New regulations for India's medical devices. / Image: Getty Images
Before February, medical device companies looking to penetrate the India market only needed an import license to do so. The $5.5 billion Indian medical device industry, which has been growing 17% annually, has some new regulations. A recent MedCityNews article outlined the top 10 things you need to know.
- The regulations go into effect next year.
- The old 10-device list has been replaced by four classes that will categorize all medical devices that will be sold in India.
- Online applications for licenses to sell and distribute can be completed online. (no duh.)
- Notified Bodies will audit manufacturing sites and products to ensure conformity to standards.
- Foreign manufacturing sites may be subject to inspection by India’s Central Licensing Authority.
- In 2020, approved medical devices must bear unique identifiers.
- Medical devices novel to the Indian market are subject to special regulations.
- Not all medical devices will require clinical investigation.
- Application fees are higher than before.
- Registration Certificates last for 5 years.
If you’d like more info on the aforementioned list, click here.
