WHITE PAPER: The New India Medical Device Rules, 2017
In this in-depth white paper, we review India's new Medical Device Rules, 2017 and what you should know to achieve CDSCO compliance.
Questions? Request more information from our specialists
CONTACT USIndia 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.
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