I. Amendment of the Measures

2002，The former State Drug Administration issued the implementation of the "Management Measures for the Standards for Medical Devices (Trial)" (Original Order No. 31)，Standardization management of medical devices in my country、The revision of the standard system and the implementation of the promotion standard played a positive role in promoting。
With the continuous development of the standardization of medical equipment，Former State Drug Administration established a full -time institution for standard management of medical device standards in 2010，further strengthened the organizational management of medical device standards，The medical device standard management system has changed。
June 2014，The State Council promulgated the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) (hereinafter referred to as the "Regulations")，Cancel the registered product standard，Clarify the legal status of product technical requirements，Change the national standard of the original medical device、Three -level standard system composed of industry standards and registered product standards，The standard system of the medical device has changed.。
In 2015, the State Council issued the "Opinions on Reforming the Approval System for Reforming the Medical Device Review and Approval" (Guo Fa [2015] No. 44)，Set clear requirements for the standard work of medical equipment。
At the same time，March 2015，The State Council issued the "Reform Plan for Deepening Standardization Work"。2016，The State Council's Legal Affairs Office publicly solicited opinions on the "Standardization Law of the People's Republic of China (Revised Draft Consultation Draft)"，China's standardization system and management system faces major adjustments，National new standard system is gradually set up，The new standardization pattern is forming。
Further implementation of the State Council ’s“ Reform Plan for Deepening Standardization Work ”and“ Opinions on Reforming the Approval System for Reforming Drugs and Medical Devices ”(Guofa [2015] No. 44)，New needs to meet medical device supervision and industrial development，New requirements for the development of medical stake betting appdevice standards，The General Administration organized the revision of the "Administrative Measures for the Standards for Medical Device"。

2. Regarding the overall revision

"Measures" increased from the original 24 to 36，According to the new version of the "Regulations" and "Administrative Measures for Registration of Medical Device"，Deleted the entire chapter of the "Registered Product Standard" in the original "Registered Product Standard" and the content of the "Registered Product Standards for Medical Device"，Added related content of product technical requirements，Clarified product technical requirements and compulsory standards、Relationship between recommendation standards。A perfect content of the "Standard Implementation and Supervision" chapter，Further refine the standard management responsibilities and standard system revision work procedures，Emphasizing the content of standard openness and standard tracking evaluation。

3, definition of medical equipment standards

"Measures" clarify the definition of medical device standards，refers，Published in accordance with the law according to law，Development of medical devices、Production、Business、Use、Unified technical requirements followed in activities such as supervision and management。

4. Regarding medical device standard classification

"Measures" further clarified the national standard of medical device、Industry standards and compulsory standards、Recommended standards。Mandatory standards are technical requirements involving personal health and life safety，Medical Device Mandatory Standards include compulsory national standards and compulsory industry standards; recommendation standards to meet the foundation、Support for compulsory standards、Technical requirements for leading role in the medical device industry。Recommended standards for medical devices include medical device recommendation national standards and recommendation industry standards。

5. About standard management responsibilities

"Measures" clarify the State Food and Drug Administration、Standard Management Center of the State Administration of Food and Drug Administration (hereinafter referred to as medical device standard management center)、Medical Device Standardization Technical Committee、Medical Devices Standardized Technology Duty Unit、Local Food and Drug Supervision and Management Department、Standardized responsibilities and work content of the relevant units and other related parties。
Article 10 Clarify the responsibilities of the State Food and Drug Administration in standard management，Responsible for organizing and implementing the relevant laws of medical device standard management、Regulations，Formulate a standard management system for medical device standards; organize the formulation of medical device standard planning，Prepare the standard system revision annual work plan; organize a revision of the standard system system in accordance with the law，Release the medical device industry standard and guidance in accordance with the law、Supervision medical device standard management work。
Article Stake Sports Betting11 increased the relevant responsibilities of the medical device standard management center，Clarify the draft of the standard planning of medical equipment for its organization、Organization Standard System Study; Affairs of Standard System Amendment Management in accordance with the law、The management of the bidding committee and the implementation of the organization standards。
Article 12 Clarified the legal procedure formed by the Standardization Technology Committee of the Medical Device，According to the "Provisions on the Management of the National Professional Standardization Technical Committee"，Clarifying the medical device standardization technical committee is "the needs of the State Food and Drug Administration according to the needs of the standardization of medical device，The medical device standardization technical committee approved according to law。"" At the same time, it is clear that its responsibilities should be performed。
Article 13 increased the responsibility of the medical device technology batch unit。High -tech density in the field of medical device，There are professional and technical fields that existing medical device standardization technical committees cannot cover。According to regulatory needs，According to the program, you can determine the standardized technology of medical equipment for the export unit。also stipulated that the port unit can carry out work with reference to related duties，For professional technical ability and conditions、But the standard work that has not yet established a technical committee to carry out the urgent need of supervision provides a basis。
Article 14 adds the responsibility of the local food and drug supervision and management department。Focus on the implementation of the standards for supervising medical equipment in accordance with the law，Responsibilities of collecting feedback issues。
Article 15 increased the responsibilities of the relevant unit，Clarifying the development institution of medical device、Production and operation enterprises and use units shall implement the compulsory standards of medical device。At the same time, encourage enterprises to actively develop and adopt recommendation standards，Actively participate in the revision of the standard system，Actively undertake the drafting work of recommended standards for medical devices，Give full play to the role of the enterprise。

6. Regarding standard formulation and revision

"Measures" stipulates the working procedure of the standard revision of the medical device standard。Clarifying the standards of urgent need to be revised for medical device supervision can be carried out in accordance with the rapid procedure stipulated by the State Food and Drug Administration。
Simultaneous revision of each link on the standard system，Including the establishment item、Draft、​​Soliciting Opinions、Technical review、Approval release、Review and abolition，All specified as separate terms，and put forward requirements for the key content of each link，It has stronger guidance and operability。
About Standard Teritors，"Measures" added the collection of project proposals、Application application for review、stake sports betting appStandard plan project publicity and approval and other procedures。Article 17 The provisions shall be planned in accordance with the standard，Publicly solicited the amendment to the standard system of medical device standards to publicly solicit the proposal; Article 18 clearly clearly requested that the standard plan items that have been approved should be publicized to the society，further improves social participation and transparency。
About standard drafting，Article 19 stipulates that any medical device production and operation enterprise、Use unit、Regulatory authorities、Inspection institutions and related education and research institutions、Social groups, etc.，All can apply to the medical device standardization technical committee that undertakes the medical device stake sports betting appStandard plan project.，Medical Devices Standardization Technical Committee combined with standard technical content，According to public、Justice、Principles of selecting best，Select the drafting unit。
About Standard Consultation，Article 20 Clarified the Draft for Consultation of the Medical Device Standard，It should be solicited from the society on the website of the Medical Device Standard Management Center，The deadline for soliciting opinions is generally two months。Consultation work is uniformly organized by the Medical Device Standard Management Center。
About standard public，Article 22 stipulates national standards for medical devices、Industry standards in accordance with the relevant provisions of the National Standardization Management Committee，For the public to check，Added the strength of the standard openness，Improving the standard of standard。At the same time, Article 30 has added information management requirements for medical device standards，Standard Standard Standards、Published、Implementation and other information should be made to the public，improved the transparency of standard management。
About standard review，According to the relevant provisions of the Implementation Regulations of the Standardization Law，Article 24 Clarify the medical device standardization technical committee in response to the release of medical device standards for review，According to the progress of science and technology、Industrial development and supervision need to be effective for it、Applicability and advanced, organize review。and stipulate that the review cycle does not exceed 5 years in principle。

7. Regarding standard implementation and supervision

"Measures" clarify the compulsory standard、The implementation and supervision requirements of recommendation standards and product technical requirements。
Article 25 stipulates that medical device enterprises shall be organized in strict accordance with the registered or recorded product technical requirements，Make sure that the medical equipment from the factory meets the compulsory standards and the registered or filed product technical requirements。It emphasizes the status of compulsory standards in medical device supervision。
Article 26 Emphasize Recommended Standards Once Laws and Regulations、Normal documents and registered or filed product technical requirements for technical requirements stake betting appreferenced should be enforced。Clarified the implementation requirements of the recommended standards for medical device in the corresponding situation。
Article 27 clearly stipulates that the technical requirements of medical device product products shall not be lower than the compulsory national standards and compulsory industry standards applicable to the product，Establishment of the connection between the technical requirements of the product and the mandatory standard。
Article 28 Requires the food and drug supervision and management department to respond to medical device enterprises to implement medical device compulsory standards and registered or filing product technical requirements for supervision and inspection。
At the same time，Evaluation of the implementation of strengthening medical equipment standards，Article 32 Clarify the implementation of the medical device standardization technical committee or the technical portfolio of the standard for standardization and evaluation，and stipulate that the medical device standard management center conducts statistical analysis of it，A closed -loop management of medical equipment standards，Continuous improvement of standard quality。

8. About group standards

​​"Measures" Article 34 adds the content of the group standard，Encouraging social groups established in accordance with the law can formulate and release group standards，Its management shall comply with relevant national regulations。This clause increases the effective supply of medical device standards，Promote the reform of the standard supply side of medical equipment，Connect with the overall thinking of national standardization reform，Better responded to innovation and market demand in the field of medical device。