国家食品药品监督管理局

主要职责：

    （一）制定药品、医疗器械、化妆品和消费环节食品安全监督管理的政策、规划并监督实施，参与起草相关法律法规和部门规章草案。

（二）负责消费环节食品卫生许可和食品安全监督管理。

（三）制定消费环节食品安全管理规范并监督实施，开展消费环节食品安全状况调查和监测工作，发布与消费环节食品安全监管有关的信息。

（四）负责化妆品卫生许可、卫生监督管理和有关化妆品的审批工作。

（五）负责药品、医疗器械行政监督和技术监督，负责制定药品和医疗器械研制、生产、流通、使用方面的质量管理规范并监督实施。

（六） 负责药品、医疗器械注册和监督管理，拟订国家药品、医疗器械标准并监督实施，组织开展药品不良反应和医疗器械不良事件监测，负责药品、医疗器械再评价和淘 汰，参与制定国家基本药物目录，配合有关部门实施国家基本药物制度，组织实施处方药和非处方药分类管理制度。

（七）负责制定中药、民族药监督管理规范并组织实施，拟订中药、民族药质量标准，组织制定中药材生产质量管理规范、中药饮片炮制规范并监督实施，组织实施中药品种保护制度。

（八）监督管理药品、医疗器械质量安全，监督管理放射性药品、麻醉药品、毒性药品及精神药品，发布药品、医疗器械质量安全信息。

（九）组织查处消费环节食品安全和药品、医疗器械、化妆品等的研制、生产、流通、使用方面的违法行为。

（十）指导地方食品药品有关方面的监督管理、应急、稽查和信息化建设工作。

（十一）拟订并完善执业药师资格准入制度，指导监督执业药师注册工作。

（十二）开展与食品药品监督管理有关的国际交流与合作。

（十三）承办国务院及卫生部交办的其他事项。

State Food and Drug Administration

Main Responsibilities：

1. To organize relevant authorities to draft laws and regulations on the safety management of food, health food and cosmetics; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation.

2. To exercise comprehensive supervision on the safety management of food, health food and cosmetics in accordance with laws; organize and coordinate supervision work on safety of food, health food and cosmetics carried out by relevant authorities.

3. To organize and carry out investigation and impose punishment on serious safety accidents of food, health food and cosmetics; delegated by the State Council, organize, coordinate and conduct specific law-enforcement campaigns over safety of food, health food and cosmetics nationwide; organize, coordinate and collaborate with relevant authorities in carrying out emergency rescue work on serious safety accidents of food, health food and cosmetics.

4. To comprehensively coordinate the testing and evaluation for the safety of food, health food and cosmetics; formulate provisions on releasing of supervision information for safety of food, health food and cosmetics in conjunction with relevant authorities and monitor their implementation; sum up safety information of food, health food and cosmetics from relevant authorities and release it to the public regularly.

5. To draft law and administrative regulations on drug administration and supervise their enforcement; carry out protection system for certain traditional Chinese medicinal preparations and administrative protection system for pharmaceuticals in accordance with law or regulations.

6. To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation.

7. To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up criteria for marketing authoriazation of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate national essential medicines list.

8. To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.

9. To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law.

10. To regulate radioactive pharmaceuticals, narcotics, toxics, psychotropics, and other controlled drugs and devices in accordance with law.

11. To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.

12. To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.

13. To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.

14. To undertake other work assigned by the State Council.

医疗器械监管司

主要职责是：组织拟订国家医疗器械标准并监督实施；拟订医疗器械分类管理目录；承担医疗器械的注册和监督管理工作；拟订医疗器械临床试验、生产、经营质量 管理规范并监督实施；拟订医疗器械生产、经营企业准入条件并监督实施；承担医疗器械临床试验机构资格认定工作；负责组织和管理医疗器械注册现场核查工作； 承担医疗器械检测机构资格认定和监督管理；承担医疗器械生产、经营许可的监督工作；承担有关指定医疗器械产品出口监管事项；组织开展医疗器械不良事件监 测、再评价和淘汰工作；承办局交办的其他事项。

Department of Medical Devices

To draft relevant national standards, draw up and revise professional standards, good manufacturing practices of medical devices and medical dressings and supervise their implementation; formulate the list of classified medical devices in consultation with health authority under State Council; be in charge of registration and regulation of medical devices; monitor adverse events of medical devices; certify clinical study bases, testing institutions, quality system auditing institutions of medical devices.

There are four divisions under the Department ,including:
--------Division of General Affairs
--------Division of Standards

• organizing to draft and revise the official standard for medical devices (including medical dressing, chemical and biochemical diagnostic reagents in vitro), and undertaking the work related with International Organization for Standardization.
• formulating classified management list for medical devices in consultation with health department under the State Council, and organizing the management of classification of medical devices;
• assessing the qualification of testing institutions.
• formulating the list of medical measuring products.

--------Division of Product Registration

• approval and registration of medical devices (including import medical dressings, chemical and biochemical diagnostic reagents in vitro);
• assessing the qualification of medical device clinical trial bases;
• approval of clinical trials of medical devices;
• managing the database of medical device review experts;
• issue of the medical device export certificates;
• application acceptance and certificate issue for medical devices.

--------Division of Safety Supervision

• organizing to draft and revise the provisions for implementation of medical device manufacturing certification, good manufacturing practice and supervising their implementation;
• organizing to supervise and inspect medical device manufacturers;
• assessing the qualification of institutions conducting evaluation of good manufacturing practice for medical devices;
• organizing medical device adverse event monitoring and re-evaluation;
• comprehensive coordination and superintendence within the Department.