How Does the DMAH Interact with the PMDA in Japan?

The DMAH interacts with the PMDA in Japan through a collaborative process. The DMAH submits applications and coordinates with the PMDA for regulatory review and approval. The PMDA evaluates the safety, efficacy, and quality of medical device and IVD products, while the DMAH acts as the responsible entity for marketing authorization and post-approval activities.

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