WE WANT YOUR PROJECTS AND YOUR BUSINESS TO SUCCEED !
In order to legally import and market medical device/s in India, a manufacturer needs to be compliant to Indian regulations and legislation. Prior to 2005, no regulations existed for medical devices in India. At present, certain “notified” classes of medical devices, diagnostics and In Vitro Diagnostic (IVD) Devices are regulated under the provisions of the Drugs and Cosmetics Acts & Rules. A comprehensive legislation specific to medical devices is yet to be implemented.
The government of India has notified the requirement for registration of “Notified Medical Devices” through various Gazette Notifications. In other words, all notified medical devices are regulated and require appropriate approvals / licenses from the Indian Drug Regulatory Agency (licensing agency) – CDSCO to enable their import, manufacture, distribution and sale in India.
In summary, medical device manufacturer/s who wish to import and market their products in India, have to register their manufacturing site/s and product/s through their registered office in India, or their Subsidiary or through an Importer or a India based Authorised Agent.
Optimus provides both Market Authorisation Services / Device Registration Services as well as Authorised Agent Services. An end-to-end service offering which will help you import and sell your product in India, so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
Only one Indian Authorized Representative office is needed for the whole country. Optimus will represent you legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.
We provide “intelligent strategies“ instead of simplified, often cost-intensive routine Device Development Programs to ensure highest possible regulatory acceptance of your product. We thereby ensure effective compliance and thus help you, our customers navigate the complex, medical devices regulatory landscape and make right decisions. Hence, emerging and established medical device firms trust Optimus as their partner to deliver customized strategic guidance and creative “hands-on” solutions to categorise and register their products efficiently.
Product registration services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals
- India Specific Labelling and Instructions for Use leaflets
- Post marketing services including Complaint handling, Query management & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required Authorizations, Prepare and review regulatory submission material for compliance to India legislation etc.,