【正文】 it requires inspection and approval by the drug regulatory agency of the provinces, autonomous regions and municipalities directly under the。、第三類醫(yī)療器械生產(chǎn)企業(yè)， 應(yīng)當(dāng)經(jīng)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(zhǔn)，并發(fā)給《醫(yī)療器械生產(chǎn)企業(yè)許可證》。，應(yīng)當(dāng)向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門備案。，標(biāo)明產(chǎn)品注冊(cè)證書編號(hào)。、標(biāo)簽、包裝應(yīng)當(dāng)符合國家有關(guān)標(biāo)準(zhǔn)或者規(guī)定。，應(yīng)當(dāng)符合醫(yī)療器械國家標(biāo)準(zhǔn)；沒有國家標(biāo)準(zhǔn)的，應(yīng)當(dāng)符合醫(yī)療器械行業(yè)標(biāo)準(zhǔn)。生產(chǎn)第二類、第三類醫(yī)療器械，應(yīng)當(dāng)通過臨床驗(yàn)證。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.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.The State shall implement a product registration system for manufacturing medical devices.The State shall carry out the policy of classification administration of medical devices.The drug regulatory agency of the State Council is responsible for supervision and administration of medical devices nationwide. Drug distributors refer to enterprises exclusively or partly engaged in drug distribution.Drug manufacturers refer to enterprises exclusively or partly engaged in drug production. Excipients refer to the vehicles and additives intended for manufacturing drug dosage forms and prescription dispensing. 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. If a crime is constituted, criminal liabilities shall be investigated under the law. 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.(2)有藥品批準(zhǔn)證明文件的予以撤銷，并責(zé)令停產(chǎn)、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.《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)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.。、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進(jìn)入本地區(qū)。，依據(jù)《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營質(zhì)量管理規(guī)范》，對(duì)經(jīng)其認(rèn)證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)進(jìn)行認(rèn)證后的跟蹤檢查。、扣押的行政強(qiáng)制措施。，并不得收取任何費(fèi)用。，可以對(duì)藥品質(zhì)量進(jìn)行抽查檢驗(yàn)。，必須出示證明文件，對(duì)監(jiān)督檢查中知悉的被檢查人的技術(shù)秘密和業(yè)務(wù)秘密應(yīng)當(dāng)保密。 No unscientific conclusion or guarantee on drug efficacy is permitted to be included in drug advertisement。 The content of drug advertisement shall be truthful and lawful, and shall be based on the insert sheet approved by the drug regulatory agency of the State Council. The false content shall not be contained in advertisement. but their advertisements are not permitted to be released by mass media or disseminated to the general public by other means.、藥學(xué)專業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進(jìn)行以公眾為對(duì)象的廣告宣傳。、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品廣告批準(zhǔn)文號(hào)；未取得藥品廣告批準(zhǔn)文號(hào)的，不得發(fā)布。、經(jīng)營企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員以財(cái)物或者其他利益。 Drug manufacturers, drug distributors and medical institutions are prohibited from secret Drug manufacturers, drug distributors and medical institutions shall ply with the prices fixed or guided by the government. No one is permitted to raise prices in any manner without authorization. Specified marks shall be printed in the label of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, drugs for topical use, and nonprescription drugs. In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions. A label shall be printed or stuck on the drug package with an insert sheet attached as required by regulations. Immediate packaging materials and containers shall meet the requirements for medicinal use and ply with the standards for ensuring human health and safety. They along with the drugs shall be subject to reviewing and approval by the drug regulatory agency. Those who suffer from infectious diseases or any other diseases that may cause drug contamination are not permitted to undertake any job in direct contact with drugs.Staff members of drug manufacturers, drug distributors and medical institutions who make a direct contact with drugs shall receive physical examination annually. A drug name listed in the National Drug Standards is an adopted name in China. Such an adopted name is not permitted to be used as a trademark.。 or（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的； No approval certificate is obtained for the immediate packaging material or container。（二）不注明或者更改生產(chǎn)批號(hào)的； The batch number is not indicated or is altered。 A drug with content not up to the National Drug Standards is a drug of inferior quality. Production and distribution of drugs of inferior quality are prohibited. The indications or functions indicated are beyond the specified scope. （五）使用依照本法必須取得批準(zhǔn)文號(hào)而未取得批準(zhǔn)文號(hào)的原料藥生產(chǎn)的； It is produced by using active pharmaceutical ingredients without approval number as required by this Law。（四）被污染的； It is contaminated。（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。 It is not