India
India is one of the fastest-growing medical device markets in the world, driven by rising demand for healthcare products and regulatory reforms aimed at improving device quality.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health.
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Very high risk
Specific Local Requirements
| Language
|
Documentation in English. |
| Local Representative (Indian Authorized Agent) | Required for foreign manufacturers. |
| Certifications | CE, FDA, Free Sale Certificate, and ISO 13485 facilitate the process, although specific local standards also apply. |
Challenges and Operational Advice
- Evolving regulations: Constant updates on new requirements are essential.
- Complex distribution: A reliable local partner is crucial.
Why Choose ISEMED
- India Expertise: Support in managing processes with CDSCO.
- Comprehensive Assistance: From application submission to post-market management.
FAQ
- Is a local representative required? Yes, Indian Authorized Agent.
- Documentation language? English.
- License duration? 5 years.