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Osmunda Medical Device Consulting Organization1、Brief IntroductionOsmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in the field of medical device in China. All Osmunda Consultant team members are from sizeable medical devices enterprises, well-known notified bodies and testing organizations. We are well versed in global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification etc. Our service includes clean room design, clinical trail, third party audit, training of regulations and standards, etc.Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, and Jinan) which could provide high-speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.2、SFDA RegistrationBased on the potential risks and intended use, medical devices are divided into three management categories by SFDA of China (State Food and Drug Administration). All medical devices need to be registered according to Medical Device Registration Administration in order to be sold and used in China.Different countries have different regulations about medical devices, relying on the deep understanding of various regulations and abundant practical experience, Osmunda could help your products be easily approved by SFDA and be widely applied into the Chinese market.3、SFDA IVDD RegistrationCurrently in China, except the in vitro diagnostic reagents (IVDD) used for blood screening and radioisotope labeling, other IVDD may be managed as medical device (MD). IVDD is divided into three management categories according to its risk level. There are some special requirements during the IVDD registration in addition to the general regulations of medical device.During the SFDA registration, the class 2 and class 3 of IVDD are required to conduct clinical trial in China. Osmunda has rich clinical resource and experience and would provide you with best comprehensive services.4. Clinical Trial Service in ChinaAs for the imported medical devices needed clinical trial in China, Osmunda could assist enterprises in medical institute choosing, clinical program preparing, clinical trial following-up, statistic analysis conducting and final clinical trial report obtaining. According to relevant requirements, at least two hospitals should be chosen for theclinical trial. Osmunda has helped enterprises to conduct the clinical trial in several dozens of clinical trial institutions (hospitals) in several cities.5.Factory Inspection Service in ChinaOsmunda could provide second/third party audit and exported inspection to medical device suppliers in China for foreign clients or buyers, to ensure the supplied products meet the contract requirements and other special requirements of buyers, and the certified products meet national certification standard and be consistent with prototype sample in stipulated extend.6. Medical Device Professional Translation ServiceProfessional translation of medical device, compared with general translation, needs higher requirements for translators. Osmunda has an excellent translation team with professional knowledge of medical device, rich industry experience and excellent bilingual translation to help you clear the language barriers when your products are introduced into Chinese market.7. Quality System Inspection Service in ChinaWe help the suppliers and Original Equipment Manufactures (OEM) of foreign medical device enterprises in China to establish the Quality Management System meeting different national requirements, such as: FDA 21 CFR 820, ISO 13485,B-GMP, etc., and to continuously standardize and improve the operation and successfully pass the inspection of foreign clients or authorities.8. Chinese Agent ServiceAccording to the SFDA registration of imported medical device, if not owning any branches in China, the foreign enterprises are required to designate an independent legal entity in China as their agent and after-sale service agency. Osmunda (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, and Jinan) is designated as an agent and after-sale agency, who would directly and effectively communicate with the SFDA, deliver regulatory information to foreign enterprises, resolve relevant problems and provide regulatory supports for their Chinese market development.9. Medical Device Investment Service in ChinaAs the leading information supplier of medical device industry in China, we have an insight into industry development, deeply understanding of client’s challenges and needs. Chinese market is full of unlimited opportunities for global medical device enterprises. Osmunda would help you develop a complete market analysis and investment strategy of Chinese medical device, including the analysis of product, price, market opportunity, sales channel, industry competition, product inventory, trade data, personnel supply, etc., to master the latest investment hot spot and opportunity in Chinese medical device industry.。

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医院常用双语标识------卫生部版之欧阳语创编

医院常用双语标识------卫生部版之欧阳语创编


中文名称 停车场 问讯处 盖章处 饮水处 服务台 卫生间 男厕所 女厕所 吸烟室 残疾人专用 小卖部 咖啡厅 公用电话（IC 卡电话） 报刊亭 安全出口 消防器材 禁止吸烟、饮食、逗留 小心玻璃 小心地滑 请勿触摸 暂停服务 老年人、残疾人、军人优先 严禁明火/防止火灾 非公莫入 请关闭通讯工具 闭路电视监视区域 患者止步 自动取款机 灭火器 壁式消防栓 室外消防栓 消防应急面罩
建筑标识
英文名称 Outpatient Area Inpatient Area Experimental Area Administrative Area Staff Dormitories Clean Zone Semi-Contaminated Zone Contaminated Zone Waiting Area Visitor Waiting Area Patient Entrance Visitor Entrance
英文名称 Outpatient Dept. Registration Laboratory/Lab Cashier Outpatient Operating Room Injection & Transfusion Room Outpatient Pharmacy/Outpatient Dispensary Reception Outpatient Treatment Room Ordinary Blood Drawing Room Hepatitis A Clinic Hepatitis B Clinic Enteric Diseases Clinic Measles Clinic Chicken Pox Clinic Scarlet Fever Clinic mumps Clinic Enteric Infusion Room Isolated Blood Drawing Room Specialist Clinic ConsultationCenter RegularPhysicalExaminationCenter
医药研发RO行业报告

医药研发RO行业报告

医药研发外包合同–C R O行业报告1.1 CRO介绍CRO（Contract Research Organization）即合同研究组织，在最广泛的意义上，可以将其定义为一种商业化组织，负责实施药物开发过程所涉及的全部或部分活动。

CRO 是一种商业化或学术实体（或二者兼而有之），基本目的在于代表客户进行全部或部分的科学或医学试验，以获取商业性的或基于委托者与受委托者关系的报酬。

的专家一起加入到新药的研发中，缩短新药的研发周期。

近两三年来，新药开发的时间首度开始缩短，合同研发外包(CRO)的专业化高效率服务在其中起了一定的作用。

由CRO 承担的项目与企业自身承担的项目所需时间相比，大约可以节省1/3-1/4 的时间。

国际行业发展概况从上世纪90年代开始，一些跨国医药公司推行全球化战略，纷纷设立本土以外的研发项目，海外研发机构数量不断增加，对外海公司研发的金钱投入也大幅度增加。

20世纪90年代后期，在美国FDA的帮助下，陆续有14家CRO公司上市.目前全球CRO企业已经发展到近千家，已经成为一个独立的产业。

目前美国的CRO公司已经达到300多加，前5家美国CRO服务供应商占据了全球30%的市场份额，它们分别是：昆泰(Quintiles)、科文斯(Covance)、PPD、ICON 和 PharmaKinetes。

60CRO 市场概况3.1 CRO市场规模近20 年来，开发新药的支出节节升高。

以美国为例，1996 年卫生保健部门在药物研发上的投资约为400亿美元，到2009年该数字达到1200亿美元。

世界研发投资排名前20的公司中，有7家来自卫生保健部门，该部门研发强度最高，达到销售收入的12%。

虽然各大医药公司在研发上的投入不断攀升，新药的批准上市数量却呈现下行趋势，新药研发风险越来越大。

有关资料表明：整体上完成Ⅲ期临床试验的NCE 有1／3 不能获准上市；药品从早期开发到上市销售的成功率，欧洲为1／4317，美国仅为1／6155；一个大型制药公司每年可能会合in2007-2010 年全球CRO 市场规模变化趋势图数据来源：国创天成投资顾问整理分析根据Frost & Sullivan 2006年的报告，在全球生物医药产业中，CRO 承担了将近1/3 的新药开发的组织工作，在所有的Ⅱ期和Ⅲ期临床试验中，有CRO 参与的占2/3。

注射剂仿制药一致性评价法规及关键技术要求

注射剂仿制药一致性评价法规及关键技术要求

工艺组件的相容性研究思路和策略恩福（上海）检测技术有限公司林春鑫Preface《已上市化学仿制药（注射剂）一致性评价技术要求（征求意见稿）》•工艺环节。

征求意见稿中提出：“根据生产工艺进行过滤器析出物研究、相容性研究、吸附研究。

根据溶液的特点进行硅胶管等直接接触药液容器的相容性研究。

”•上市包装体系。

征求意见稿中提出：“根据产品特点选择合适的包装材料，并根据影响因素试验、加速试验和长期试验研究结果确定所采用的包装材料和容器的合理性。

建议在稳定性考察过程中增加样品倒置考察，以全面研究内容物与胶塞等密封组件的相容性。

”•一些输液品种，例如氯化钠注射液、葡萄糖注射液、葡萄糖氯化钠注射液、注射用水等，相容性研究不可豁免。

Introduction 如何解读一份包材相容性研究报告生产工艺过程耗材组件的相容性研究NSF上海实验室介绍第一部分如何解读一份包材相容性研究报告一份合格的相容性研究报告需要包括4个部分合理的阈值设定准确的提取条件广谱的待检物质专业的毒理评估1 阈值设定•SCT安全关注阈值–口鼻吸入给药制剂< 0.15 µg / 天（国际药用气雾剂联盟推荐阈值）–肠胃途径给药及其他剂型< 1.5 µg / 天在日摄入量小于SCT时，可不用考虑浸出物的潜在致癌毒性与非致癌毒性。

•TTC毒理学关注阈值•QT界定阈值–在无SAR结构时可以使用，总量<5ug/天•AET(分析评价阈值)–基于药品规格、日摄入量及SCT值推算而得高于分析评价阈值AET时应对提取物进行定性和定量•假设一个药品是：–注射剂，SCT=1.5ug/day–规格：10mg:2mL/支–用法用量：日摄入量为20mg，即2支/天•AET=SCT药品用法用量=1.5ug/天2支/天=0.75ug/支（或=0.38ug/ml）•仪器LOQ≤AET不同剂型药品的安全限药品经口鼻吸入剂(OINDP) 注射剂眼用剂代表剂型定量雾化吸入器(MDI)预灌封注射器(PFS)小体积和大体积肠外使用 (瓶, 静脉输液袋)局部给药和悬浮剂 (眼药水)典型的给药途径经肺的血液和组织外用，眼用SCT 0.15 µg/天 1.5 µg/天未定可按照1 ppm或者更低的限值报告备注风险最高，使用最保守的SCT PQRI-PODP指导原则在草拟中FDA倾向于具体分析参考•PQRI-OINDP指导原则2006•E&L 手册2012•USP <1664.1>•PQRI-PODP WG•Paskiet et al., PDA J.Pharm. Sci Technol.,2013, 67 (5) 430-447•无官方发布•PQRI Workshop2 准确的提取条件•提取溶剂水性的–生理盐水水性的- pH 7.0混合的–异丙醇/水有机的–甲醇有机的–正己烷有机的- 二氯甲烷•提取方法在密闭容器中超声提取高温和高压提取索式提取和回流提取中性溶剂考虑极性较强的从实际出发，提取条件应该较强，但不应太过激烈以至于改变包装材料的质或量的剧烈变化*实际条件1 条件2冷藏存放 60℃烘箱加热 200℃酸消解室温存放索氏提取有机试剂溶解长期放置加速实验微波消解*摘自PDA J Pharm Sci Technology 的Jenke博士于2003年的发言3 广谱的待检物质•溶剂残留（例如聚合过程中使用的溶剂） •多聚物（单体、寡聚物） •加速剂 •聚合物或橡胶添加剂 –抗氧剂 –光稳定剂 –塑化剂 –润滑剂 –除酸剂 –色母粒 –澄清剂 –交联剂（橡胶中） –加速剂（橡胶中） •聚合物添加剂降解产物 •聚合物降解产物 •粘合剂4 专业的毒理学评估过程•人体研究•实验室动物研究•体外试验•计算机软件分析（例如QSAR分析）•综合评估（Cross Read）相容性研究的整体过程四、毒理学评估：对获得的定量和定性结果进行专业分析给出结论。

医疗器械监督管理条例英文版

医疗器械监督管理条例英文版

Regulations for the Supervision and Administration of Medical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the People's Republic of China shall comply with the Regulation.Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide. The drug administration of the local government at county level and above is responsible for supervision and administration of medical devices in each administrative region. The drug regulatory authority under the State Council shall coordinate with other departments under the State Council, responsible for comprehensive economic administration, in the implementation of policies for the medical device industry.Article 5 The State shall classify medical devices and administer them based on this classificationClass I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.Article 6 Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority.Chapter II The Administration of Medical DevicesArticle 7 The State encourages the research and development of new medical devices. "New medical devices" refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council.New medical devices that have completed clinical trials and passed experts' evaluation and review organized by the drug regulatory authority under State Council, shall receive a new product certificate after being approved by the same organization.Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production.Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions. The drug regulatory authority under the State Council is responsible for the inspection and approval of clinical trial or verification of class III medical devices.Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial or verification, in accordance with the related provisions of the drug regulatory authority under the StateCouncil.The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the State Council.Article 10 Medical institutions may develop medical devices to serve their own clinical needs, and use them within their own institution under the guidance of licensed medical practitioners.Class II medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority of the government at provincial level and above. Class III medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority under the State Council.Article 11 When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issued by the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.Article 12 When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions of the drug regulatory authority under the State Council.The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.Article 13 In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change.Article 14 The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires.When the manufacturing of a medical device is stopped continuously for more than 2 years, its registrationcertificate is automatically invalidated.Article 15 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.National standards of medical devices shall be formulated jointly by the standardization authority and the drug regulatory authority under the State Council. Professional standards of medical devices shall be formulated by the drug regulatory authority under the State Council.Article 16 The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.Article 17 The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.Article 18 The State implements a system of re-evaluation and obsolescence for medical devices, the details of which shall be formulated by drug regulatory authority under the State Council after consulting with other related authorities under the State Council.Chapter III Administration of Production, Distribution and Useof Medical DevicesArticle 19 Enterprises manufacturing medical devices shall meet the following conditions:1. Possess professional technical personnel required for the manufacture of its medical devices;2. Possess facility and environment required for the manufacture of its medical devices;3. Possess equipment required for the manufacture of its medical devices;4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.Article 20 Establishment of manufacturing of class I medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing manufacturing of class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License.The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtainingthe manufacturing enterprise license.Article 22 The State implements a mandatory safety certification system for certain class III medical devices.A specific product list shall be established by the drug regulatory authority under the State Council, jointly with the quality and technology supervision authority.Article 23 Enterprises distributing medical devices shall meet the following conditions:1. Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;2. Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;3. Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;Article 24 Establishing of distribution of class II and/or class III medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing an enterprise distributing class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 25 The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 30 working days whether the licenses for manufacturing or distributing enterprises of medical devices can be issued, counting from the date of acceptance of the application. When a license is not issued, a written explanation shall be given to the applicant.Article 26 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, and shall verify the certificates of qualified products.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 compromised effectiveness, or obsolete.Medical institutions shall not use medical devices without registration, or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Article 27 Medical institutions shall not re-use medical devices labeled for single use, shall destroy them after use and establish a record, according to relevant provisions of the country.Article 28 The State shall establish a quality incident reporting system and a warning system of medical devices. Implementation details shall be stipulated by the drug regulatory authority under the State Council, in conjunction with the health authority and family planning authority under the State Council.Chapter IV Supervision of Medical DevicesArticle 29 The drug regulatory authorities of governments at county level and above shall appoint medical device monitors within their organization, who are responsible for the supervision and inspection of medical device manufacturing enterprises, distribution enterprises and medical institutions within their own administrative regions. When necessary, monitors may take product samples and ask for relevant materials according to the provisions promulgated by the drug regulatory authority under the State Council. Institutions and individuals concerned shall not decline cooperation or be deceitful in the monitoring process. The monitors shall be responsible to keep collected samples and materials confidential.Article 30 The State implements an accreditation system for the qualification of the testing institutions of medical devices. Only testing institutions accredited by the drug regulatory authority in conjunction with the quality and technical supervision authority under the State Council may conduct medical device test.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, manufacture, distribution and technical consultation related to the devices tested.Article 31 For products having caused or which may potentially cause quality incidents, the drug regulatory authority of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.Article 32 The drug regulatory authority of the governments at provincial level and above shall revoke the registration certificates of medical devices of which safety and effectiveness can not be ensured. Medical devices whose registration certificates have been revoked shall not be manufactured, distributed and used. Those already produced or imported shall be dealt with by the drug regulatory authority of government at county level and above.Article 33 The drug regulatory authorities of the government of the municipality consisting of districts and above, which perform product registrations in violation of these regulations, shall be ordered by the drug regulatory authority under the state council to correct the violations within a defined period. For those not corrected within the period, the product registration certificates may be revoked and the events may be made public.Article 34 Advertisements of medical devices shall be reviewed and approved by the drug regulatory authority of governments at provincial level and above, and shall not be published, broadcasted, circulated or posted before the approval.The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory authority under the State Council or the drug regulatory authority of the governments of provinces, autonomous regions and municipalities directly under the Central Government.Chapter V PenaltiesArticle 35 In cases of manufacturing medical devices without product registration certificates, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and related illegal income. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times the total sum of the illegal income shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in serious cases, the drug regulatory authorities of the governments at the provinces, autonomous regions and municipalities directly under the Central Government shall revoke the Medical Device Manufacturing Enterprise License; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 36 In cases of manufacturing class II and class III medical devices without a Medical Device Manufacturing Enterprise License, in violation of these regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 37 In cases of manufacturing medical devices not in conformity with national standards or professional standards for medical devices, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an warning, followed with an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the product registration certificates shall be revoked by the authorities originally issued the certificates; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 38 In cases of Distribution of class II and class III medical devices without a Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 39 In cases of distributing medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drugregulatory authority of governments at county level and above shall issue an order to stop the distribution, confiscate all of the illegally distributed products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the Medical Device Distributing Enterprise License shall be revoked by the authorities which originally issued the license; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 40 In cases where false certificates, documents, materials, or product samples are submitted in registration applications, or obtaining medical device registration certificates are obtained using other deceitful means, which violate provisions of these Regulations, the product registration certificates shall be revoked by the authorities which originally issued the certificates, and within a period of two years, other product registration applications of the violating enterprise shall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; for enterprises already started manufacturing, all of the illegally manufactured products and their illegal incomes shall be confiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 41 Violation of Article 34 of these Regulations concerning provisions for advertisement of medical devices shall be dealt with by the industrial and commercial authority according to relevant laws and regulations of the country.Article 42 In cases of Medical institutions using medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violate provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction, launch a warning, and confiscate all of the illegally used products and illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 43 In cases of medical institutions re-using devices for single use, or not destroying devices which should be destroyed, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 5 thousand to 30 thousand yuan; in serious cases, the medical institutions may be applied with a fine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and other directly responsible personnel be applied with disciplinary punishment; and in case crimes are committed, criminal liabilities shall be investigated and handled according to the law.Article 44 In cases in which medical institutions undertake clinical trials or clinical verifications of medicaldevices and provide false reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RM B 10 thousand to 30 thousand yuan；in serious cases, the qualification for clinical trial or clinical verification of medical devices shall be terminated, person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; an d in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 45 For cases in which testing institutions and their personnel are found to be conducting or involved in research and development, manufacturing, distribution and technical consultation of medical devices which are related to the testing, or establishing false testing reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 10 thousand to 30 thousand yuan; in serious cases, the qualification for testing shall be terminated by the drug regulatory authority under the State Council, person(s) in charge and other directly responsible personnel shall be receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to law.Article 46 In cases where personnel engaged in supervision and administration of medical devices abuse their power, pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of these Regulations, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled according to the law. For those not committing crimes, disciplinary punishment shall be applied according to the relevant regulations.Chapter VI Supplementary ProvisionsArticle 47 Provisions governing non-profitable contraceptive devices shall be formulated separately by the drug regulatory authority in conjunction with other relevant authorities under the State Council.Article 48 These Regulations shall come into force from April 1, 2000.。