【正文】 e serious, an order shall be given to suspendproduction or business operation for rectification, or the drug approvaldocuments shall be withdrawn and the Drug Manufacturing Certificate, theDrug Supply Certificate, or the Pharmaceutical Preparation Certificate forMedical Institution shall be revoked.(3)構(gòu)成犯罪的，依法追究刑事責(zé)任。 If a crime is constituted, criminal liabilities shall be investigated underthe law.，是指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥或者功能主治、用法和用量的物質(zhì)，包括中藥材、中藥飲片、中成藥、化學(xué)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 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。 Excipients refer to the vehicles and additives intended for manufacturingdrug dosage forms and prescription dispensing.，是指生產(chǎn)藥品的專(zhuān)營(yíng)企業(yè)或者兼營(yíng)企業(yè)。Drug manufacturers refer to enterprises exclusively or partly engaged indrug production.，是指經(jīng)營(yíng)藥品的專(zhuān)營(yíng)企業(yè)或者兼營(yíng)企業(yè)。 Drug distributors refer to enterprises exclusively or partly engaged in drugdistribution.。The drug regulatory agency of the State Council is responsible forsupervision and administration of medical devices nationwide.。The State shall carry out the policy of classification administration ofmedical devices.。The State shall implement a product registration system for manufacturingmedical devices.，由設(shè)區(qū)的市級(jí)人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。Class I medical devices shall be inspected, approved and issued aregistration certificate by the drug regulatory agency of the government ofthe 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(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。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(guó)務(wù)院藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。生產(chǎn)第二類(lèi)、第三類(lèi)醫(yī)療器械，應(yīng)當(dāng)通過(guò)臨床驗(yàn)證。Class Ⅲ medical devices shall be inspected, approved and issuedregistration certificates by the drug regulatory agency directly under theState Council.。The term of validity for the registration certificate of medical devices isfour years.，應(yīng)當(dāng)符合醫(yī)療器械國(guó)家標(biāo)準(zhǔn)；沒(méi)有國(guó)家標(biāo)準(zhǔn)的，應(yīng)當(dāng)符合醫(yī)療器械行業(yè)標(biāo)準(zhǔn)。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(guó)家有關(guān)標(biāo)準(zhǔn)或者規(guī)定。The instruction for use, label and package of medical devices shall plywith relevant standards or provisions in China.，標(biāo)明產(chǎn)品注冊(cè)證書(shū)編號(hào)。The registration number of a medical device shall be marked on the productitself and on the external package according to the provisions of the drugregulatory agency of the State Council.，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(mén)備案。For the manufacturing of class I medical devices, it requires that theenterprise file a record with the drug regulatory agency of provinces,autonomous regions or municipalities directly under the Central Government.、第三類(lèi)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(mén)審查批準(zhǔn)，并發(fā)給《醫(yī)療器械生產(chǎn)企業(yè)許可證》。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。The term of validity of the Medical Device Manufacturing Enterprise Licenseis 5 years. Upon expiration, reinspection and license renewal shall beconducted.、無(wú)合格證明、過(guò)期、失效或者淘汰的醫(yī)療器械。Medical institutions shall not use medical devices without registration, orwithout certificate for qualified products, or they shall not use medicaldevices which are beyond their expiry dates, of promised effectiveness,or obsolete.、無(wú)合格證明、過(guò)期、失效或者淘汰的醫(yī)療器械。Distribution enterprises shall not distribute medical devices withoutregistration certificates or certificates for qualified products, or medicaldevices which are beyond their expiry dates, of promised effectiveness,or obsolete.《醫(yī)療器械生產(chǎn)企業(yè)許可證》的生產(chǎn)企業(yè)或者取得《醫(yī)療器械經(jīng)營(yíng)企業(yè)許可證》的經(jīng)營(yíng)企業(yè)購(gòu)進(jìn)合格的醫(yī)療器械，并驗(yàn)明產(chǎn)品合格證明。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(guò)的，應(yīng)當(dāng)按照國(guó)家有關(guān)規(guī)定銷(xiāo)毀，并作記錄。Medical institutions shall not reuse medical devices labeled for singleuse, and shall destroy them after use with record, according to relevantprovisions of the state.。The State shall establish a reporting system for quality accident and anotifying system of medical devices.，方可對(duì)醫(yī)療器械實(shí)施檢測(cè)。Only testing institutions accredited by the drug regulatory agency inconjunction with the quality and technical supervision agency of the StateCouncil may conduct medical device test.，并不得從事或者參與同檢測(cè)有關(guān)的醫(yī)療器械的研制、生產(chǎn)、經(jīng)營(yíng)和技術(shù)咨詢等活動(dòng)。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(jí)以上地方人民政府藥品監(jiān)督管理部門(mén)可以予以查封、扣押。For products having caused or which may potentially cause quality incidents,the drug regulatory agency of the governments at county level and aboveshall have the right to check, seal up and detain them together withmaterials related.；未