On the whole standard does not need to verify, should provide free to illustrate.
The sixth chapter for advice
Article 30 to verify through the draft standard, to undertake the project plan JiWei, JiWei or technology under centralized unit formed to medical equipment standard draft, manual and related accessories. The content of the "manual" generally include:
1. The work situation, including task sources, cooperative unit, the main work process and standard drafting units and their work, etc.;
2. The compiling principles and determine standard main content (such as technical indicators, parameters and formula, performance requirements, test methods, inspection rule, etc.) of arguments (including test, statistics), the standard, indicate contrast of old and new standard;
3. The main test (or verification) analysis, review report, technical and economic argumentation, the expected economic effect;
4. Adopt international standards and advanced foreign standards, and compared with the level of similar foreign standards and international situation, or associated with the foreign samples and prototype of test data comparison;
5. Associated with the current laws, regulations and mandatory standards;
6. Significant differences on the processing after and basis;
7. As a compulsory standards or voluntary standards of advice;
8. Suggest implement standards and measures (including measures, technical measures, such as transfer method, implementation date).
9. The current standard annulled;
10. Other issues need to be.
Article 31 JiWei will to undertake the project plan, "or" JiWei technology under centralized unit according to the requirements in the information system to provide the standard draft, manual and other accessories, to solicit opinions from the public. Regulators, production enterprises, scientific research institutions, social organizations and other stakeholders need to focus on information system in a timely and positive feedback.
Article 32 JiWei to undertake the project plan to, "or" JiWei technology under centralized unit at the same time to solicit comments from JiWei to members and related unit. If cross standard content with other departments, to solicit opinions from the relevant departments.
Article 33 for advice, need to clear comment period, usually for two months. Be advice of the unit should be responded within a prescribed period, such as no opinion also need to reply, delayed in reply, according to no objection processing. Opinions on major, indicate arguments or put forward technical arguments.
Article 34 the opinion of collected by JiWei JiWei, points or technology under centralized unit responsible for summary and induction, sorting, and feedback the standard drafting group analysis. Standard drafting team to carefully study summary opinion, handling opinions, fill out the criteria for advice summary table of medical devices (see annex 5), reported JiWei to undertake the project plan will be under centralized unit, points JiWei or technology. Handling of advice in principle there are four main conclusions: adopt, part adopt, discussion and does not accept technical review stage. For the conclusion "adopted" or "part adopt", should be adopted after the modify the content of clearly stated. For the conclusion part "adopted", "review stage discussion" or "does not accept", to explain the reasons. For major revisions of whether or not to accept, need to have good arguments.
Article 35 JiWei JiWei will to undertake the project plan, points to solicit opinions under centralized unit or technology review, if necessary, to organize all the committee members and relevant experts review to determine. If the disagreement is bigger, to undertake the project plan JiWei JiWei, points or technology under centralized unit shall organize investigation or verification again.
Article 36 if technology content have significant changes, to undertake the project plan JiWei, JiWei or technology under centralized unit again to solicit opinions from the public.
Article 37 in case of processing according to for advice, to undertake the project plan JiWei JiWei, points or technical units under centralized organization improve the standard of the working party drafting draft and related materials, the formation of standard specification, validation report and opinion SongShenGao, prepare the summary tables and related accessories processing.
Article 38 for mandatory standard project, should be more than two-thirds of all the committee members or representatives agreed, before entering the standard technical review. If failed, to undertake the project plan JiWei will be back, "or" JiWei technology under centralized unit organization draft and comment again.
Chapter 7 technical review
Article 39 JiWei will to undertake the project plan, "or" JiWei technology under centralized unit is responsible for the organization of medical instrument standard SongShenGao technical review. In the form of review meeting review and review two review forms. For compulsory standards and voluntary standards and patents in the basis of major standards and solicit opinions divided more voluntary standards SongShenGao need to review meeting. When necessary, can be in the meeting to review or letter of pre-trial to pre-trial standards, but not as the standard for approval according to the preliminary conclusion.
Article 40. Whether in the form of meeting to review or functional trial form, to undertake the project plan will JiWei JiWei or technology under centralized unit, points to send at least 10 days in advance to the information as required including standard SongShenGao, manual, comment summary treatment table and other accessories to all the committee members, or to participate in the review of the personnel and units.
Article 41 standard drafting team should be the main technical contents, the working process of the standard, for advice and handling of advice, etc., and can accurately explain the connotation of technical requirements and the standard basis. Opinions or Suggestions on all the parties shall truthfully answer accurately, and actively adopt reasonable part.
Article 42 of the review meeting, held by JiWei, points JiWei medical instrument standard project plan, JiWei JiWei, points to be responsible for the organization to submit all the committee members review, more than two-thirds, and no less than a quarter to pass. Meeting review committee when I did not attend the meeting or not entrust this unit representatives to attend the meeting, also did not say, according to the waiver. Meeting review committee (including the member representative) less than two-thirds the attendance, to reorganize the review.
Shall be borne by the technology under centralized unit of medical instrument standard project plan, technology under centralized unit organization representative according to the requirement of not less than 15 units of experts and review. Each expert or unit with 1 votes to vote, more than two-thirds, and no less than a quarter to pass. The first draft unit not to vote.
Article 43 using functional trial, to undertake the project plan will JiWei JiWei or technology under centralized unit, points must be reviewed to attend to the person or organization to send medical devices standards SongShenGao letter (appendix 6), the examination of documents and regulations reply deadline, generally not less than a month. Letter, judge not according to stipulations time voters, according to the waiver. Letter careful reply rate is less than two-thirds, to reorganize the review.
Article 44 JiWei will to undertake the project plan, JiWei or technology under centralized unit according to the meeting to review or letter of audit, form a meeting to review (letter) review summary and review meeting (letter) review conclusion table (see attachment 7), and approved by the participating members or expert review. Meeting review (letter) trial report must be reviewed truthfully report the situation, the content including time and place, to participate in the censors and unit, review, review conclusion, for preparation of SongShenGao shows the first item (2) to (10) of the review conclusion, etc. Review conclusion is divided into three kinds of situations, including unanimously, more than two-thirds majority through and not through.
Review by the article 45 of the standards, to undertake the project plan JiWei JiWei, points or technology under centralized and drafting units based on the review meeting or letter of audit opinion to modify material such as standard SongShenGao further perfect, form a draft standard approval, implementation advice (including implementation time, determine the date of implementation) etc.
Have not through the review of the standards, to undertake the project plan will JiWei or technology under centralized unit must be reviewed according to the opinion after further modification, submit review again.
Article 46 JiWei will to undertake the project plan, "or" JiWei technology under centralized unit standards approval version, proposals and related accessories, material to the tube center to submit the approval as required. National standards and industry standards of medical devices, JiWei will approval as required materials reported JiWei will through the information system. After JiWei will review by the bid quotation on pipe center.
Chapter 8 of the check, approve and release
Article 47 the tube center according to the requirements of standard procedures, approval and revising version coordination and approval materials are complete and normative review, review should be completed within 90 working days, the time required to additional information in the audit within the time limit. When necessary, can organize relevant experts for examination and approval of standard material technology demonstration. For medical devices standards need to perfect the report data, the tube center on information system to undertake projects JiWei JiWei, points or technical units under centralized audit opinions. JiWei to or technology under centralized unit to undertake the project plan in principle, within 30 working days according to the requirements of the standard tube center audit opinion shall submit relevant materials. If the examination and approval of standard draft and related approval material still is not in conformity with the relevant requirements, the pipe center will not meet the requirements of the relevant standards approval version will return JiWei, material, and its related approval JiWei or technology under centralized unit, by JiWei JiWei, points or technology under centralized unit according to the standard system revision procedure after revising perfect report again.
Article 48 the state standard of medical apparatus and instruments for approval, will JiWei or technology under centralized unit according to the requirements in the national standard system revision work management information system to complete the report. To approved standards for medical devices industry, the tube center the examination and approval of the standard draft standard publications reviewed and related materials submitted. In the review process, found that the standard text when in doubt, contact the tube by standard the publisher center.
Article 49 of the national standard work and revising the state standard of medical equipment management information system to complete the report and meet the requirements of the published standards for medical devices industry approval draft and related material, the tube center according to the requirements and procedures are submitted to the state food and drug administration of management review. Review by the administration of national standards by the state food and drug administration submitted to the competent administrative department for standardization under the state council, publish, according to the relevant provisions of the approval; Review by the industry standard approved by the state food and drug administration administration, determine the date of implementation and implementation requirements, issued in the form of announcement, when necessary to the standard implementation guidance is put forward. Medical equipment national standards, industry standards, in accordance with the relevant provisions of public, for public inspection.
Article 50 the tube center in the medical instrument standard after the release, in a timely manner to organize and guide JiWei, points JiWei and technology under centralized unit to carry out the standard of publicity and training. When necessary, the tube center to organize mandatory standard and major basic standards of publicity and training. JiWei to or technology under centralized unit standards for its focal points according to the requirement of next year propaganda, training plan and specific solutions, and bid quotation pipe on the center. The tube center in a timely manner to standard propaganda, training plans to publish to the society.
Article 51 in the implementation of standards, JiWei JiWei, points or technology under centralized units in a timely manner to carry out the standard of integrity, scientific, applicability and use to evaluate implementation, such as the purpose, and the standard implementation and feedback to the pipe center. For medical equipment, the implementation of compulsory standards, JiWei JiWei, points or technology under centralized unit should report to the pipe center compulsory standards implementation report. The tube center summary implementation and according to the claim submitted to the state food and drug administration of the management.
Article 52 the tube center is responsible for JiWei JiWei, points or the implementation of the technology under centralized unit medical equipment standard management and examination of developing circumstance of the evaluation work. When necessary, the tube center can organize the relevant units, experts, mandatory standard of medical devices, major basic standards to evaluate the implementation of the.
Chapter 9 modification and correction
, after the article 53 medical devices standards published by individual technical content affect the standards need to be modified, or increase or decrease the content of the original standard, shall adopt the standard modified single mode changes.
Article 54 medical devices standards, under centralized JiWei JiWei, points or technology under centralized unit should be carried out according to the process of medical device standards formulated or revised standards change single draft, for advice, technical review and approval. Medical devices standards change single comment time can be shorten appropriately.
Article 55 the tube center will approved medical devices standards change list and related application materials submitted to the state food and drug administration of management review. Upon examination by the medical equipment national standards change single and relevant approval, by the state food and drug administration bureau reported to the competent administrative department for standardization under the state council, the competent administrative department for standardization under the state council for examination and approval, and release. Standards for medical devices industry change single, managed by the state food and drug administration approved and issued.
Article 56 of the medical devices standards after publishing, if found wrong character standard text, or punctuation errors, and does not involve the use of technical indicators or change or modify the content of the errata understand ambiguity, won't produce standard after by centrally JiWei will under centralized unit, points JiWei or technology will to print the contents of the report publishing department and send the pipe center. Standard to print the publisher has been verified, errata or errata, be corrected in the standard printing again, at the same time, published by the state food and drug supervision and administration bureau standard text and publications.
Chapter ten review and evaluation
Article 57 the standard after implementation of medical equipment, to ensure its effectiveness, applicability and practical, improve standard technology and quality level, JiWei, points JiWei technology under centralized unit should be according to the medical apparatus and instruments or related science and technology development, industrial development, tracking and evaluation need regulation and standards organization review. The review cycle does not more than five years. Review can use meeting, review or letter standard review procedures and requirements to the provisions of article 5 of the regulations, form the review conclusion.
Standard review article 58, JiWei JiWei or technology under centralized unit, points to form the review report, report content including second review introductions, review procedures, handling opinions, conclusions, and will bid quotation on the standard review material tube center. To submit the materials including review report to submit the documents, standard, standard review project summary and review conclusion table (see annex 8).
Article 59 the review conclusion after approval by the standard tube center, submitted to the state food and drug administration of management review. Medical equipment national standard review conclusion submitted to the competent administrative department for standardization under the state council for approval; Standards for medical devices industry review conclusion managed by the state food and drug administration review and approval.
Article 60 medical devices standards review conclusion is divided into continue to be valid, revised or abolished. According to the review conclusion, respectively according to the following situations:
1. Confirm the medical devices standards continue to be valid, maintain the original standard number and title. Continue to effective medical device industry standards by the state food and drug administration bureau identification in the standard system in public.
2. Revision of the medical devices standards, under centralized JiWei will or technology under centralized unit should be in accordance with the project requirement for revision, and included in the plan after revision, or modified by modifying the list.
3. Confirm the abolition of medical instrument standard, national standard according to the provisions of the competent administrative department for standardization under the state council shall be repealed, industry standards by the state food and drug administration bureau shall be abolished and published after approval.
Chapter 11 industry standard system revision program quickly
Article sixty-one for medical device regulatory need amending the industry standard, can be used to quickly process.
Article sixty-two according to the regulation need situation, the tube center JiWei or technology under centralized organization related technical committee, the points after they discussed project Suggestions, submitted to the state food and drug administration. Issued by the state administration of food and drug supervision and management of the project plan.
Article sixty-three after a plan task release, JiWei will to undertake the project plan, points to speed up the drafting of JiWei or technology under centralized unit, comment and technical review, and finish the report on time. For advice time in principle can be reduced to 10 working days.
Article sixty-four the tube center in ten working days to complete audit and report to the state food and drug administration. State food and drug supervision and management of the administration of examination and approval, release within 10 working days.
Chapter 12 is attached
Article sixty-five JiWei JiWei, points or under centralized unit should be in accordance with the "standard file management method" and other relevant provisions save the standard system revision process documents, including project proposal, drafters registration form, verify the original documents, meeting minutes, standard document for approval voting process. Archive material need to ensure that reliable and traceable.
Article sixty-six of this code by the state food and drug administration bureau is responsible for the interpretation.
Article sixty-seven the standards come into force from the date of release. The state drug administration issued on April 6, 2007, the medical device industry standard system revision work specification (try out) "(trial) shall be repealed simultaneously.
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