印度的CDSCO发布了新的医疗设备清单to the 15 devices currently notified for mandatory registration in India, but the regulator appears to have broken down larger groups of devices such as “cannula” and “stents” into more specific sub-groups such as “ureteral stents” and “coronary stents.” CDSCO has classified these new sub-groups using risk assessment methods required by the Medical Device Rules 2017, still slated for early 2018 implementation.
Earlier manufacturers could sell medical devices in India without any jurisdictions. Since 2006 medical devices entering India must be incompliance with the Indian Medical Device Regulations set forth by the CDSCO. The CDSCO is responsible for印度的CDSCO发布了新的医疗设备清单该国的新药和临床试验构成了毒品标准。
- 到那个时刻CDSCO medical device license process，操188金宝搏网站靠谱吗纵子策略师使漫长的过程变得容易且流畅，最好的技术团队为您工作，并提供了出色的帮助，及时的响应和负担得起的费用结构。
- 188金宝搏网站靠谱吗操纵子策略师将协助您在CDSCO中注册医疗设备。任何希望合法规范市场，进口和出售印度的医疗设备之一的协会，协会都需要同意Cdsco India authorized agent for medical devices。我们将为您提供所需文件和材料的准备和提交给印度的相关监管机构。
For manufacturers and/or importers who have already applied for manufacturing/ import license for any of these devices before December 27th，2019年（发布实施的通知发布-S.O。4671（e）），申请应由CDSCO视为有效。他们可以从发行该命令（即6月28日）中最多进口6个月th, 2021) or until approval is granted for the submitted application, whichever is earlier.
India Medical Device Classification
医疗设备和Invitro诊断设备（IVD）存在单独的分类系统。这些类别中的每一个都根据与这些设备相关的风险程度分为4个类。
设备类 |
风险 |
A |
低风险 |
B |
Low Moderate Risk |
C |
Moderate – High Risk |
D |
High Risk |
Foreign manufacturers should appoint an Indian Authorized Agent (IAA) to market devices in India. The IAA shall possess active wholesale drug license in the 20B & 21B application forms. Foreign manufacturers may appoint their distributors or importers as the IAA. However, having an independent IAA, with no commercial interest, would provide required flexibility to appoint multiple distributors in India.
两个都印度的CDSCO发布了新的医疗设备清单entrants as well as companies currently selling such devices in the country will have to register with CDSCO by the April 2020 deadline in order to continue legally marketing these products.
印度的CDSCO发布了新的医疗设备清单
All the applications for both Notified and Non-notified devices must be submitted through online portal called SUGAM and the CDSCO manages the applications through the same portal.
- 非宣传设备：The devices not included in the list of Notified Devices are not regulated in India. However, these devices shall be listed in the CDSCO portal. Foreign manufacturers shall have an IAA based in India to market these devices.
- Notified Devices:There are 37 categories of devices listed in Notified list, which are regulated by the CDSCO and require prior approval from the CDSCO for marketing them in India. There are different types of application forms and the documentation requirements vary with the application form submitted to the CDSCO.
申请的选择根据本国批准，免费销售证书的可用性（FSC），申请人的性质，操作和设备类型而有所不同。经过详细评估应用程序后，CDSCO颁发了用于测试，进口或设备制造的许可证。
值得注意的夹杂物印度的CDSCO发布了新的医疗设备清单
While prior to the notifications in February, about the印度的CDSCO发布了新的医疗设备清单CDSCO仅监管了37个医疗设备，目前的方法似乎更宽了列表中的几种常用产品，例如：
- Spectacles (frames and lenses);
- 接触lenses;
- Public respirator masks (2 and 3 ply) – described as a “filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency.”;
- 设备，生育能力，诊断，避孕和软件应用 - 被描述为“旨在监控和提供生育信息以防止怀孕（避孕）”的软件”，例如，线索，FLO和其他可用的移动应用程序。
虽然CDSCO的相对无所作为关于修正案已经使医疗设备公司有一定时间适应新的印度的CDSCO发布了新的医疗设备清单, preparedness on the part of such companies would be key. As part of the application, they would be required to provide documentation such as: (a) a certificate of compliance with respect to the ISO 13485 standards (from an organization accredited by the National Accreditation Board for Certification Bodies or International Accreditation Forum); and (b) a free sale certificate from the country of origin of the medical device (applicable only to imported devices).
Companies should first assess whether their products fall within the list provided, and then make adequate arrangements with respect to the accompanying documents for the registration. Since these steps would have to be undertaken once the final Classifications are notified, companies would be well placed in keeping their documentation ready for the application.