【正文】 Medical device testing institutions and their staff members shall keepstrictly confidential all technical information provided by enterpriseswhose products are being tested, and shall not conduct or be involved inresearch and development, manufacturing, distribution, and technicalconsultation related to the devices tested.，縣級以上地方人民政府藥品監(jiān)督管理部門可以予以查封、扣押。Distribution enterprises and medical institutions shall purchase qualifiedmedical devices from enterprises having a Medical Device ManufacturingEnterprise License or Medical Device Distribution Enterprise License. Theircertificate of qualified products shall be verified.；使用過的，應(yīng)當(dāng)按照國家有關(guān)規(guī)定銷毀，并作記錄。For the manufacturing of class Ⅱ and/or class Ⅲ medical devices, itrequires inspection and approval by the drug regulatory agency of theprovinces, autonomous regions and municipalities directly under the CentralGovernment, who will then issue a Medical Device Manufacturing EnterpriseLicense.129.《醫(yī)療器械生產(chǎn)企業(yè)許可證》有效期5年，有效期屆滿應(yīng)當(dāng)重新審查發(fā)證。Medical devices manufactured shall meet the national standard, orprofessional standards when there are no relevant national standardsavailable.、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。Class Ⅱ medical devices shall be inspected, approved and issuedregistration certificates by the drug regulatory agency of provinces,autonomous regions and municipalities directly of the Central Government.，由國務(wù)院藥品監(jiān)督管理部門審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊證書。The drug regulatory agency of the State Council is responsible forsupervision and administration of medical devices nationwide.。Drugs refer to the products that are used in the prevention, treatment anddiagnosis of human diseases and intended for the regulation of thephysiological functions of human beings, with specifications of indications,usage and dosage. They include Chinese crude drugs, prepared slices ofChinese crude drugs, traditional Chinese medicines, chemical drug substances(API) and their preparations, antibiotics, biochemical drugs, radioactivepharmaceuticals, serum, vaccines, blood products, and diagnostic agents.，是指生產(chǎn)藥品和調(diào)配處方時(shí)所用的賦形劑和附加劑。 With regard to the drugs produced according to the provisions of this Law bydrug manufacturers not located in the region, the local government and drugregulatory agency are not permitted to restrict or refuse their access tothe region. 。Drug regulatory agencies may conduct selective testing of drug quality inlight of the need of supervision and inspection.，并不得收取任何費(fèi)用。 No unscientific conclusion or guarantee on drug efficacy is permitted to beincluded in drug advertisement。Drug manufacturers, drug distributors or their agents are prohibited fromoffering, under any pretence, money or goods of value or other benefits toleading people, drug purchasers, physicians, or other related persons of themedical institutions where their drugs are purchased. 、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；未取得藥品廣告批準(zhǔn)文號的，不得發(fā)布。 In the label or insert sheet shall be indicated the adopted name of thedrug, its ingredients, strength, manufacturer, approval number, productbatch number, production date, date of expiry, indications or functions,usage, dosage, contraindications, drug adverse reactions, and precautions.、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)志。Staff members of drug manufacturers, drug distributors and medicalinstitutions who make a direct contact with drugs shall receive physicalexamination annually.，不得從事直接接觸藥品的工作。 or（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。（二）不注明或者更改生產(chǎn)批號的； The batch number is not indicated or is altered。 （六）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。（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 beingtested, as required by the Law。 When major disasters, epidemic situations or other emergencies occur in thecountry, the department designated by the State Council may allocate drugsfrom the enterprises to meet the urgent need.82. 禁止生產(chǎn)（包括配制）、銷售假藥。The State adopts a protection system for certain traditional Chinesemedicines.。 The drug regulatory agency of the State Council shall organize apharmacopoeia mission, which shall be responsible for formulating andrevising the National Drug Standards.、對照品。 A drug manufacturer is permitted to produce the drug only after an approvalnumber has been granted to it.71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。 When a new drug has gone through clinical trials and passed the reviewing, aNew Drug Certificate shall be issued upon approval by the drug regulatoryagency of the State Council.量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。 The term of validation shall be noted in the Pharmaceutical PreparationCertificate for Medical Institution. For renewal of the certificate uponexpiration, reviewing and approval again is required.，應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)后方可配制。 Chinese crude drugs may be sold at fairs in urban and rural areas, exceptthose otherwise specified by the State Council.，但持有《藥品經(jīng)營許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設(shè)點(diǎn)出售中藥材以外的藥品。 In the record shall be indicated the adopted name of drugs, dosage form,strength or size, batch number, date of expiry, manufacturer, purchaser (orseller), amount of the drug purchased (or sold), purchase or selling price,date of purchase (or sale) , and other items specified by the drugregulatory agency of the State Council.，必須標(biāo)明產(chǎn)地。 The drug regulatory agency inspect a drug distributor as to its pliancewith the GSP requirements, and issue a certificate to the distributorpassing the inspection.，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購進(jìn)。(2) provided with the business operation premises, equipment,warehouses, and clear environment required for drug distribution。With the Drug Supply Certificate , the wholesaler and the retailer shall beregistered with the administrative agency for industry and merce.《藥品經(jīng)營許可證》的，不得經(jīng)營藥品。Drug manufacturers shall perform quality test of their products.、自治區(qū)、