【正文】 titution 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 under the 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 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(chǎn)藥品和調(diào)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(chǎn)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(jīng)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(shè)區(qū)的市級人民政府藥品監(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。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(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)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(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。生產(chǎn)第二類、第三類醫(yī)療器械，應(yīng)當(dāng)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(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)。Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.、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。The instruction for use, label and package of medical devices shall ply with relevant standards or provisions in China.，標(biāo)明產(chǎn)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(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。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(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》。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 the Central Government, who will then issue a Medical Device Manufacturing Enterprise License.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 License is 5 years. Upon expiration, reinspection and license renewal shall be conducted.、無合格證明、過期、失效或者淘汰的醫(yī)療器械。Medical institutions shall not use medical devices without registration, or without certificate for qualified products, or they shall not use medical devices which are beyond their expiry dates, of promised effectiveness, or obsolete.、無合格證明、過期、失效或者淘汰的醫(yī)療器械。Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices 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)營企業(yè)許可證》的經(jīng)營企業(yè)購進合格的醫(yī)療器械，并驗明產(chǎn)品合格證明。Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License. Their certificate 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。Medical institutions shall not reuse medical devices labeled for single use, and shall destroy them after use with record, according to relevant provisions of the state.The State shall establish a reporting system for quality accident and a notifying system of medical devices.，方可對醫(yī)療器械實施檢測。Only testing institutions accredited by the drug regulatory agency in conjunction with the quality and technical supervision agency of the State Council may conduct medical device test.，并不得從事或者參與同檢測有關(guān)的醫(yī)療器械的研制、生產(chǎn)、經(jīng)營和技術(shù)咨詢等活動。Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacturing, distribution, and technical consultation 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。For products having caused or which may potentially cause quality incidents, the drug regulatory agency of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.；未經(jīng)批準(zhǔn)的，不得刊登、播放、散發(fā)和張貼。Advertisements of medical devices shall be reviewed and approved by the drug regulatory agency of governments at provincial level and above, and shall not be published, broadcast, circulated or posted before the approval.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)的使用說明書為準(zhǔn)。The contents of the advertisements shall be based on the instruction for u