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Major Duties

  (I) To implement national laws, regulations, rules, guidelines, and policies governing safety of food, health products and cosmetics and regulation of drugs, pharma-packaging materials and medical devices, formulate and implement jurisdiction-specific work plans pursuant to Shanghai FDA requirements;

  (II) To conduct supervision on food, health products and cosmetics within jurisdiction, organize and coordinate investigations on and emergency relief for major safety incidents according to law;

  (III) To review and approve establishment, licensing and change of drug retailers (including retail chains) and issue drug distribution licenses;

  (IV) To review and approve establishment, licensing and change of distributors of Class II & III medical devices and issue medical device distribution licenses to these entities, document distributors of Class I and household medical devices;

  (V) To regulate psychotropic substances, narcotic and toxic drugs as well as specialty devices within jurisdiction;

  (VI) To oversee quality of drugs, pharma-packaging materials and medical devices, organize and coordinate enforcement campaigns, and investigate and punish acts of producing and/or distributing counterfeit and inferior drugs, pharma-packaging materials and medical devices as well as other acts in violation of relevant laws and regulations;

  (VII) To monitor adverse reactions to drugs and medical devices within jurisdiction;

  (VIII) And to perform other duties assigned by Shanghai FDA.

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