State Administration of Medicine Medicine Standardization Management Measures

Chapter I General Provisions Article 1 In order to strengthen the standardization of the pharmaceutical industry, promote technological progress in the pharmaceutical industry, to ensure the quality of medical devices, pharmaceutical machinery, pharmaceutical intermediates and other pharmaceutical product quality, and to improve economic efficiency, according to the "Chinese People's Republic of China *** and State Standardization Law", "the Chinese People's Republic of China *** and State Standardization Law Implementation Regulations" and the State Bureau of Technical Supervision issued "National Standards Management Measures," "Industry Standards Management Measures," "Enterprise Standardization Management Measures" to formulate these measures. Measures for the Administration of Industry Standards" and "Measures for the Administration of Enterprise Standardization" issued by the State Bureau of Technical Supervision, and formulate these measures. Article 2 The State Administration of Pharmaceutical Affairs is in charge of the management of standardization in the pharmaceutical industry, is responsible for the development of standards in the industry-wide organization, the implementation of standards, supervision of the implementation of standards, guidance and promotion of enterprises to carry out standardization work. (E) medical optical instruments and equipment and endoscopes;

(F) medical ultrasound, laser, high-frequency instruments and equipment;

(G) physical therapy and traditional Chinese medicine instruments and equipment;

(H) medical radiation, high-energy and nuclear equipment;

(IX) medical biochemical instruments and laboratory equipment;

(J) the extracorporeal circulation equipment, artificial organs and their functional Auxiliary devices;

(xi) medical hygiene materials and supplies;

(xii) medical polymer products (such as: blood transfusion infusion sets, disposable syringes and other medical polymer apparatus);

(xiii) operating room equipment;

(xiv) public **** medical equipment.

Pharmaceutical Machinery

(a) pharmaceutical machinery and equipment;

(b) pharmaceutical packaging machinery;

(c) pharmaceutical monitoring and drug testing instruments;

Pharmaceutical Packaging

(a) pharmaceutical packaging materials, containers and related production equipment (including glass, plastic, rubber, metal, capsules, etc.) and pharmaceutical packaging test equipment (a) materials and containers for pharmaceutical packaging and related production equipment (including glass, plastic, rubber, metal, capsules and other products production equipment) and pharmaceutical packaging testing, testing equipment;

(b) pharmaceutical packaging standards;

Pharmaceutical raw materials, excipients category

(a) pharmaceutical raw materials (intermediates);

(b) pharmaceutical excipients;

(c) food additives;

(d) feed additives;

Pharmaceutical industry environmental protection category

(a) product production process waste pollutant limit standards;

(b) pollutant emission standards;

(c) new process technology pollutant control and management standards;

Pharmaceutical energy management category

(a) pharmaceutical industry energy management standards;

(b) product energy use Standards;

(C) energy-saving technology standards;

Pharmaceutical industry, commercial quality management standards category. Article IV of the pharmaceutical industry to develop the main content of the standard

(a) quality and technical indicators:

(b) product specifications, production processes, inspection rules, warehousing and storage, product care;

(c) safety requirements, general test methods, production, sales, use of norms;

(d) terminology, symbols, code names, general technical language requirements. Article V of the pharmaceutical technical standards are engaged in the production and distribution of goods *** with the technical basis, where the sale of pharmaceutical products as commodities, their safety requirements, the production should be unified technical indicators, methods must be formulated standards. Article VI of the pharmaceutical standardization of planning, planning, scientific research, institution-building, staffing should be included in the pharmaceutical sector at all levels of economic and social development plans. Article VII development of medical devices, pharmaceutical machinery, pharmaceutical packaging materials and containers, pharmaceutical raw materials (intermediates), excipients and other pharmaceutical standards to be adopted by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) international standards, as well as advanced standards or advanced prototypes of industrially developed countries. Chapter II Classification of standards Article VIII pharmaceutical national and industry standards are divided into mandatory standards and recommended standards. Mandatory standards mainly refers to the technical performance, manufacturing quality reasons will directly or indirectly jeopardize personal safety product standards and guide the correct production, use to protect life safety general requirements, important technical management specifications. Other standards are recommended standards.

The following products or standards should be developed mandatory standards:

(a) instead of and repair of human organs, limbs of the product; directly involved in the physiological function of the human body's artificial organs; first-aid equipment; for the treatment, diagnosis of medical equipment and appliances; directly used in the operation of the equipment and instruments; family planning devices; directly on the human body's medical appliances and materials; important medical examination and auxiliary equipment;

(2) packaging materials and containers in direct contact with drugs;

(3) mechanical equipment in direct contact with drugs, drug testing instruments, pressure vessels for medicine;

(4) pharmaceutical industry environmental protection standards;

(5) energy conservation, resource standards;

(6) the state needs to control the product General technical requirements;

(VII) laws and administrative regulations must be implemented standards.

The following standards are recommended standards:

(I) product standards with technical indicators higher than the national and industry mandatory standards;

(II) product quality grading rules;

(III) general technical management specifications;