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Norihito medical instruments:

2017-12-25  From: Puyang Deg ren medical equipment co. ltd Browsing times:211

"Management measures" medical device standards has been passed in February 2017 21 by the State Food and drug administration executive meeting, is hereby promulgated and shall come into force as of July 1, 2017.

Director: Bi Jingquan

April 17, 2017

Standard management of medical equipment

Chapter I General rules

The first is to promote the progress of science and technology, to ensure the safety and effectiveness of medical equipment, improve health care level, strengthen the management of medical device standards, according to the "People's Republic of China People's Republic of China" standardization law "Standardization Law Implementing Regulations" and "medical equipment supervision and management regulations" and other laws and regulations, the enactment of this approach.

The second term of the medical device standards, is defined by the State Food and drug administration duties according to organization and revision, according to legal procedures, should follow the unified technology in medical equipment development, production, operation, use, supervision and management activities.

Third, the revision, implementation, supervision and management of medical device standards in People's Republic of China should comply with the provisions of laws, administrative regulations and the present measures.

The fourth medical equipment standards are divided into mandatory standards and recommended standards according to their effectiveness.

In order to ensure the technical requirements of human health and life safety, compulsory national standards and compulsory standards for medical equipment should be formulated.

The technical requirements that satisfy basic general purpose, mandatory standard and leading role in medical device industry can be formulated as recommended national standard and recommended industry standard for medical devices.

The fifth medical equipment standards are divided into basic standard, method standard, management standard and product standard according to its standard object.

The Sixth State Food and drug administration has prepared the standard plan for medical devices according to law, established the standard management system for medical devices, and improved the standard management system of medical devices.

The seventh one is to encourage enterprises, social organizations, educational research institutions and individuals to participate in the revision of medical device standards, and supervise the implementation of standards for medical devices.

The eighth article encourages participation in international standardization activities and participates in the formulation and adoption of international medical equipment standards.

Ninth, the State Food and drug administration has commended and rewarded the organizations and individuals who made notable achievements in the work of medical device standards in accordance with the relevant provisions of the state.

The second chapter standard management responsibility

The tenth State Administration of food and Drug Administration fulfills the following duties:

(1) to organize and implement relevant laws and regulations related to the standard management of medical instruments and to establish the standard management system for medical instruments;

(two) organize the standard plan of medical equipment and compile the annual work plan of standard system;

(three) to organize the revision of the standard system of medical equipment according to law, and to publish the standard of the medical equipment industry.

(four) to guide and supervise the standard management of medical instruments according to law.

The Eleventh National Food and Drug Administration medical device standard management center (hereinafter referred to as "medical device standard management center") performs the following duties.

(1) to organize the research on the standard system for medical instruments and to draw up the draft of the standard plan for medical instruments and the proposals for the revision of the annual work plan of the standard system;

(two) the management of the revision of the standard system of medical instruments in accordance with the law;

(three) to undertake the management of the Technical Committee for standardization of medical instruments in accordance with the law;

(four) organize the organization of the publicity and training of medical equipment standards;

(five) the organization of the standard implementation of the survey, to coordinate the implementation of the major technical problems in the implementation of the standard;

(six) undertake the relevant work of international standardization of medical equipment and exchange of foreign cooperation;

(seven) to undertake the informatization of medical equipment standards, and to organize the publishing of medical equipment industry standards;

(eight) to undertake other standard management work assigned by the State Administration of food and drug administration.

The twelfth state food and drug administration, according to the needs of standardization of medical devices, has been approved by law to set up a technical committee for standardization of medical devices.

The Technical Committee for standardization of medical instruments fulfills the following responsibilities:

(1) to carry out the research work on the standard of medical equipment, and put forward the views of the standard development plan and the standard system in the field of the professional field.

(two) to undertake the drafting, consultation and technical review of medical instruments in this field, and to be responsible for the technical content and quality of the standard.

(three) take the technical guidance of medical equipment standards in this field to help solve the technical problems in the implementation of the standard.

(four) to collect and organize the standard data of medical equipment in this field, and to establish technical files.

(five) the follow-up evaluation of the implementation of medical equipment standards in this field;

(six) the consultation and interpretation of the standard technical content of medical instruments in this field;

(seven) undertake the publicity, training, academic exchange and related international standardization activities of medical equipment standards in this field.

The thirteenth is in the field of professional technology that cannot be covered by the existing Standardization Committee of medical devices. The State Food and drug administration can establish the standardization unit of medical device standardization according to the regulatory requirements. Standardization Technical return units refer to the responsibilities and related aspects of the Technical Committee for standardization of medical instruments

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