India combines many opportunities and many challenges for the medical device industry. India’s medical device market is currently the fourth largest market in Asia. With projected growth rates of 12-16% for the next five years, one cannot ignore India’s potential and vast market opportunity. This presentation will provide an overview of India’s medical device market as well as discuss the most recent regulatory issues.
To view these presentation slides, please click on Update on India’s Medical Device Markets Presentation
Table of Contents:
- Overview of India’s healthcare system
- Demographics
- Healthcare
- India’s medical device market
- Regulatory environment
- Regulators of medical devices
- New medical device regulations
- Proposed legislation
- Reimbursement
- Which medical devices require registration
- Product registration requirements
- Required forms
- Form 40
- Schedule D
- Required forms
- Registration process
- How to expedite the registration process
- Quality Assurance (QA)
- Good Manufacturing Practice (GMP)
- Schedule M
- Quality assurance
- Manufacturing license
- Labeling and packing
- Price control
- Intellectual Property Rights