The Client is a South Korea based medical devices manufacturer who has developed a glucometer that it wanted to launch in Japanese market. Client had no experience with Japanese PMDA regulations and was not clear with product’s classification and applicable regulations, studies and documentation required for registration of the device.
GRP has successfully registered medical devices in Japan under different classes. GRP was retained as a partner of choice by the Client to help navigate applicable PMDA regulations on their device, develop a regulatory strategy and help register the product successfully in the market with GRP being the D-MAH for client in Japan.
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