Registering your medical device for sale in India means working with the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. Medical devices were initially brought under regulation in 2005 under the Drugs and Cosmetics Act, but regulators are developing new requirements for medical devices. Currently, only specific devices are subject to regulation.
Let Emergo assist you in evaluating the India medical device regulatory framework as it applies to your device(s)
Through our global network of consultants, regulatory sources and industry contacts, Emergo provides incisive analysis of many medical markets. Our Global Regulatory Overview report service for India covers the following issues:
- Regulatory Background on the CDSCO
- Product Assessment
- In-Country Representation
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap
Additionally, Emergo can develop reports customized to meet exact client specifications.
Please contact us for further information on our India Regulatory Strategy Consulting services.