CDSCO Overview - India Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization is the Indian regulatory body for pharmaceuticals and medical devices, being the equivalent of the FDA in the US. The CDSCO is responsible for the regulating the manufacture, approval and sale of medical devices and drugs in India, for clinical trials as well as for providing expert advice on health issues and the enforcement of the Drugs and Cosmetics Act.
The department within the CDSCO responsible for regulating medical devices and drugs is known as the Drug Controller General of India (DCGI), in institution under the Indian Ministry of Health and Family Welfare. Inspections, audits, post-market surveillance and recalls are done through the department that is split into zonal offices.
Major Regulations
Some of the most important regulations for medical devices in India are:
- India Medical Device Rules 2017
- Clarification On Import And Manufacture Of Medical Devices
- Guidance Document on Common Submission Format for Registration of Medical Devices in India
A list of CDSCO regulations can be found here on our website.
Contact details:
Medical Device Associations in India:
有任何问题？向我们的专家获取相关信息
联系我们相关
-
韩国医疗器械法规框架及注册路径解读
我们的专家将详细解读2023年韩国食品药品安全部（MFDS）指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范（KGMP）等相关要求，并将依据多年韩国本地注册经验提供注册案例分享。此外，您还将了解到制造商在面对MFDS监管时需要关注的核心要点，相关研讨会内容包括：
阅读更多 -
欧盟医疗器械法规MDR 全新解读 – 共瞻2022医疗器械合规新要点
自新欧盟医疗器械法规MDR (Medical Device Regulation 2017/745) 申请日期起，欧盟医疗器械监管当局就发布了一系列新文件及相关支持服务，旨在帮助医疗器械制造商适应新法规变更后的法规环境。 对此，作为在全球范围内经验丰富的医疗器械及IVD器械市场合
阅读更多