US: +1 512 898-9222
SG: +65 3138-4148
India Independent License Holding
Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in India to submit registration applications to the Central Drugs Standard and Control Organization (CDSCO) and act as Authorized Representative. It is possible to use an independent license holding service as your Authorized Representative. This India Agent will be listed on the local labeling and is responsible for customs clearance and post market vigilance reporting.
Appointing a reliable, professional India Agent is the foundation of a successful business strategy in India.
Appointing Asia Actual as your India Agent provides clarity, confidence and control over your registration, importing and vigilance activities in India.
Asia Actual is a full-service provider of medical device license holder services in India. Contracting with us as your India Independent License Holder allows you to:
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Increase transfer pricing (as distributors are not investing in registration costs)
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
Contact Asia Actual to see if our India Independent License Holding service is right for your business.
India Regulatory Support
US: +1 512 898-9222
Latest Market Updates
- India Issues Final Notice Exempting Certain Class A Medical DevicesNovember 14, 2022 - 10:06 am
- Identifying Predicate Devices in India, Taiwan, China, Japan, and KoreaOctober 25, 2022 - 12:28 pm
- India Issues New Sales License Requirement for Medical DevicesOctober 10, 2022 - 12:10 pm
- India Grants Import License Grace Period for Class A/B DevicesSeptember 30, 2022 - 11:48 am
- India Issues Draft Notification for Exempting Certain Class A Medical DevicesSeptember 29, 2022 - 2:35 pm