Classification of medical devices & in vitro diagnostics are issued by DCGI under Medical Devices Rules, 2017

Classification of medical devices & in vitro diagnostics are issued by DCGI under Medical Devices Rules, 2017

即使作为医疗设备规则，2017年在2018年1月1日生效，印度（DCGI）的药物控制员将发布医疗设备的分类和in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017.

药物控制员将军（DCGI）是最终的权威，并控制医疗设备和药品。印度的药物控制器将负责认可特定药物类别的许可证，例如IV液体，血液和血液制品，血清，疫苗和所有医疗器械。DCGI已通知所有利益攸关方 - 医疗器械和体外诊断（IVD）医疗器械的分类，根据其医疗器械规则的规定，为其对其进口，制造，临床调查，销售和分配的监管。但是，医疗设备的安全性，质量和性能受到1940年的药物和化妆品法案的规定，并提出的规则。早些时候，中央政府，咨询后Drugs Technical Advisory Board(DTAB), had notified医疗设备规则(MDR), 2017 vide G.S.R. 78 (E) dated 31.01.2017, which are commenced from 01.01.2018.

The said notification is, in the exercise of the powers conferred under sub-rule (3) of rule 4 of MDR, 2017 that “TheCentral Licencing Authority医疗器械,应当分类referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule.”

Whereas, Rule 2 ofMDR, 2017 prescribes the applicability of these rules, in respect of :

  1. Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
  2. 包括机械避孕药（避孕套，宫内器件，输卵管戒指），消毒剂和杀虫剂在子项（II）下通知的物质;和
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of theDrugs and Cosmetics Act, 1940（1940年第23条）。

TheCentral Governmenthereby classifies the medical devices and IVD medical devices, based on the intended use of the device and other parameters specified in the First Schedule.

在此视图中，通知的医疗设备和体外诊断医疗设备列表进行以下参数：

  1. General intended use given against each of the devices is for guidance to the applicants who intend to furnish an application for import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
  2. The components and accessories to a medical device or companion in vitro diagnostic medical de- vices have been classified separately.
  3. It is also recognized that some of the medical devices or in vitro diagnostic medical devices may have dual-use and they may be classified accordingly.
  4. 此列表是动态的，在2017年医疗器件规则的规定下可能需要修改。

此外，通知列出了医疗设备和IVD deviceswith their risk classes:

  1. List A includes a total of 351 medical Devices in 16 categories with their risk class as per the provisions of Sub-rule (1) of Rule 4 of the MDR, 2017 which prescribes that “医疗设备shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:—
    1. 低风险 - A级;
    2. Low moderate-risk- Class B;
    3. 适度高风险-C;
    4. High risk- Class D.”
  2. List B includes a total of 247 in-vitro diagnostics medical devices in 22 categories with their risk class as per the provisions of Sub-rule (2) of Rule 4 of the MDR, 2017 which prescribes that “In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:—
    1. 低风险 - A级;
    2. Low moderate-risk- Class B;
    3. 适度高风险-C;
    4. High risk- Class D.”

在继续前进的通知申报档案：29 / MISC。/ 3/3 / 2017-DC（292）日期为01.11.2017关于医疗器械分类和在医疗器械规则的规定下的体外诊断医疗设备，2017年，Annexure-1 is hereby revised for the following changes: 1. Deletion of S.N. 333 i.e. Sterile Drapes. 2. Revision of risk class of the following products:

1.删​​除S.N.333即无菌窗帘。

2.修订以下产品的风险等级：

Thelist of medical devices and in-vitro diagnostics还与其风险课程一起提供了2017年医疗设备规则第4条的规定。

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