Along with the global medical device market, the Indian medical device market has also observed steady growth. GlobalData’s research reveals that India’s medical devices market accounted for around 25 percent of the Asia-Pacific market in 2021.
India is a key market for medical device outsourcing. This industry has seen tremendous growth over the last few years. Several joint ventures, agreements, and loan licensing procedures have influenced the market and caught the eye of foreign manufacturers.
Key Growth Drivers of the Market
- The Indian government has allowed 100% foreign direct investment (FDI) in the medical devices industry. The inflow of FDI is expected to encourage research and development (R&D) activities and manufacturing innovations.
Challenges for the Indian Medical Device Market
- Standardization of Regulations: India's erratic regulatory framework is a significant obstacle for foreign manufacturers of regulated device types.
- Weak currency
In 2017, the Medical Devices Rules aligned the country’s regulatory structure with Global Harmonization Task Force (GHTF) guidelines requiring a four-way risk-based classification of medical devices while also granting perpetual licenses to manufacturers subject to fresh application and retention every five years. From a foreign manufacturer, these rules did away with the requirement for registration and the appointment of a local authorized agent became sufficient to facilitate imports into the country.
The Medical Device Amendment Rules 2020 laid down mandatory registration with appropriate authorities with different timelines for each class of equipment with infused not only transparency but also assures the quality of the products.
Means of Strengthening Indian Medical Device Market and Becoming Self-Reliant
- Endorsing start-up ecosystem
- Increasing exports
- Attracting more medical tourism
- Developing local manufacturing competences
Our partners, Yukon Medical, a US-based company, manufactures ViaLok Non-Vented Vial Access devices. These are used to access standard drug vials for needle-free drug preparation and administration and are distributed in India through Packaging Connections’ channels.