India has made significant strides in the healthcare sector in the past few decades. In 2017, India's regulatory authority - the Central Drug Standard Control Organization (CDSCO) - published the Medical Device Rules, 2017, which came into force as of January 1, 2018. While the regulations brought more structure to India's developing regulatory framework, they also raised a number of questions.
In this white paper, we will discuss the key changes in the regulation and what this means for companies selling their devices in India. You will learn:
- new device classification rules
- how the regulation defines medical devices, IVDs, etc.
- fee revisions
- rules for manufacutring site audits
- and more.
Download our white paper for answers to your biggest questions about medical device market access in one of Asia's fastest-growing markets.