Case Study 24 : Registration of a Software as medical device in China, Columbia and South Korea for European AI based Company

Company Situation

The Client is a US based medical device company that developed a suite of innovative AI based software for multiple applications. The client has registered the software as medical devices in EU, USA, Canada, Australia, Brazil, Japan, Thailand and had planned to register in 10+ other global markets. With limited global presence and regional regulatory expertise, Client wanted a global partner to ensure their product approval in markets of interest.

GRP Solution

GRP with its extensive global experience with Artificial Intelligence based software as devices and regional presence across Americas, Asia-Pacific, Europe was preferred by client as one-stop-shop for all their regulatory and clinical needs. G

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More Resources:

South Korea's MFDS

The Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) is the governmental agency that regulates food, pharmaceuticals, medical devices, and cosmetics in South Korea.

China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).