India Medical Device Regulatory Strategy Report

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.

Request Information from our Specialists

By submitting this form I am agreeing to receive periodic emails from UL LLC (UL), Emergo, and affiliates containing best practices, education, industry research, news, updates and promotions related to UL’s products and services. I understand that I can unsubscribe at any time and agree to UL’s Online Policies.

Please add @emergo.ul.com to your email’s Safe Senders List to prevent UL's emails from being sent to your spam folder.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.