日本医疗器械注册申请,PMDA认证咨询辅导,日本对于医疗器械定义及分类管控

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 18575592846 发布时间:2020-06-23

在日本,医疗器械的分类采用的是编码式原型系统以及以规则为基础(根据GHTF分类规则进行)的风险评估体系相结合的分类方式。 日本医疗器械术语集(JMDN)代码明确标示了器械分类与注册登记路径信息。 医疗器械被细分为普通I类,特定管控II类,管控II类,特定严格管控III类,严格管控III类和严格管控IV类等类别。

Medical devices is regulated by the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as “the Pharmaceuticals and Medical Devices Act) , which came into effect in November 2014 (See Table 1) , and classified by risk base concept.

医疗器械受2014年11月生效的《确保药品、医疗器械、再生和细胞治疗产品、基因治疗产品和化妆品质量、疗效和安全法》(以下简称《药品和医疗器械法》)的监管(见表1),并按风险基础概念进行分类。


Each device is reviewed depending on its specific risk to the human body in case of problems happened.

1. For review of general medical devices, a self-declaration system is adopted.

2. Designated Controlled Medical Devices are to be certificated by the third-party certification bodies based on Certification Criteria (discussed below) which are pre-authorized by the Minister of Health, Labor and Welfare (hereafter MHLW). Other Controlled Medical Devices are reviewed by the Pharmaceuticals and Medical Devices Agency (hereafter PMDA).

3. Specially Controlled Medical Devices are to be reviewed by PMDA and approved by the MHLW. They are reviewed based on separately specified approval criteria or Guidance Documents which are authorized by the MHLW. Where some devices comply with specified certification criteria and authorized by the MHLW they are to be reviewed and certificated by the third-party certification bodies as a designated Specially Controlled Medical Devices.


PMDA classify the reviewing applications for medical devices are as follows:

1. New medical devices

Marketing applications for medical devices that have a clearly different structure, usage, indication, performance, etc., as compared to those which have already been approved for marketing (excluding devices subject to use-results survey specified in Article 23-2-9, Paragraph 1 of the Pharmaceuticals and Medical Devices Act and the survey is ongoing; hereafter "existing approved medical devices")


2. Improved medical devices (with clinical data)

Marketing applications for medical devices that do not fall under "new medical devices" or "generic medical devices"


3. Improved medical devices (without approval criteria, without clinical data)

Marketing applications for medical devices that do not fall under "new medical devices" or "generic medical devices" (limited to devices for which no clinical data are required to be submitted.)


4. Generic medical devices (without approval criteria, without clinical data)

Marketing applications for medical devices that are regarded as substantially equivalent to existing approved medical devices in terms of structure, usage, indications, performance, etc. (limited to devices for which no clinical data are required to be submitted.)


5. Generic medical devices (with approval criteria, without clinical data)

Marketing applications for medical devices that are regarded as substantially equivalent to existing approved medical devices in terms of structure, usage, indications, performance, etc. (limited to devices for which no clinical data are required to be submitted.) and that comply with approval criteria (discussed below)


根据发生问题时对人体的特定风险,对每个设备进行审查。

1、对于一般医疗器械的审评,采用自申报制度。

2、指定的受控医疗器械应由第三方认证机构根据卫生、劳动和福利部(以下简称MHLW)预先授权的认证标准(下文讨论)进行认证。其他受控医疗器械由药品和医疗器械管理局(以下简称PMDA)审查。

3、特殊控制的医疗器械应由PMDA审查并由MHLW批准。根据MHLW授权的单独规定的批准标准或指导文件进行审查。如果某些设备符合规定的认证标准并经MHLW授权,则它们将由第三方认证机构作为指定的特殊控制医疗设备进行审查和认证。              PMDA将医疗器械的审查申请分类如下:

1、新型医疗器械

与已经批准上市的医疗器械相比,具有明显不同的结构、用途、适应症、性能等的医疗器械的上市申请(不包括第23-2-9条规定的使用结果调查的器械,《药品和医疗器械法》第1款,正在进行调查;以下简称“现有批准的医疗器械”)              

2、改进的医疗设备(有临床数据)

不属于“新医疗器械”或“通用医疗器械”的医疗器械的营销应用  

3、改进的医疗器械(无批准标准,无临床数据)

不属于“新医疗器械”或“通用医疗器械”(仅限于不需要提交临床数据的器械)的医疗器械营销申请

4、通用医疗器械(无批准标准,无临床数据)在结构、用途、适应症、性能等方面被视为实质上等同于现有批准医疗器械的医疗器械营销申请(仅限于无需提交临床数据的器械)              5、通用医疗器械(有批准标准,无临床数据)在结构、用途、适应症、性能等方面被视为实质上等同于现有经批准的医疗器械(仅限于无需提交临床数据的器械)且符合批准标准(下文讨论)的医疗器械营销申请

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