【正文】 rding to relevant regulations, and no fees are permitted to be charged for sampling or testing. 、扣押的行政強制措施。The drug regulatory agency shall take administrative enforcement to seal or seize the drugs and related materials proved to be potentially harmful to human health and shall. ，依據《藥品生產質量管理規(guī)范》、《藥品經營質量管理規(guī)范》，對經其認證合格的藥品生產企業(yè)、藥品經營企業(yè)進行認證后的跟蹤檢查。 Drug regulatory agencies shall, in accordance with regulations and on the basis of the GMP and GSP, make the followup inspection on the certified drug manufacturers and distributors.、審批等手段限制或者排斥非本地區(qū)藥品生產企業(yè)依照本法規(guī)定生產的藥品進入本地區(qū)。 With regard to the drugs produced according to the provisions of this Law by drug manufacturers not located in the region, the local government and drug regulatory agency are not permitted to restrict or refuse their access to the region. The State has established and exercised the reporting system on adverse drug reaction (ADR).《藥品生產許可證》、《藥品經營許可證》或者《醫(yī)療機構制劑許可證》生產藥品、經營藥品的，依法予以取締 Without Drug Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical Preparation Certificate for Medical Institution, the manufacturer or distributor of drug or medical institution shall be banned to produce or distribute drugs.111.(1)生產、銷售假藥的，沒收違法生產、銷售的藥品和違法所得，并處違法生產、銷售藥品貨值金額二倍以上五倍以下的罰款；Where counterfeit drugs are produced or sold, the drugs illegally produced or sold and the illegal ine shall be confiscated, and a fine not less than two times but not more than five times the value of the said drugs shall be collected.(2)有藥品批準證明文件的予以撤銷，并責令停產、停業(yè)整頓；The approval documents, if any, shall be withdrawn and an order shall be given to suspend production or business operation for rectification.(3)情節(jié)嚴重的，吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫(yī)療機構制劑許可證》；構成犯罪的，依法追究刑事責任。 If the circumstances are serious, the Drug Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical Preparation Certificate for Medical Institution shall be revoked. If a crime is constituted, criminal liabilities shall be investigated under the law.112.(1)生產、銷售劣藥的，沒收違法生產、銷售的藥品和違法所得，并處違法生產、銷售藥品貨值金額一倍以上三倍以下的罰款；Where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal ine shall be confiscated, and a fine not less than but not more than three times the value of the said drugs shall also be collected.(2)情節(jié)嚴重的，責令停產、停業(yè)整頓或者撤銷藥品批準證明文件、吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫(yī)療機構制劑許可證》；If the circumstances are serious, an order shall be given to suspend production or business operation for rectification, or the drug approval documents shall be withdrawn and the Drug Manufacturing Certificate, the Drug Supply Certificate, or the Pharmaceutical Preparation Certificate for Medical Institution shall be revoked.(3)構成犯罪的，依法追究刑事責任。 If a crime is constituted, criminal liabilities shall be investigated under the law.，是指用于預防、治療、診斷人的疾病，有目的地調節(jié)人的生理機能并規(guī)定有適應癥或者功能主治、用法和用量的物質，包括中藥材、中藥飲片、中成藥、化學原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。 Drugs refer to the products that are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, with specifications of indications, usage and dosage. They include Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicines, chemical drug substances (API) and their preparations, antibiotics, biochemical drugs, radioactive pharmaceuticals, serum, vaccines, blood products, and diagnostic agents.，是指生產藥品和調配處方時所用的賦形劑和附加劑。 Excipients refer to the vehicles and additives intended for manufacturing drug dosage forms and prescription dispensing.，是指生產藥品的專營企業(yè)或者兼營企業(yè)。Drug manufacturers refer to enterprises exclusively or partly engaged in drug production.，是指經營藥品的專營企業(yè)或者兼營企業(yè)。 Drug distributors refer to enterprises exclusively or partly engaged in drug distribution.The drug regulatory agency of the State Council is responsible for supervision and administration of medical devices nationwide.The State shall carry out the policy of classification administration of medical devices.The State shall implement a product registration system for manufacturing medical devices.，由設區(qū)的市級人民政府藥品監(jiān)督管理部門審查批準，并發(fā)給產品生產注冊證書。Class I medical devices shall be inspected, approved and issued a registration certificate by the drug regulatory agency of the government of the municipalities with districts.，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門審查批準，并發(fā)給產品生產注冊證書。Class Ⅱ medical devices shall be inspected, approved and issued registration certificates by the drug regulatory agency of provinces, autonomous regions and municipalities directly of the Central Government.，由國務院藥品監(jiān)督管理部門審查批準，并發(fā)給產品生產注冊證書。生產第二類、第三類醫(yī)療器械，應當通過臨床驗證。Class Ⅲ medical devices shall be inspected, approved and issued registration certificates by the drug regulatory agency directly under the State Council.The term of validity for the registration certificate of medical devices is four years.，應當符合醫(yī)療器械國家標準；沒有國家標準的，應當符合醫(yī)療器械行業(yè)標準。Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.、標簽、包裝應當符合國家有關標準或者規(guī)定。The instruction for use, label and package of medical devices shall ply with relevant standards or provisions in China.，標明產品注冊證書編號。The registration number of a medical device shall be marked on the product itself and on the external package according to the provisions of the drug regulatory agency of the State Council.，應當向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門備案。For the manufacturing of class I medical devices, it requires that the enterprise file a record with the drug regulatory agency of provinces, autonomous regions or municipalities directly under the Central Government.、第三類醫(yī)療器械生產企業(yè)， 應當經省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門審查批準，并發(fā)給《醫(yī)療器械生產企業(yè)許可證》。For the manufacturing of class Ⅱ and/or class Ⅲ medical devices, it requires inspection and approval by the drug regulatory agency of the provinces, autonomous regions and municipalities directly under t