解读医疗器械注册证号

解读医疗器械注册证号 医疗器械注册证号是医疗器械注册证的组成部分,是批准医疗器械进入市场销售、使用的法定证明文件,相当于身份证号码。熟悉医疗器械注册证号的有关知识,对识别医疗器械具有重要的意义。但是医疗器械注册号编排方式比较复杂,特别是医疗器械注册的规章和规范性文件几度改变,对识别医疗器械注册证号增加了难度。笔者通过查阅有关医疗器械注册的资料,粗读医疗器械注册证号,和同仁切磋。 一,《医疗器械监督管理条例》颁布。2000年4月1日《医疗器械监督管理条例》颁布,开始以法定的形式对医疗器械实行注册管理。同年4月10日原国家药品监督管理局以16号局令颁布了《医疗器械注册》,其注册号编排方式为:X1药管械，X2，字XXXX3第X4XX5XXXX6号。其中: X1为注册机构所在地简称，国家或省、自治区、直辖市,或省、自治区，设区市，; X2为注册形式，试、准、进，。第一类医疗器械实行直接准产注册。第二类、第三类医疗器械先办理试产注册。试产注册后的第七个月起,即可申请准产注册,进为境外企业注册形式; XXXX3为注册年份; X4为产品管理类别X; XX5为产品试产期终止年份，试产注册，或者产品品种编码，准产注册，;XXXX6为注册流水号。 layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of 如国内2001年准注册的一次性使用无菌注射器注册号编排方式为“国药管械，准，字2001第315 XXXX号” 二,国家食品药品监督管理局组建成立。2003年6月13日,国家食品药品监督管理局印发《关于修改医疗器械注册证编号的通知》(国食药监械〔2003〕98号),对医疗器械注册证号相应作如下调整: 由原 X 1药管械，X2，字XXXX3第X4 XX 5XXXX6号改为X1食药监械，X2，字XXXX3第X4XX5 XXXX6号。此调整从6月20日起适用于国家食品药品监督管理局发放的注册证。如国内2003年7月准注册的一次性使用无菌注射器注册号编排方式由原“国药管械，准，字2003第315 XXXX号”改为“国食药监械，准，字2003第315 XXXX号” 从这一阶段开始,国家局发放的注册号编排方式中的 “国药管械”一律改为“国食药监械”。 三,国家食品药品监督管理局《医疗器械注册管理办法》颁布。2004年8月9日,国家食品药品监督管理局发布第16号局令《医疗器械注册管理办法》。此时,医疗器械注册号的编排方式改变为:X，X，1，食，药监械，X2，字XXXX3 第X4XX5XXXX6 号。其中: X1为注册审批部门所在地的简称。境内第三类医疗器械、境外医疗器械以及台湾、香港、澳门地区的医疗器械为“国”字。境内第二类医疗器械为注册审批部门所在的省、自治区、直辖市简称。境内layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of 第一类医疗器械为注册审批部门所在的省、自治区、直辖市简称加所在设区的市级行政区域的简称,为XX1，无相应设区的市级行政区域时,仅为省、自治区、直辖市的简称，; X2为注册形式，准、进、许，。“准”字适用于境内医疗器械。“进”字适用于境外医疗器械。“许”字适用于台湾、香港、澳门地区的医疗器械; XXXX3为批准注册年份; X4为产品管理类别; XX5为产品品种编码; XXXX6为注册流水号。 如国内2004年9月准注册生产的一次性使用无菌注射器注册号编排方式为“国，食，药监械，准，字2004第315 XXXX号” 从这一时期开始,医疗器械产品取消试产注册,即境内产品只有准产注册一种形式,由各地方局审查发放的医疗器械注册证号也全部以“×，×，1，食，药监械”开头。 试剂分类，关于体外诊断试剂规范管理若干问题， 为了加强体外诊断试剂规范管理及使用,在选择体外诊断试剂时,首先要弄清体外诊断试剂的分类: layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of 一、按药品进行管理的体外生物诊断试剂包括: 1. 血型、组织配型类试剂，如血库用于鉴定ABO血型的抗A、抗B血清;鉴定Rh血型的抗D血清等。， 2. 微生物抗原、抗体及核酸检测类试剂，如免疫室常用的酶联法及金标法检测乙肝两对半试剂、丙肝、艾滋、梅毒检测试剂盒;PCR等， 3. 肿瘤标志物类试剂，如常用的AFP、CEA等， 4. 免疫组化与人体组织细胞类试剂 5. 人类基因检测类试剂 6. 生物芯片类 7. 变态反应诊断类试剂 二、按医疗器械管理的体外诊断试剂包括: 1. 临床基础检验试剂，如血细胞仦的配套试剂、上尿机的尿纸layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of 条、早孕条、隐血等临床时常用的试剂等， 2. 临床化学类试剂，如生化室使用的上机或手工生化试剂， 3. 血气、电解质测定类试剂 4. 维生素测定类试剂 5. 细胞组织化学染色剂类 6. 自身免疫诊断类试剂 7. 微生物学检验类试剂 另外,对供货方的合法性要了解,要求供货商提供以下资质文件: ，一，供货方的医疗器械经营许可证，注意检查准许经营有几类器械范围， ，二，供货方的药品经营许可证，要注意检查有无诊断药品这一项， layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of ，三，供货方的营业执照 ，四，所提供产品生产厂商的医疗器械或药品生产许可证，属于医疗器械的诊断试剂就必须有医疗器械生产许可证;属于诊断药品的诊断 药品就必须有药品生产许可证。， ，五，所提供产品的生产批准文号，属于医疗器械?类的,必须是国食药管械，准，×××号;属于医疗器械?、?类的,就由各省或直 辖市食药监局批准的××省或市食药管械，准，字，或，字×××字号;如果是进口产品,就必须提供进口注册证;属于药品的,必须是 国食药，准，字号。 ，六，所供产品生产厂家给供货商的授权书。 ，七，供货方出俱给销售人员的授权书。 以上文件的复印件需盖供应商鲜章 layout development cities in developed countries show that developing rail transit Guide and an important means of achieving sustainable urban development. More than the bulk of the urban rail transit vehicles, rail traffic in the urban space layout and guide the evacuation, optimizing the structure and other aspects also play an important role in its role as the scale becomes more important. Rail transit on land development and stimulation is achieved through its good accessibility, under the dual role of mechanisms in land and planning, transport accessibility high land along the rail transit development and high strength, promotion of urban morphology and land use patterns to adjust accordingly. 1, and Copenhagen 1947, Copenhagen refers to shaped planning introduced, requirements land development along narrow of finger corridor concentrated, refers to shaped planning guide big Copenhagen area along track traffic line clear defined of corridor for Metro development, through track traffic and city development of integration, will along development concentrated in track station around a km around, around track site land implementation integrated intensive development, and provides good of non-mobile of way received connection facilities, Ensure that a larger proportion of the region's residents commute using mass transit. Figure 5.1-3 Copenhagen Metro City Development 2, Tokyo 5.1-4 Tokyo Metro to guide regional development (left: 1950, right: 2000) formation is the mass transit system of the city of Tokyo, which have been developed under the guidance of. Eastern suburbs ... Established to track traffic based on the network-city, using rail-oriented intensive development mode has been recognized in many cities. Created the urban structure of the node, forming the urban rail transit-dependent and lifestyle, as well as mass transit systems provide adequate passenger protection. 5.1.3 to guide the healthy development of